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Eisai: Lenvima (Lenvatinib) in Combination with Keytruda (Pembrolizumab) Approved in Taiwan for the First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

TOKYO, Jan 31, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia.The approval is based on results from the CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination for the first-line treatment of patients with advanced RCC. These results were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.(1) In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the primary efficacy outcome measure of progression-free survival (PFS), as well as the key secondary efficacy outcome measures of overall survival (OS) and objective response rate (ORR) versus sunitinib. For PFS, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; pWorldwide, it is estimated there were more than 430,000 new cases of kidney cancer diagnosed and more than 180,000 deaths from the disease in 2020.(3) In Taiwan, there were more than 1,400 new cases and more than 600 deaths in 2018.(4) Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC.(5) Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases.(6) Approximately 30% of patients with RCC will have metastatic disease at diagnosistreatment for localized RCC.(7),(8). The prognosis for these patients is poor as survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 12% for patients diagnosed with metastatic disease.(8)Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals. *In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A.About LENVIMA (lenvatinib mesylate)LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.About CLEAR/KEYNOTE-581 TrialThe approval was based on data from the CLEAR (Study 307)/KEYNOTE-581 trial (ClinicalTrials.gov, NCT02811861), a Phase 3, multicenter, open-label, randomized trial conducted in 1,069 patients with advanced RCC with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting. Patients were enrolled regardless of PD-L1 tumor expression status. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Randomization was stratified by geographic region (North America and Western Europe vs. "Rest of the World") and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favorable vs. intermediate vs. poor). The primary efficacy outcome measure was PFS based on Blinded Independent Central Review (BICR) using RECIST 1.1, and PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumor expression status. Key secondary efficacy outcome measures were OS and ORR. Patients were randomized 1:1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). Treatment continued until unacceptable toxicity or disease progression as determined by investigator and confirmed by BICR using RECIST 1.1. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. KEYTRUDA was continued for a maximum of 24 months; however, treatment with LENVIMA could be continued beyond 24 months. Assessment of tumor status was performed at baseline and then every eight weeks.About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co- commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.In Taiwan, Eisai's pharmaceutical sales subsidiary Eisai Taiwan Inc. is marketing Lenvima and is co-commercializing it with a local branch of Merck & Co., Inc., Kenilworth, N.J., U.S.A.(1) Motzer R. et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. The New England Journal of Medicine.(2) The information listed in Taiwanese Package insert(3) International Agency for Research on Cancer, World Health Organization. "Kidney Fact Sheet." Cancer Today, 2020. bit.ly/3D0XjVA(4) Taiwan Cancer Registry Report.(5) American Cancer Society. Key Statistics About Kidney Cancer, bit.ly/3xwCY9i.(6) Padala, S. A., Barsouk, A., Thandra, K. C., Saginala, K., Mohammed, A., Vakiti, A., Rawla, P., & Barsouk, A. (2020). Epidemiology of Renal Cell Carcinoma. World Journal of Oncology, 11(3), 79-87. https://doi.org/10.14740/wjon1279.(7) Thomas A. Z. et al. The Role Of Metastasectomy In Patients With Renal Cell Carcinoma With Sarcomatoid Dedifferentiation: A Matched Controlled Analysis. The Journal of Urology. 2016 Sep; 196(3): 678-684. bit.ly/3obtpcF(8) Shinder B. et al. Surgical Management of Advanced and Metastatic Renal Cell Carcinoma: A Multidisciplinary Approach. Frontiers in Oncology. 2017; 7: 107. bit.ly/3IPFonTMedia Inquiries:Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai to Present Abstracts on Lenvatinib at 2022 ASCO Gastrointestinal Cancers Symposium

TOKYO, Jan 17, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022. At this symposium, the results of a primary analysis of a prospective clinical study evaluating transcatheter arterial chemoembolization (TACE) therapy in combination strategy with lenvatinib (TACTICS-L) in patients with unresectable hepatocellular carcinoma (uHCC) in Japan (Abstract No: 417), as well as research updates on the Phase IV Study (STELLAR) to evaluate safety and tolerability of lenvatinib in patients with advanced/unresectable hepatocellular carcinoma (Abstract No: TPS485) and results from a clinical study to evaluate the efficacy of lenvatinib for conversion surgery in patients with uHCC (investigator-initiated study in Japan, Abstract No: 458), will be presented. In addition, trial-in-progress (TiP) posters from the clinical program evaluating the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), include the Phase III LEAP-014 Study of the combination plus chemotherapy in patients with esophageal carcinoma squamous cell carcinoma (Abstract No: TPS367), Phase III LEAP-015 Study of the combination plus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma (Abstract No: TPS369), Phase III Study LEAP-012 of the combination plus TACE in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment (Abstract No: TPS494), and Phase II Study of the combination plus belzutifan in patients with advanced solid tumors (Abstract No: TPS669). In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib. Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers. This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials. Eisai's Focus on CancerEisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Biogen Announces Reduced Price for Aduhelm to Improve Access For Patients With Early Alzheimer’s Disease In The United States

TOKYO, Dec 21, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that, effective January 1, 2022, Biogen will reduce the wholesale acquisition cost (WAC) of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in the United States by approximately 50%. For a patient of average weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg) will be $28,200.Over the past several months, Biogen has listened to the feedback of our stakeholders. Too many patients are not being offered the choice of ADUHELM due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer?s disease. Biogen recognizes that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system and Biogen is now taking important actions to improve patient access to ADUHELM.Biogen is taking this action with the goal of lowering out-of-pocket expenses for patients and reducing the potential financial implications for the U.S. healthcare system. ADUHELM's reduced price takes into consideration the questions raised about this first in class of therapies, the potential eligible population and revised pharmaco-economic assumptions. Biogen believes with insurance coverage, and access to diagnostics and specialized centers, approximately 50,000 patients may initiate treatment with ADUHELM in 2022.It is a critical time for the Alzheimer's disease community as the Centers for Medicare and Medicaid Services (CMS) is considering the possibility of coverage of not only ADUHELM, but also this entire new class of Alzheimer's disease therapies that mainly have Abeta removing effects. We hope the actions today will facilitate patient access to these innovative Alzheimer's treatments.The reduced price is part of the Company's ongoing commitment to further inform treatment choice. Biogen recently presented new p-tau181 biomarker data at the Clinical Trials on Alzheimer's Disease conference (CTAD) and announced its plan to complete the Phase 4 confirmatory post marketing study of ADUHELM in an accelerated timeline of four years. ADUHELM's accelerated approval by the U.S. Food and Drug Administration has served as a catalyst for significant investment and additional research and innovation for Alzheimer's disease.In addition, the reduced price will have a minor impact on the consolidated result forecasts for the period ended March 31, 2022. There are no changes to the consolidated financial forecast announced on November 1, 2021. About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous useADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or "ARIA". ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient's healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.Cost, Coverage and Co-Pay AssistanceThe WAC of ADUHELM, which is an infusion once every four weeks, will be $2,171.40 per infusion for a patient of 74 kg?the average weight of a U.S. patient with mild cognitive impairment (MCI) or mild dementia. A 170 mg vial will be $479.40 and a 300 mg vial will be $846.00. The yearly cost at the maintenance dose (10 mg/kg) would be $28,200. The cost during the first year of treatment will be $20,500 due to the titration period. WAC is a list price and not the net price or the price paid by patients with insurance. The out-of-pocket cost for patients with insurance will vary depending on their coverage.For patients facing difficulty affording ADUHELM, financial assistance programs are available. For more information, please contact Biogen Support Services at +1-833-425-9360.Media Inquiries:Public Relations DepartmentEisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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New dialysis centre in Punggol to involve mobile patients in their own treatment for better health outcomes

SINGAPORE - A new dialysis centre was officially launched in Punggol on Sunday (Dec 5) that will see its mobile patients take responsibility for their dialysis sessions by measuring their own vitals and laying out medical supplies before starting treatment. This self-responsibility has been shown to improve patients' health outcomes as they are involved in their own treatment, said the National Kidney Foundation (NKF), which runs the new centre in Oasis Terraces at Punggol, in a statement. The new initiative is called "in-centre self-care". The more active and mobile patients will monitor their blood pressure and blood sugar levels, and learn proper handwashing steps before preparing and laying out the supplies required for dialysis, added the NKF. After the patient has opened and laid out the medical supplies, such as needles, alcohol swabs and saline solution, all the nurse has to do is insert the needles and cannula into the patient's arm and start the dialysis. The new centre brings the total number of NKF dialysis centres islandwide to 40, and it is the second largest after NKF's Integrated Renal Centre in Jurong West. It is also the first dialysis centre to be located in a new-generation neighbourhood centre such as Oasis Terraces, which also houses Punggol Polyclinic opposite the centre. Most other NKF centres are located at the void decks of Housing Board flats. "The centre's location in a neighbourhood centre means our patients are well-supported with easy access to affordable medical facilities, supermarkets, and food and beverage outlets," said NKF chief executive officer Tim Oei on Sunday. The centre has 35 dialysis stations and can take in up to 210 patients. It started operations in September 2019 and there are 208 patients receiving treatment at the centre currently. Initially planned for a mid-2020 launch, the centre's official opening was postponed because of the Covid-19 pandemic. On Sunday, Senior Minister Teo Chee Hean and Ms Yeo Wan Ling - both MPs of Pasir Ris-Punggol GRC - launched the new centre, named the NKF Dialysis Centre Supported by Ngiam Kia Hum & Family. Mr Ngiam is the managing director of Haneflex Singapore, a company that supplies fuel-handling equipment, and he has been a long-term donor with NKF. He started donating dialysis machines 15 years ago and wanted to help set up a new dialysis centre for the foundation. Mr Ngiam was spurred to support patients with kidney conditions after witnessing his old friend battle kidney disease many years ago. The new in-centre self-care initiative was introduced at the centre last month. Currently, one middle-aged patient has completed the training and five other patients have been identified to join the programme, said NKF. After undergoing a 2½-hour training with the centre's nurses, Madam Manisah Mohamad Salleh, 57, learnt to independently take her weight, measure her blood pressure, and remove medical equipment such as needles from the packaging in a safe and sanitary manner. For the past two weeks,  Madam Manisah Mohamad Salleh has been measuring her vitals and preparing her medical equipment on her own before starting dialysis. PHOTO: NATIONAL KIDNEY FOUNDATION Learning to read the data from her medical reports and dialysis machine helped her understand why she had to limit her fluid intake to one litre a day, and watch out for rising or falling blood pressure, which can cause side effects or complications during dialysis. For the past two weeks, the retired assistant childcare teacher has been measuring her vitals and preparing her medical equipment on her own before starting dialysis. As a patient with stage four kidney failure, Madam Manisah has to undergo dialysis three times a week, with each session lasting four hours. "I can be independent and I understand my condition better. It also helps to ease the nurses' workload, so they have time to focus on other duties. I know how to practise self-hygiene and protect (the dialysis site) against infections," said Madam Manisah. More on this topic   Related Story More people in S'pore getting kidney failure, but at a slightly later age   Related Story New dialysis centre at Toa Payoh West CC; NKF steps up community outreach Seriously ill or wheelchair-bound patients will not be eligible for the self-care programme. The NKF nursing team introduced the programme to the centre after reading about how patient-responsibility initiatives benefited those undergoing dialysis in the United States. Mr Oei explained: "When patients are more involved in their treatment plans, they are more optimistic about their condition and more motivated towards improving their health. "Various studies conducted in the US have shown that patients reported improvements in quality of life including enhanced energy, improved appetite, and reduced sleep disorders." On top of having to cope with the physical symptoms of kidney failure and the side effects of dialysis - including dizziness and pain - patients are also affected by other stressors such as the loss of autonomy, uncertainties about the future, and depression, noted NKF. The new programme aims to ease those challenges for patients. This programme for mobile patients will be progressively rolled out to other NKF dialysis centres, starting with those in the northern region. Mr Teo said at the launch that renal disease is a growing problem in Singapore, with the number of people diagnosed expected to rise given the country's ageing population and rising prevalence of chronic diseases. "This centre will serve our patients in the north-eastern region of Singapore, including Punggol and Sengkang... We hope that (the self-care component) will allow our patients to develop greater confidence and independence, as well as control of their health," he added. The new centre was set up with funds from Mr Ngiam and his family, other donors, and a grant from the Government.

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Eisai to Present Latest Data on Perampanel and E2730 at the 75th American Epilepsy Society Annual Meeting

TOKYO, Nov 30, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the company will conduct a total of 42 poster presentations, including the latest data on its in-house discovered and developed anti-epileptic agent (AED) perampanel (product name: Fycompa) and in-house discovered and developed E2730, an investigational novel small compound for AED and the treatment for neurological diseases, at the 75th American Epilepsy Society Annual Meeting (AES2021), to be held in Chicago, Illinois and virtually from December 3 to 7, 2021. Major presentations regarding perampanel include poster presentations about the analysis results from the phase III clinical trial (FREEDOM/Study 342), which evaluated long-term efficacy and safety of the perampanel monotherapy in the open-label extension (52 weeks) for epilepsy patients with focal-onset seizures (FOS) from 12 to 74 years of age without prior treatment history (Poster number: 1.283). Additionally, an overview of phase III and other clinical studies (Poster number: 2.218) and a real-world pooled analysis of perampanel for elderly patients (Poster number: 1.215), will be presented. For E2730, a poster presentation will be given on the non-clinical study results (Poster number 2.197). Perampanel is a first-in-class AED discovered by Eisai's Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. The agent is currently approved for partial onset seizures in over 70 countries including Japan, the United States, China and other countries in Europe and in Asia. The agent is currently approved as an adjunctive therapy for primary generalized tonic-clonic seizures in over 70 countries including Japan, the United States, and other countries in Europe and in Asia.E2730 is a novel selective uncompetitive GAT-1 (GABA transporter-1) inhibitor with a novel mechanism of action that selectively regulates activated synaptic functions, which was discovered by Eisai's Tsukuba Research Laboratories. Clinical study of E2730 for epilepsy is underway. Eisai considers neurology, including epilepsy, a therapeutic area of focus. Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy. Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.For more information visit https://www.eisai.com/news/2021/news202194.html.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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SAF to hand over management of Covid-19 home recovery programme to MOH

SINGAPORE - The Singapore Armed Forces (SAF) will hand over management of the Covid-19 home recovery programme to the Ministry of Health (MOH), Defence Minister Ng Eng Hen said on Wednesday (Nov 24). He did not indicate when this handover would take place. He wrote on Facebook that SAF commanders and other personnel tasked to manage the programme - which has become the default mode of care for Covid-19 patients with no or mild symptoms - have performed well. "They streamlined processes, introduced digital solutions as well as ensured the right care for different groups of residents infected with Covid-19," he said. He said now that the programme is stable, "it's a good time to hand over" to MOH, adding that a team of SAF advisers will "continue to remain embedded to ensure a smooth transition". The home recovery programme, which was piloted on Aug 30, initially faced teething issues, with members of the public saying they were unable to reach MOH for advice on their specific situation and were at a loss over what to do next. Subsequently, the Home Recovery Task Group was set up by the SAF on Sept 29 to help scale up and bolster the programme. In his Facebook post, Dr Ng shared that more than 450 personnel from the Singapore Army, Republic of Singapore Navy and Republic of Singapore Air Force (RSAF) were deployed. Full-time national servicemen worked as home recovery buddies. They provided the first line of contact to patients placed on the programme, assisted them with administrative procedures and ensured that communication channels remained open. Dr Ng also said that the RSAF's Innovation Office developed digital solutions, along with an automated SMS system, to streamline working processes that enabled a seamless management of large amounts of data from different parts of MOH. "A big thank you to our servicemen who stepped up when duty called, and for making a positive difference in helping residents recover safely at home," he added. "This prevented our healthcare system from being overwhelmed." The infection growth rate, which refers to the ratio of community cases in the past week over the week before, has been below one for 11 consecutive days. On Tuesday, there were 1,782 new Covid-19 infections reported, with the weekly infection growth rate standing at 0.83. A weekly infection growth rate that is consistently below one shows that the number of new weekly Covid-19 cases is falling. The intensive care unit utilisation rate was 55.2 per cent on Tuesday. In recent days, Singapore has further relaxed curbs on social and business activities. Restaurants and eateries, as well as a select number of hawker centres and coffee shops, are allowed to accept groups of up to five fully vaccinated diners from different households. People can gather in groups of up to five and receive a maximum of five visitors a day, up from two previously. More on this topic   Related Story Worries of those on home recovery justified, but good care system in place: President Halimah   Related Story S'pore GPs stepping up to provide telemedicine care for Covid-19 patients on home recovery

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Transgene and NEC Announce Positive Preliminary Data from Phase I Studies of TG4050, a Novel Individualized Neoantigen Cancer Vaccine

Strasbourg, France & Tokyo, Japan, Nov 23, 2021 - (JCN Newswire via SEAPRWire.com) - Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, today announce positive preliminary immunogenicity and clinical data on TG4050, their jointly developed individualized neoantigen cancer vaccine. TG4050 is the first candidate based on Transgene's myvac platform. Powered by NEC's cutting-edge AI capabilities, it is being evaluated in two ongoing multicenter Phase I trials in patients with ovarian cancer and head and neck cancer."We are extremely pleased to demonstrate the ability of TG4050 to effectively prime the immune system of the first patients who received this novel treatment and observe first signals of clinical activity. We believe this establishes the potential role of TG4050 as a new approach for individualized cancer vaccination. TG4050 appears to demonstrate a favorable safety profile thus far. We have also confirmed the feasibility of the "needle to needle" process with these two multicenter international Phase I trials, using our own internal manufacturing facility. Strikingly, when supported by NEC's powerful prediction tool, the myvac viral vector used in TG4050, which has been genetically optimized to improve immunogenicity and peptides presentation, induced robust and consistent response against class I and class II epitopes. We are working hard to complete the studies to further confirm these findings and generate additional immune and clinical data. We are very excited by the potential of TG4050 and hope to share additional data at a major oncology congress in 2022. Based on the additional data, we will identify the most appropriate path to take TG4050 forward," commented Hedi Ben Brahim, Chairman and CEO of Transgene."We are very excited to see early signs of clinical activity in the TG4050 clinical trials that uses our AI-driven neoantigen prediction system. NEC's proprietary machine learning algorithms are built upon decades of AI expertise, enabling us to prioritize and map the most immunogenic neoantigens on personalized vaccine blueprints. The safety profile and early immunogenicity data against multiple patient-specific tumor targets in the first patients is a testimony of TG4050's potential and of the complementary synergies between the two companies. This milestone illustrates the central role of expanding the AI approach for individualized cancer immunotheraphy. As we previously stated, NEC and Transgene share a common goal to harness the power of data and develop new targeted therapies in oncology. We continue to be hopeful that TG4050 will make a significant difference in the lives of patients throughout the world," commented Motoo Nishihara, Executive Vice President, CTO (Chief Technical Officer) and Member of the Board, NEC Corporation.Prof. Christian H. Ottensmeier, MD, PhD, Professor of Immuno-oncology, at University of Liverpool and Prof. Jean-Pierre Delord, MD, PhD, General Manager of IUCT Oncopole of Toulouse, will share their insights on these early results in two upcoming webcasts, respectively in English and in French (see details at the end of the release).TG4050 IS AN INDIVIDUALIZED NEOANTIGEN VACCINE TAILORED FOR EACH PATIENT.This individualized immunotherapy is based on Transgene's advanced virus engineering platform myvac and NEC's deep expertise in artificial intelligence (AI). TG4050 is based on an MVA viral vector which is designed to educate the immune system against each patient's most relevant tumor targets (up to 30 patient-specific neoantigens).These mutations are identified by next generation sequencing (NGS) and selected using NEC's proprietary AI-based immunogenicity prediction system. The main goal of the vaccine is to elicit a strong and long-lasting immune response against tumor antigens by targeting class I and class II epitopes. These two types of responses have been established as key factors in driving a sustained anti-tumor response.DATA WERE GENERATED FROM 6 PATIENTS THAT HAVE BEEN TREATED WITH TG4050 ACROSS THE TWO PHASE I CLINICAL TRIALS.The two studies are designed to assess biological and clinical activity of TG4050 given alone. In particular, the studies were designed to provide insights on the capacity of the selected target neoantigens to induce immune responses against these epitopes and, ultimately, to correlate clinical outcome with biological responses in two indications with significantly different genomic profiles.The two Phase I clinical trials are exploring the activity of repeated injections of TG4050 as monotherapy in patients with minimal residual disease:- In the ovarian cancer trial, patients receive the vaccine at first signs of asymptomatic relapse of their high grade, advanced-stage disease (after surgery and first-line chemotherapy). Asymptomatic relapse is defined as the detection of elevated CA-125 (tumor marker of ovarian cancer frequently associated with a relapse) or as low volume radiologic disease. The first patient was dosed in August 2020. Data have been generated from four patients treated in this trial.- Patients with HPV-negative, advanced-stage head and neck cancer are at high risk of relapse after surgery and adjuvant therapy. In the trial, they are randomized after completion of this primary treatment to receive vaccination (early treatment arm) or to receive TG4050 at relapse (delayed vaccination arm). In this trial, the first patient was dosed in January 2021. As of today, six patients were randomized in this trial, two in the early treatment arm and four in the delayed vaccination arm.Overall the data discussed today were obtained from the first six patients who received TG4050 across the two trials. The primary endpoints of these trials include safety and feasibility. Secondary endpoints include biological activity of the therapeutic vaccine TG4050.CELLULAR IMMUNE RESPONSE WAS EVALUABLE FOR 4 OF THE PATIENTS TREATED WITH TG4050.T-cell responses for each targeted mutation were assessed after 9 weeks of treatment with TG4050 and compared to baseline for the 4 patients for which evaluable samples were available. Neoepitope immunoreactive T-cells were quantified by ex vivo IFNgamma ELISPOT.- All 4 patients developed a robust T-cell response against multiple targeted mutations (neoantigens) with a median of 10 positive responses per patient, confirming the capability of the AI to accurately select immunogenic neoantigens across the two selected indications.- T-cell responses were observed for class I and class II epitopes. They consisted of de novo responses in 64% of observed responses (onset of response that were absent at baseline) and amplifications of preexisting responses for 36% of vaccine responses.- Additionally, the development of these adaptive responses was concomitant with maturation and activation of the patients' circulating immune cells, suggesting that the vaccine is able to effectively prime the immune system.Compared to previously reported neoantigen studies, these data reinforce the rationale for TG4050's prediction system and support the validation of the MVA vector as an efficient platform for anti-tumor vaccination.All immune assessments were conducted by the clinical immunology laboratory of Institut Curie (Paris).FIRST SIGNALS OF CLINICAL ACTIVITY ARE EXTREMELY PROMISING FOR TG4050In the ovarian cancer trial (n=4), one patient treated after an elevation of CA-125 experienced a normalization of CA-125 without clinical progression during 9 months until death from an unrelated chronic illness. Another patient with radiologic lesions is stable and is still under treatment with TG4050 9 months after the first injection.In the head and neck trial early treatment arm (n=2), the two patients have been treated with TG4050 for 10 and 5 months respectively and are stable. Their treatment is ongoing.To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported across the two studies. Adverse events are consistent with previous observations made with the MVA viral vector. They mainly consist of mild and transient symptoms, mostly injection site reactions.HIGHLY ENCOURAGING DATA POINT TO BE SHARED WITH THE COMMUNITY AND BE SUPPORTED BY ADDITIONAL DATA.Additional data will be generated in the coming months. Transgene expects to present them at a major oncology conference in 2022.In both clinical studies, enrollment and patient dosing are progressing in line with our expectations. Overall, Transgene plans to enroll 13 patients in the ovarian cancer trial and 30 patients in the head and neck trial.A conference call in English is scheduled on November 23, 2021, at 3:00 p.m. CET.A conference call in French is scheduled on November 23, 2021, at 8:30 a.m. CET.Replays will be available on the Transgene website (www.transgene.fr) following the live events.About the trialsTG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancers (NCT03839524) and HPV-negative head and neck cancers (NCT04183166).In a first Phase I trial, TG4050 is being administered to patients with HPV-negative head and neck cancer. A personalized treatment is created for each patient after they complete surgery and while they receive an adjuvant therapy. Half of the participants receive their vaccine immediately after they complete their adjuvant treatment. The other half is given TG4050 as an additional treatment at the time of recurrence of the disease. This randomized study is evaluating the treatment benefits of TG4050 in patients who have a high risk of relapse. Up to 30 patients will receive TG4050 in France, in the UK and in the USA. The principal investigator of the trial is Prof. Christian Ottensmeier, M.D., Ph.D., Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is being conducted, at Institut Curie, Paris, by Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) and at the IUCT-Oncopole, Toulouse, by Prof. Jean-Pierre Delord. In the USA, the trial is being led by Dr. Yujie Zhao, M.D., Ph.D., at the Mayo Clinic. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.In parallel, a Phase I clinical trial of TG4050 is enrolling patients with ovarian cancer. The first patient has been dosed in the USA. This second trial is including patients after surgery and first-line chemotherapy. Dr. Matthew Block, Consultant Medical Oncology, Consultant Immunology and Associate Professor of Oncology at the Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is being conducted by Prof. Le Tourneau at Institut Curie and by Dr. Alexandra Martinez, Associate Head of Surgical Department, at IUCT-Oncopole. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.About myvacmyvac is a viral vector (MVA - Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient's immune system, recognize and destroy tumors using the patient's own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future funding from Bpifrance for the development of its platform myvac". TG4050 is the first myvac-derived product being evaluated in clinical trials.About TG4050TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene's myvac technology and powered by NEC's longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC's Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.About NEC's Neoantigen Prediction SystemNEC's neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T cell response. With NEC OncoImmunity now onboard, NEC continues to strengthen its top class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide. For more information, visit NEC at www.nec.com. For additional information, please also visit NEC OncoImmunity at https://www.oncoimmunity.com/About TransgeneTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The Company's clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO platform).With Transgene's myvac platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.With its proprietary platform Invir.IO, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO collaboration with AstraZeneca.Additional information about Transgene is available at: www.transgene.frFollow us on Twitter: @TransgeneSAAbout NEC CorporationNEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.DisclaimerThis press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company's activities, perspectives, financial situation, results, regulatory authorities' agreement with development phases, and development. The Company's ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene's website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Around 40 patients in IMH Covid-19 cluster transferred to acute hospitals

SINGAPORE - Patients at the Institute of Mental Health (IMH) with more serious Covid-19 symptoms will be transferred to acute hospitals if required, IMH told The Straits Times on Thursday (Nov 4). And, so far, about 40 have been transferred. It said 16 staff and 278 patients have tested positive for Covid-19 in its cluster as at Wednesday (Nov 3). The cluster emerged last Monday (Oct 25), with 108 inpatients and eight staff infected then. On Thursday, IMH said it is working with the National Centre for Infectious Diseases to manage inpatients who have Covid-19. Most of its patient cases were asymptomatic or had mild symptoms and are managed in IMH. IMH said it is also working with the Ministry of Health to take measures to manage the cluster and minimise the risks of future clusters. IMH added: "We would like to assure the public that other wards in IMH and clinical services such as the outpatient specialist clinics continue to operate. "We will give priority to those who need crisis care and seek patients' understanding that they may experience longer waiting time in some of these clinical areas for regular care." More on this topic   Related Story How close is Singapore's healthcare system to its breaking point?   Related Story How close is Singapore's healthcare system to its breaking point?

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Still risk of Singapore’s healthcare system reaching tipping point

SINGAPORE - Six months ago, Indian hospitals turned away Covid-19 patients and pleaded for oxygen as supplies ran desperately low. A year before that, exhausted Italian doctors were forced to choose who to save among the many who needed intensive care. These scenes have played out in hospitals all over the world, whenever a new wave of infections threatens to swamp a country's healthcare system. Singapore's healthcare system is world-class. But now it, too, is being stretched to its limit. On Wednesday, the multi-ministerial task force tackling the pandemic said Covid-19 restrictions will be extended until Nov 21, as the system faces a "considerable risk of... being overwhelmed". Already, hospitals have postponed follow-up visits and elective operations to accommodate the rising number of Covid-19 patients, creating a backlog that will take months to clear. How close is Singapore's healthcare system to its breaking point? Singapore has chosen to maintain its stance rather than reverting to stricter measures, and that is one indication of where the country stands, said Professor Teo Yik Ying, dean of the Saw Swee Hock School of Public Health. "I would say the healthcare system is under pressure," he added. "But we are not at the stage where our doctors have to make hard decisions on ring-fencing hospital resources for some patients, and to give up on other patients." Professor Paul Tambyah, a senior consultant at the National University Hospital's (NUH) infectious diseases division, said that public hospitals in Singapore have relatively high bed occupancy rates compared with other high-income countries. In a way, this means doctors are "used to" making hard decisions about which patients can afford to wait, he said. "Most clinicians are taking the current surge in our stride, although it is challenging." Even so, the pressure is great. A commentary published last December in the Annals - the official journal of Singapore's Academy of Medicine - sheds some light on what local hospitals face. The Singapore General Hospital is the country's largest. It has 58 intensive care unit (ICU) beds in peacetime, although this can be increased to 120 beds if the need arises, the paper's authors observed. To do so, critically ill patients would have to be warded in high-dependency units, operating rooms and post-anaesthesia care units. Elective operations would have to be postponed. The authors added that the lack of skilled manpower is the "main bottleneck" for ICUs, where hospitals tend to maintain a very high 1:1 nurse to patient ratio. "Staffing for ICUs has traditionally been labour-intensive and this baseline shortage is compounded by the prolonged training required to achieve competency," they wrote. Although the number of Covid-19 patients who need critical care forms a tiny proportion of all cases, the demands they make on the hospital system are disproportionately large. In July, Health Minister Ong Ye Kung said Singapore can open 1,000 ICU beds for Covid-19 patients. It was an ambitious target: Two months later, there were only around 100 such beds. Now, it still has fewer than 300 ICU beds. To ramp up capacity to the 300-bed mark, the country will have to stomach "further degradation of normal service". More on this topic   Related Story S'pore hospitals under significant pressure; two-thirds of ICU beds occupied   Related Story S'pore public healthcare clusters to consider leave applications carefully based on staffing needs Singapore has 1,650 isolation beds for Covid-19 patients, 89 per cent of which were full as at Wednesday. It also has 200 dedicated ICU beds, which were taken up by 71 people on ventilators and another 75 who were admitted for closer monitoring. This is why the extension of Covid-19 measures has been deemed necessary, especially since the number of new cases shows no sign of falling yet. As Prof Teo put it: Each additional week that the rules are in place means more people getting booster shots or natural infections, giving them immunity against the virus and preventing numbers from shooting up when the rules are relaxed. It also gives front-line healthcare workers - who have been fighting this battle for nearly two years - a chance at a respite. Healthcare workers will be rostered for leave towards the end of this year, and have been given the green light to travel to countries with which Singapore has Vaccinated Travel Lane (VTL) arrangements. At the same time, each additional week of restrictions means money lost for businesses, and further dents the morale of a population that is chafing under rules that seem to have no clear end in sight. More on this topic   Related Story Extension of Covid-19 curbs leaves retailers 'in deep despair, disrepair'   Related Story Eateries frustrated by extended curbs, late notice of move It has been emphasised that Singapore's current position is different from that of other developed countries, where infection ran rampant and lives were lost before vaccination became widespread. Here, infections in the wider community were kept low. This is the first major wave that the country is experiencing, and vaccination has not quite managed to prevent the spread of the virus, even though it stops severe illness. But knowing this context does not make it any easier when one sees people in many other developed countries going about life as usual, with masks - the most visible symbol of the pandemic - noticeably absent in outdoor spaces. Could there be a middle-of-the-road solution? Professor Dale Fisher, also a senior consultant at NUH's infectious diseases division, believes so. The differentiated policies for unvaccinated people, which are already in place, could enable more opening-up, he suggested. Singapore's differentiated policies for unvaccinated people could enable more opening-up, said Professor Dale Fisher of the National University Hospital. ST PHOTO: DESMOND WEE If people who are not vaccinated are not allowed to join large groups in malls and hawker centres, fewer will fall ill and require ICU care. This means those who are vaccinated can be afforded more freedom. Singapore could also consider other easing measures, such as establishing more VTLs with other countries or even removing outdoor mask rules, Prof Fisher said. He suggested that curbs could focus on large indoor gatherings and other such indoor settings, while allowing more freedom outdoors. This is unlikely to lead to a big spike in infections but it would benefit people. "People should be allowed to walk their dogs without a mask," said Prof Fisher. More on this topic   Related Story Commentary: Better to bite bullet and roll back Covid-19 curbs than delay the inevitable   Related Story High vaccination rate, strain on hospitals among reasons for and against Covid-19 curbs: ST poll In other words, more elbow room for vaccinated people - who tend not to fall too ill - is not likely to lead to a rise in hospitalisations. Already, nearly three-quarters of infected people recover at home, and facilities have been set up outside hospitals to care for those who need closer watching. It is a very fine balance that is difficult to get right. But Singapore cannot stay in this limbo forever, and the solution cannot simply be more VTLs because Singaporeans need more than a temporary reprieve. What is needed is a concrete step forward - a move that impacts day-to-day life and reintroduces a sense of normalcy. Singapore may have to start small, but it has to start moving.   Related Stories:  Related Story S'pore's Covid-19 measures to be extended till Nov 21, to be reviewed at 2-week mark Related Story 3 positives and 3 negatives in S'pore's fight against Covid-19: Ong Ye Kung Related Story All healthcare workers in S'pore allowed to apply for overseas leave Related Story What is known about Covid-19 deaths in S'pore among adults under 60 Related Story Lack of Covid-19 vaccination passport, testing threaten Japan's reopening Related Story What scientists know about the risk of breakthrough Covid-19 deaths Related Story What the future holds for the coronavirus and us Related Story Once Covid-19-free, New Zealand prepares for 5,000 cases a week Related Story Why some nations have deadlier outbreaks with the same Covid-19 vaccines Related Story South Korea to ease curbs on social gatherings before switch to 'living with Covid-19'

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Singapore inks deal for antiviral pill to treat Covid-19 and its variants

SINGAPORE - The Republic has inked a supply and purchase agreement for an antiviral pill to treat Covid-19 that is said to be effective against all known variants of the virus, including the Delta variant. The drug was developed by pharmaceutical firm Merck in the United States and Canada, together with Miami-based Ridgeback Biotherapeutics. Merck is known as MSD elsewhere in the world.  The drug will be available in Singapore once it has received authorisation and approval for use, said MSD in an announcement on Wednesday (Oct 6). The Straits Times has contacted the Ministry of Health for comment. Known as molnupiravir, the drug comes in pill form and targets an enzyme that the virus needs to make copies of itself, by introducing errors into its genetic code. This particular enzyme - known as the viral polymerase - is conserved across different variants, making molnupiravir effective across the Gamma, Delta and Mu variants. Data from clinical trials suggests the drug is most effective when given early in the course of infection, said MSD. Interim trial results last Friday showed the drug may reduce the chance of hospitalisation or death by half for patients who are at risk of severe disease. The companies plan to seek US emergency use authorisation for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. "As the pandemic continues to evolve and surges are being reported in many places around the world, we are hopeful that we can make a meaningful impact on the pandemic through development of an effective oral antiviral that can be taken in the earlier stages of disease, outside of hospitalised settings to limit disease progression," said Dr Nick Kartsonis, senior vice-president, vaccines and infectious diseases, clinical research, MSD Research Laboratories. So far, Australia has entered advanced supply agreements with MSD to purchase 300,000 courses of the drug. Other places like South Korea, Thailand, Taiwan and Malaysia are also in talks with the company to purchase the drug. Commenting on the drug, infectious diseases specialist Leong Hoe Nam of the Rophi Clinic at Mount Elizabeth Novena said: "It is a useful adjunct to the high vaccine coverage in Singapore. Very significantly, we can arm our front-line doctors with the oral medication that may make a difference at the point of diagnosis. This may shift treatment from hospitals to general practitioners and polyclinics as Singapore pivots towards endemic living with Covid-19." Currently, molnupiravir is being evaluated as a Covid-19 treatment and a preventative drug. More on this topic   Related Story Merck says research shows its Covid-19 pill works against variants   Related Story Covid-19 antibody cocktail treatment to arrive in Singapore in October The global phase three treatment trial enrolled Covid-19 patients with mild to moderate Covid-19 who had symptoms for up to five days. All of them had at least one risk factor associated with poor disease outcomes, including obesity, diabetes, heart disease and those aged above 60. The trial results are expected early next month, said MSD. In anticipation of the results, MSD expects to produce 10 million courses of treatment by the end of the year, with more doses to be produced next year. The second trial, looking at molnupiravir as a preventative drug, will study the efficacy and safety of administering the drug to prevent the spread of Covid-19 within household settings. Results are likely to be available in the first half of next year. Local researchers had in their own study also identified molnupiravir as an effective drug against the original Sars-CoV-2 virus, as well as the Beta and Delta variants. A team led by Professor Dean Ho, director of the National University of Singapore's Institute for Digital Medicine, together with the DSO National Laboratories, found that molnupiravir, combined with baricitinib, an anti-inflammatory drug, could be a possible combination for Covid-19 treatment. Prof Ho had told ST in August that both drugs come in a pill format and can therefore be administered to those with mild illness who are recovering at home, or in a community care setting. More on this topic   Related Story Antiviral pill: How close are we to a drug to treat Covid-19?   Related Story Pharma companies and scientists worldwide race to develop Covid-19 cure   Related Stories:  Related Story Covid-19 antibody cocktail treatment to arrive in Singapore in October Related Story At least one long-term symptom seen in 37 per cent of Covid-19 patients: Study Related Story Nursing homes to test all residents, maintain separate zones to prevent spread of Covid-19 Related Story What to do if you have tested positive for Covid-19: 10 important steps Related Story US FDA leans towards authorising Moderna Covid-19 vaccine booster at half dose Related Story Covid-19 curbs necessary to prevent avoidable deaths: Lawrence Wong Related Story S'poreans socialising and dining out less, mental well-being has declined: Covid-19 survey Related Story Buddy system, ART tests: What does home recovery mean for Covid-19 patients? Related Story Chinese city Harbin orders spas, mahjong salons to shut after Covid-19 case confirmed Related Story Pet cats killed in Chinese city after Covid-19 infection, triggering social media anger

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Edison Oncology and Apollomics Announce Treatment of First Patient with EO1001 (APL-122) in a Phase I/IIa Clinical Trial

MENLO PARK, CA and HELSINKI, FINLAND, Oct 1, 2021 - (ACN Newswire via SEAPRWire.com) - Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop new therapies targeting the fight against cancer, and Apollomics Inc. ("Apollomics"), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination oncology therapies, reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors. EO1001 is a potent irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies."We are thrilled to see our first patient treated with EO1001 and hope that the potential safety and efficacy suggested by our preclinical data has the potential to translate into clinical benefits for patients suffering from cancer," said Jeffrey Bacha, B.Sc., MBA, Co-Founder and Chief Executive Officer of Edison Oncology. "Our preclinical studies have shown that EO1001 is potent against multiple activating mutations in the intracellular domain of EGFR. We look forward to the results from this first clinical trial as we believe EO1001 has the potential to address unmet medical needs in many types of cancer including non-small cell lung cancer, breast cancer and glioblastoma."The Phase I/IIa clinical trial will enroll up to 50 patients and is being conducted in Australia under contract service provided by Senz Oncology Pty Ltd. The objective of this first-in-human clinical trial is to examine the safety and tolerability of EO1001 in patients with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer. Patients with relapsed ErbB-positive cancers in solid tumors, including patients with central nervous system (CNS) involvement, will be enrolled at several clinical sites in Australia.Sanjeev Redkar, PhD, Co-Founder and President of Apollomics, added, "We are pleased to achieve this important milestone in the development of EO1001 which we refer to as APL-122. In preclinical models, APL-122 demonstrated activity in ErbB positive tumors and the ability to penetrate and treat cancers in the CNS. Therefore, this Phase I/IIa study is inclusive of patients with brain metastases. Advancing into human clinical trials marks a pivotal step in our development of this promising cancer therapy."Dr. Sophia Frentzas, medical oncologist and clinical researcher at Monash Cancer Center in Melbourne, Australia and Principal Investigator for the clinical trial said, "ErbB positive tumors represent a significant patient population with unmet clinical needs. These include patients with HER2 (ErbB2) positive breast cancer and EGFR (ErbB1) mutant lung cancer who have acquired resistance, or are refractory, to frontline targeted therapy. They also include those patients with other tumour types where the ErbB pathway has been increasingly shown to be a clinically significant oncogenic driver (e.g. GBM, endometrial, ovarian, bladder cancer and others). Cross-talk between ErbB family members is implicated in resistance to treatment and the growing incidence of central nervous system metastases plays a significant role in patient morbidity and mortality. In particular, the latter presents a significant limitation with currently available targeted therapies. EO1001 is an oral, brain-penetrating, uniquely potent, pan-ErbB inhibitor. We look forward to exploring its safety and efficacy in this first-in-human trial."On February 9, 2021, Edison Oncology and Apollomics announced an exclusive licensing agreement whereby Apollomics will develop and commercialize EO1001 (APL-122) globally, except in Mainland China, Hong Kong and Taiwan.About EO1001EO1001 is an irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, HER2 (ErbB2) which is prominent in breast cancer, and against the EGFR-variant III (EGFRvIII) that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well-tolerated and demonstrated the ability to enter the central nervous system (CNS) following oral dosing and activity against treatment-resistant EGFRvIII-driven tumors, including malignancies in CNS, in vivo. EO1001 is referred to as APL-122 by Apollomics.About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients.About Apollomics Inc.Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company's product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.Edison Oncology Contacts:Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.comMedia and Investor Relations Contact:Amato & Partners, LLCInvestor Relations Counseladmin@amatoandpartners.comApollomics Contacts:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.comPhoenix FungVice President(852) 3150 6773phoenix.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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S’pore GPs stepping up to provide telemedicine care for Covid-19 patients on home recovery

SINGAPORE - Several general practitioners (GPs) here have stepped up to provide telemedicine care for their patients who have been placed on home recovery, so as to ease the load of telemedicine providers, which have been stretched thin amid the surge in Covid-19 cases. They added doctors who are familiar with the patients can help allay their fears and offer more targeted medical advice based on their understanding of the patients' medical history. Dr Leong Choon Kit, a family physician at Mission Medical Clinic in Serangoon, told The Straits Times that over 300 GP clinics have expressed their interest to provide telemedicine services for the home recovery programme. Under his primary care network, 27 GPs signed up last week to provide round-the-clock telemedicine care for their patients under home recovery. Primary care networks are virtual groupings which allow doctors to pool resources and keep a closer eye on their patients. In addition, these GPs can provide medical advice to patients in quarantine should they begin developing any Covid-19 symptoms. All doctors who sign up under the home recovery programme will have to undergo a mandatory telemedicine training course, he added. "GPs are the foundation of our healthcare system. When people test positive for Covid-19 and start developing symptoms, many prefer to reach out to their GPs, whom they are familiar with, for advice and support," said Dr Leong. He had just attended to his first Covid-19 patient under the home recovery programme, and the patient remains "quite well". Other doctors said many of their patients had turned to them after finding difficulty in contacting the Ministry of Health or their telemedicine providers. Dr Lee Joon Loong, medical director of Paddington Medical Clinic in Bedok, said his clinic has received several calls from patients who had tested positive in both their antigen rapid test and polymerase chain reaction test, but have not heard from MOH on what they should do next. His team has stepped up to advise them in the meantime, pending the official call from the approved telemedicine providers. Since then, he has also expressed interest in joining the telemedicine home recovery programme. More on this topic   Related Story Telemedicine providers stretched thin as more people go into home recovery for Covid-19   Related Story 'This is poor planning': Covid-19 home recovery patients voice confusion, frustration over what to do Dr Kenneth Tan, a family physician at Kenneth Tan Medical Clinic in Punggol, told ST that two of his patients on the home recovery programme have not yet received medicine from their telemedicine providers. "If these patients were treated by their regular GPs instead, it would be easier to deliver medicine to them as the patients probably live close by," said Dr Tan, who has signed up for the home recovery programme. Similarly, Dr Tan Teck Jack, chief executive of Northeast Medical Group, said he signed up for the programme as family doctors can play an important role in addressing the fears and worries of Covid-19 patients, who would value reassurances from doctors who know them. He added that GPs are also able to pick up any signs of deterioration quickly. However, Dr Kenneth Tan said that telemedicine alone may sometimes not be adequate in assessing if a patient's condition is worsening, and patients who are not tech-savvy may not reach out to their telemedicine provider for help. Currently, Covid-19-positive patients who require in-person assessment of their condition have to be assessed in hospital accident and emergency (A&E) departments, he noted. According to MOH's website, those who are on home recovery should call an ambulance immediately if they experience worsening of any of these symptoms: shortness of breath or difficulty breathing, chest pains or pressure on the chest, and palpitations (fast beating of the heart). Instead of making Covid-19 patients go directly to the A&E department when they have these symptoms, Dr Tan suggested allowing GPs to conduct in-person assessments for certain groups of patients when necessary. "We've been seeing Covid-19 patients since the start of the pandemic, so we know the signs and symptoms of Covid and the common complications, and we will be able to refer them appropriately for hospital care," he added. More on this topic   Related Story What should I do if I get Covid-19 but MOH has not called me?   Related Story Buddy system, ART tests: What does home recovery mean for Covid-19 patients?

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Covid-19 antibody cocktail treatment to arrive in Singapore in October

SINGAPORE - More treatments are now available here for Covid-19 patients, as Singapore continues to battle against a rising number of coronavirus infections. The latest addition to this arsenal of treatment options is a Covid-19 antibody cocktail, which was developed by Regeneron and Roche. It is expected to arrive here next month or so, the National Centre for Infectious Diseases (NCID) said on Tuesday evening (Sept 28) in response to queries from The Straits Times. This monoclonal antibody treatment can be used to treat patients who are mildly sick but at risk of severe illness. It was granted interim authorisation to be used for the treatment of patients with mild to moderate Covid-19 under the Pandemic Special Access Route (PSAR) by Singapore's Health Sciences Authority (HSA) on Sept 21. HSA said on its website that infectious diseases specialists will be able to use this therapy for those aged 18 and older, who do not require oxygen supplementation and are at risk for progression to severe Covid-19. An ongoing phase three study that HSA reviewed has found that this antibody treatment cut the relative risk of Covid-19 disease progression to requiring acute treatment in hospital or death by 70 per cent, compared with the placebo group. Symptoms also cleared up an average of four days earlier compared with the placebo group. On Sept 24, a World Health Organisation panel also recommended the use of this antibody cocktail for patients at high risk of hospitalisation and those severely ill who had no natural antibodies. The treatment was granted US emergency use authorisation in November last year, having gained attention when used to treat former president Donald Trump's Covid-19 illness last year. Europe is reviewing the therapy, while Britain approved it last month. Apart from this antibody cocktail treatment, there are four other drugs in use to treat Covid-19 here. Antibody drug sotrovimab As at Sept 22, 64 NCID patients here have been on sotrovimab. The drug was made available to healthcare institutions from this month. Sotrovimab is a single-dose monoclonal antibody drug administered through intravenous infusion. Monoclonal antibodies are laboratory-made proteins that act like antibodies in helping the body to fight off infection. It can be used to treat patients who do not require oxygen supplementation and have mild to moderate Covid-19 disease but are at risk of progressing to more serious illness. The drug, developed by GlaxoSmithKline and Vir Biotechnology, was granted interim authorisation under the PSAR by HSA on June 30. More on this topic   Related Story WHO backs Regeneron Covid-19 drug cocktail as UN body calls for equal access   Related Story Regeneron Covid-19 therapy cuts deaths among hospitalised patients who lack antibodies: Study Arthritis drug tocilizumab and steroid dexamethasone As at Sept 22, 60 NCID patients have been on tocilizumab and another 290 on dexamethasone. Manufactured by Swiss drugmaker Roche, tocilizumab is an intravenous anti-inflammatory monoclonal antibody used to treat rheumatoid arthritis. It has been reported to reduce the risk of death in hospitalised patients with severe Covid-19, especially when combined with the steroid dexamethasone, a cheap and widely used steroid used to reduce inflammation in other diseases. These drugs are given to patients in intensive care with hyper-inflammation and have been shown to decrease mortality, Dr Shawn Vasoo, clinical director of NCID, said. Researchers in Britain have also found that the drug also shortened patients' length of stay in hospitals and reduced the need for a ventilator. The study was part of the Recovery trial, an international clinical trial that has been testing a range of potential treatments for Covid-19 since March last year. Antiviral drug remdesivir Remdesivir is developed by US drugmaker Gilead Sciences. PHOTO: REUTERS As at Sept 22, 580 NCID patients have been treated with remdesivir. Administered in the early stage of Covid-19 illness, it hastens time to recovery. Remdesivir, developed by United States drugmaker Gilead Sciences, received conditional approval from HSA to be used outside of clinical trials in June last year. More on this topic   Related Story Remdesivir averts hospitalisation in study of high-risk Covid-19 patients   Related Story S'pore inks deal with GSK to purchase Covid-19 drug sotrovimab There are also some repurposed drugs that have not proven useful for Covid-19 treatment. Dr Vasoo said that while some of these drugs may have demonstrated activity against the virus in a lab setting, their results in real-life clinical studies still remain to be seen. The definitive way to assess a drug's efficacy is through a double-blind randomised controlled trial in which at least two groups of patients get the drug or placebo or receive standard care, and neither the investigators nor the patients are aware of what treatment was given. Some of these drugs include: Ivermectin, a medication used to treat parasitic infections While many have called for ivermectin to be used as part of an outpatient treatment plan for Covid-19, data regarding it has been fraught with inconsistencies, Dr Vasoo said. At least two double-blind randomised controlled trials purporting its use showed serious flaws, with one being retracted for possible plagiarism and data flaws and the other exhibiting problems in its methodology and results, Dr Vasoo explained. Other more robust randomised controlled trials have not shown ivermectin to have any effect in preventing hospitalisation or an earlier resolution of symptoms, he said. "Ivermectin cannot be recommended at this point as part of the standard therapy of Covid-19, outside of well-designed clinical trials," Dr Vasoo said. More on this topic   Related Story ‘You are not a cow’: US FDA issues warning after use of livestock drug ivermectin to treat Covid-19 Anti-malaria drug hydroxychloroquine and antiretroviral drugs Hydroxychloroquine and antiretroviral drugs commonly used to treat the human immunodeficiency virus (HIV) - such as lopinavir-ritonavir - have not shown efficacy in randomised controlled trials to date, Dr Vasoo said. "The major definitive trials which have informed practice have been completed. It is unlikely that any further new, ground-breaking trials will be attempted," he said. Gout medication probenecid Probenecid, a medication that is primarily used to treat gout and has broad antiviral properties, was studied in the lab and showed activity in blocking replication of Sars-CoV-2, the virus that causes Covid-19. However, there is no current robust human trial data yet, Dr Vasoo said. At present, Singapore is not looking into this drug in relation to Covid-19 treatment. More on this topic   Related Story Japan's Shionogi to make 1m doses of new Covid-19 treatment by early 2022   Related Story Merck says research shows its Covid-19 pill works against variants

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Eisai: Fully Human Anti-TNFalpha Monoclonal Antibody HUMIRA Obtains Additional Approval

TOKYO, Sep 27, 2021 - (JCN Newswire via SEAPRWire.com) - AbbVie GK, Eisai Co., Ltd., and EA Pharma Co., Ltd announced today the additional approval for a high- dose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients regarding fully Human Anti-TNFalpha Monoclonal Antibody HUMIRA (generic name, adalimumab [recombinant]; "HUMIRA").This approval allows for 40 mg weekly treatment or 80 mg biweekly treatment in addition to conventional 40 mg biweekly treatment as a remission maintenance therapy, which is expected to maintain remission in many patients. Furthermore, by having been added as a treatment option for ulcerative colitis in pediatric patients, it is expected that as the first at-home/self-injectable drug in Japan for pediatric patients with ulcerative colitis, HUMIRA will improve convenience for pediatric patients and their guardians in addition to reducing burdens due to hospital visits.Ulcerative colitis (UC) is designated as an intractable disease in Japan. It is characterized by intestinal inflammation of unknown cause and subsequent damage to the colonic mucosa that results in erosion (a sore lesion) or ulceration. Patients with UC experience chronic diarrhea and hematochezia, abdominal pain, fever, anemia, etc. These symptoms resolve (remission) and flare up (relapse) repeatedly. It remains a long-term condition that is not adequately controlled in some patients; more treatment options are needed.(1),(2) Although the etiology of UC is still unclear, it may be associated with abnormalities in the immune system that protects the body from bacteria and other foreign substances. About 220,000 people suffer from UC in Japan and the number is increasing year by year.(3) Many patients receive a diagnosis of UC in their late 10s to early 30s. The disease rarely develops in childhood, with an estimated prevalence in Japan of 15 per 100,000 between the ages of 0 to 19.(4)In both adults and pediatric patients, the goal of treatment for UC is achieving long- term maintenance of remission with drug treatment. However, total colectomy may eventually be required in 30% of patients with severe UC. 5AbbVie GK Eisai Co., Ltd. EA Pharma Co., Ltd.In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA. Abbvie and Eisai are co-promoting HUMIRA for the indications in the fields of rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, uveitis, pustular psoriasis, hidradenitis suppurativa and pyoderma gangrenosum. For the indications in the field of gastrointestinal disease (i.e., Crohn's disease, intestinal Bechet's disease and ulcerative colitis), AbbVie is co-promoting HUMIRA with EA Pharma, commissioned by Eisai for promotion.AbbVie, Eisai and EA Pharma are committed to make a further contribution to treatment for patients with autoimmune diseases through providing more treatment options to adult and pediatric patients with UC.About HUMIRAHUMIRA is a fully human anti-TNF-alpha monoclonal antibody. In Japan, it is approved for "the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage); hidradenitis suppurativa, pyoderma gangrenosum, the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis,* intestinal Behcet's disease, and non-infectious intermediate, posterior and panuveitis that are refractory to the conventional therapies, induction and maintenance therapy for moderate to severely active Crohn's disease (limited to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis** (limited to patients who have had an inadequate response to conventional therapy )."(*) HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is approved. HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved(**) HUMIRAforSubcutaneousInjection20mgSyringe0.2mLisapprovedonlyforpediatricpatients.Nonproprietary name: Adalimumab Brand name: Fully Human Anti-TNF-alpha Monoclonal Antibody "HUMIRA for SubcutaneousInjection 20 mg Syringe 0.2 mL; HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL; HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL; HUMIRA for Subcutaneous Injection 40 mg Pen 0.4 mL; and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL"Details of the above approval (Underlined text indicates newly approved dosage and administration)Dosage and administration (only the section of UC is excerpted.)Adults:The usual initial dose of adalimumab (recombinant) is 160 mg administered by subcutaneous injection, which is followed by 80 mg administered 2 weeks after the initial dose. After 4 weeks of the initial dose, 40 mg of adalimumab is subcutaneously injected once every 2 weeks. However, after 4 weeks of the initial dose, adalimumab can be subcutaneously injected at 40 mg once weekly or at 80 mg once every 2 weeks, depending on the patient's condition.Pediatric patients:For pediatric patients weighing 40 kg or more, the usual initial dose of adalimumab (recombinant) is 160 mg administered by subcutaneous injection, which is followed by 80 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 40 mg once weekly or at 80 mg once every 2 weeks.For pediatric patients weighing 25 kg or more and less than 40 kg, the usual initial dose of adalimumab (recombinant) is 80 mg administered by subcutaneous injection, which is followed by 40 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 20 mg once weekly or at 40 mg once every 2 weeks.For pediatric patients weighing 15 kg or more and less than 25 kg, the usual initial dose of adalimumab (recombinant) is 40 mg administered by subcutaneous injection, which is followed by 20 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 20 mg every 2 weeks.About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.About EisaiEisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. For more information about Eisai Co., Ltd., please visit www.eisai.com. About EA PharmaEA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year's history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing.For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/en.(1) Australian Crohn's and Colitis Association (ACCA). The Economic Costs of Crohn's Disease and Ulcerative Colitis. 2007 Jun.(2) Romano C, Syed S, Valenti S, Kugathasan S. Management of acute severe colitis in children with ulcerative colitis in the biologics era. Pediatrics. 2016 May; 137(5):e20151184. doi: 10.1542/peds.2015-1184.(3) Research committee of inflammatory bowel disease, Research program on rare and intractable diseases, Health, Labour and Welfare Sciences Research Grants. For the patients of ulcerative colitis, the basic knowledge of treatments. Revised in 2020, March.(4) Ishige T, Tomomasa T, Hatori R, et al. Temporal trend of pediatric inflammatory bowel disease: analysis of national registry data 2004 to 2013 in Japan. J Pediatr Gastroenterol Nutr. 2017; 65(4):e80-e2.(5) Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec; 65(12):100851.Contact Information:AbbVie GKPublic AffairsTEL: +81-(0)3-4577-1112Eisai Co., Ltd.Public Relations Department TEL: +81-(0)3-3817-5120EA Pharma Co., Ltd. Corporate Planning Dept. TEL: +81(0)3-6280-9802 Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin

SHANGHAI, Sep 26, 2021 - (ACN Newswire via SEAPRWire.com) - Hua Medicine ("Hua Medicine"; SEHK: 2552) today announced that at the 6th China BioMed Innovation and Investment Conference held September 25-27 in Suzhou, China (the "CBIIC"), Professor Jianhua MA, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, as one of the principal researchers, presented the results from a clinical study called DREAM, which showed that dorzagliatin, a glucokinase activator and a first-in-class investigational drug of Hua Medicine, may make progress in diabetes remission.The DREAM study is an observational, non-pharmacologic and non-interventional clinical study initiated by certain researchers participating in the SEED study (also known as HMM0301). The SEED study is a Phase III registered clinical study of dorzagliatin monotherapy in drug-naive Type 2 diabetes patients to observe its long-term efficacy and safety. The main objective of the DREAM study is to evaluate the ability of Type 2 diabetes patients who participated in our SEED Study and achieved glycemic control as defined by investigators, to maintain normal to near-normal glucose levels (i.e., remission of Type 2 diabetes), without any glucose-lowering medication after the completion of the SEED study for a minimum follow-up period of 52-weeks.The DREAM study was conducted in a total of 69 patients in five clinical sites in China. The researchers comprehensively evaluated the subjects and set their individual HbA1c control goals, and the results of the research showed that the subjects had a 52-week glucose remission rate of 65.2% (95% CI, 53.4%, 77.0%) [1] during the research period.Professor Jianhua MA said, "Dorzagliatin, a new class of glucokinase activator, has demonstrated the ability to effectively improve early phase insulin secretion and beta cell function and insulin resistance resulting in Type 2 diabetes remission. In the previous SEED study, dorzagliatin monotherapy also demonstrated stable long-term efficacy and a good safety profile. The DREAM study again showed positive results, where patients who reached normal blood glucose level after dorzagliatin treatment were able to maintain their blood glucose level and beta cell function after discontinuation of medication. This result will help us gain a deeper understanding of the mechanism of diabetes remission and explore more effective therapy for patients in clinical treatment. The DREAM study explores the possibility of oral dosing in diabetes remission and is of great significance in expanding the treatment options for Type 2 diabetes."At the CBIIC, in addition to the DREAM study results, Dr. Li CHEN, CEO, Founder and Chief Scientific Officer of Hua Medicine, also analyzed the landscape of medication for Type 2 diabetes and shared Hua Medicine's development experience and future outlook at the session of Listed Company Roadshow.Dr. Li CHEN said that, "China has the largest number of diabetes patients in the world, with the number of Type 2 diabetes patients in China exceeding 120 million. According to an epidemiological study published in BMJ by Chinese researchers in 2020, the prevalence of diabetes and prediabetes in China was 12.8% and 35.2%, respectively, from 2015 to 2017, and diabetes prevention and control have become a strategic imperative in addressing this major public health issue. The consensus report on diabetes remission recently released by the American Diabetes Association has sparked new thoughts among clinicians and new drug developers about how to prevent diabetes from becoming a lifelong disease. The positive results of the DREAM study have strengthened our confidence in the cure of Type 2 diabetes. Hua Medicine will continue to explore the broad prospects of monotherapy and combination therapy based on dorzagliatin, while further conducting typing studies and using a combination of big data and artificial intelligence for the precise treatment of Type 2 diabetes. Hua Medicine will also actively establish a glucokinase drug development platform based on the unmet clinical needs of the general public in China, and strive to make new breakthroughs in the fields of neurodegenerative diseases, NASH and other diseases."Note:[1] Calculated using the Kaplan-Meier methodology.About DorzagliatinDorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.About Hua MedicineHua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide. Hua Medicine is listed on the Stock Exchange of Hong Kong Limited (stock code: 2552.HK)About DREAM StudyThe DREAM Study is an observational study designed and conducted by certain lead investigators who had participated in the SEED Study to evaluate the efficacy of dorzagliatin in drug-naive Type 2 diabetes patients. The Company did not design or control the DREAM Study and does not own or control the study's underlying data, although the Company has provided assistance to the investigators in evaluating related data and findings.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.comPorda Havas International Finance Communications Group Mr Bunny Lee +852 3150 6707 bunny.lee@pordahavas.comMs Louisa Chen +86 75523807432 louisa.chen@pordahavas.comMs Karen Chiu +852 3150 6726 karen.chiu@pordahavas.comMs Winnie Tan +852 15915975512 winnie.tan@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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First stepped-up community care facility in Tampines receives its first patients

SINGAPORE - The first patients have arrived at Singapore's first stepped-up community care facility (CCF) in Tampines when it opened on Thursday (Sept 23). At around 11am, three Covid-19 patients were seen making their way out of specially-hired vehicles along Tampines Street 22 where the facility is located. Staff decked in personal protective equipment (PPE) rolled out wheelchairs to receive two of them, both elderly women. One of them wore a fever patch on her forehead. The drivers of the vehicles also wore PPE. The front windows of the car were rolled down. The CCF, at the site of NTUC Health nursing home, has been fitted with 250 beds meant for Covid-19 patients who are generally well, but have underlying health conditions that require close monitoring. These patients will include the elderly and those who have chronic illnesses such as cardiac, neurological or respiratory ones. Infected nursing home residents will be prioritised for admission, in order to prevent further spread in such facilities. The CCF will have more medical and nursing staff than a typical nursing home. The Ministry of Health said that existing residents at the NTUC Health have been transferred to other branches. Stepped-up CCFs will help to reserve the limited hospital capacityfor only Covid-19 patients who need close and specialised medical attention - such as oxygen supplementation or intensive care. Covid-19 patient arriving at NTUC Health nursing home on Sept 23, 2021 More on this topic   Related Story Stepped-up care facilities to ease load on hospital beds   Related Story 10-15% of Covid-19 patients in S'pore likely to need hospital care once situation stabilises

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Eisai to Present Abstracts on Oncology Products and Pipeline at ESMO Virtual Congress 2021

TOKYO, Sep 14, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that presentations on a series of abstracts highlighting updates on its oncology products and pipeline will be given at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, from September 16 to 21, 2021, including its in-house discovered lenvatinib mesylate (product name: LENVIMA, an orally available multi-kinase inhibitor, "lenvatinib") and eribulin mesylate (product name: HALAVEN, a halichondrin class microtubule dynamics inhibitor, "eribulin").At this congress, differences in outcomes by histology and prior therapy in the pivotal Phase 3 Study 309/KEYNOTE-775 trial, which compared the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), with TPC (Treatment of Physician's Choice) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen, will be presented as an oral presentation (Abstract No: 726MO). In addition, a subgroup analysis and safety update from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581), which compared the combination of lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC) will be presented as an e-poster presentation (Abstract No: 660P). Additionally, e- poster presentations will be given on the outcomes of early clinical studies on a liposomal formulation of eribulin plus nivolumab (Abstract No: 980P), a CREB-binding protein (CBP)/β-catenin interaction inhibitor E7386 (Abstract No: 473P) and a compound derived from total synthesis of halichondrin, E7130 (Abstract No: 545P).In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.For more information, visit https://www.eisai.com/news/2021/pdf/enews202173pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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People with long Covid feared to be at risk of developing dementia

SINGAPORE - Weeks or months after they recover from Covid-19, some people continue to report poor concentration, memory difficulties and other cognitive issues, which experts fear may put them at risk of dementia years later. There is also growing concern that some of these "long-haulers" may get the dementia-related changes earlier than expected. The United Kingdom's National Institute of Clinical Excellence defines long Covid as having more than four weeks of symptoms after having Covid-19. The Alzheimer's Disease International (ADI), a federation of Alzheimer's associations around the globe, recently said that it had formed a working group of global experts to study the magnitude of the problem and make recommendations on how to deal with it. It warned that the current pandemic could lead to a surge in dementia cases, and called for urgent research to be done on the link between long Covid and dementia. Anything that diminishes a person's cognitive reserve and resilience is going to allow neurodegenerative processes to accelerate, said United States-based cognitive disorder neurologist Alireza Atri, who chairs ADI's 75-member Medical and Scientific Advisory Panel that is leading the research on this link. This can then cause symptoms of neurological disorders, such as dementia, to show earlier. Dr Atri, who is the director of Banner Sun Health Research Institute, a large research facility on Alzheimer's disease and other ageing-related disorders in Arizona, told The Straits Times that he has seen some cases where dementia-related changes happened at an unusually fast rate, and these include people who had mild symptoms of Covid-19. More studies will be needed to answer questions, such as whether these symptoms will last or worsen. Dementia is a general term for the impaired ability to remember, think or make decisions that hinders a person's daily life. It results from diseases such as Alzheimer's and injuries that affect the brain, and mainly affects people 65 and above. In Singapore, one in 10 people above the age of 60 suffers from dementia. The syndrome is usually marked by a toxic build-up of proteins in the brain - which can start happening in some people as early as 25 years before they show signs of dementia. Dr Atri said Covid-19 could aggravate this process and hasten cognitive decline, and then dementia. "Let's say I'm in my 50s, and I'm destined to show dementia symptoms in my late 60s, early 70s, and I already have these toxic proteins and some issues going on with it. "Covid-19 may come in and really fan these flames," said Dr Atri. Apart from neurological symptoms associated with Covid-19 like the loss of taste and smell, Dr Atri said those who have long Covid should also be on the lookout for "mental fog, problems with attention and concentration, more effortful mental activities, maybe forgetfulness". There can also be sleep issues and anxiety. More on this topic   Related Story English study finds long Covid affects up to 1 in 7 children months after infection   Related Story 1 in 10 recovered Covid-19 patients in S'pore suffers persistent symptoms six months after infection: Study This is another reason why people should be vaccinated, he said. In July, a study led by Singapore's National Centre for Infectious Diseases (NCID) found that one in 10 recovered Covid-19 patients here had persistent symptoms six months after the initial infection. NCID is currently exploring the long-term neuropsychological and cognitive effects of Covid-19 in people who had mild to severe Covid-19. This study is being done with Nanyang Technological University's Lee Kong Chian School of Medicine and the National Neuroscience Institute, and results are expected next year. Dr Barnaby Young, a consultant at NCID, said some Covid-19 patients experience brain fog, fatigue and insomnia, though they "typically recover with time and most people will not have long-term consequences". Associate Professor Philip Yap, a senior consultant at Khoo Teck Puat Hospital's geriatric medicine department, pointed out a recent study published in July in eClinical Medicine, which followed up with 3,762 patients from 56 countries. Seven months after having Covid-19, cognitive dysfunction was revealed to be one of the most common symptoms. This could have been caused by inflammation in the brain, compromised blood flow, especially in small vessels of the brain, and changes in the immune system. "Given the large number of patients with Covid-19, increased vulnerability of old persons to both Covid-19 and dementia, and observations of cognitive symptoms post-Covid, there is concern that Covid-19 can accelerate cognitive decline and increase the prevalence of cognitive dysfunction and subsequent dementia in the years to come," said Prof Yap. More on this topic   Related Story Half of Covid-19 patients had lingering symptoms one year later   Related Story Covid-19's long tail: What is it and why does it happen? More research over a longer period of time will hopefully provide more clarity on this, he said. Dr Young noted that "older and frail adults who have a severe Covid-19 infection may develop a stroke, inflammation of the cerebral blood vessels and other neurological complications" - another reason why it is so important this group is vaccinated. Prof Yap added: "In Singapore, our aim is to keep the number of infections low - especially among older, vulnerable people - to limit the impact on our population, if any. If we can keep the number of infections low, then hopefully its impact will not be too significant."

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Adlai Nortye Announces First Patient Dosed in Phase Ia Clinical Trial of AN2025 and AN0025 in Combination with atezolizumab for Advanced Solid Tumors

NEW JERSEY, the U.S. and HANGZHOU, China, Sep 8, 2021 - (ACN Newswire via SEAPRWire.com) - Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, today announced that the first patient has been dosed in the Phase Ia clinical trial in the U.S. to evaluate the triple combination of AN2025 (buparlisib, oral pan-PI3K inhibitor), AN0025 (oral EP4 antagonist) and atezolizumab (PD-L1 inhibitor) in patients with locally advanced/metastatic tumors.This trial (AN2025S0101) is an open-label, multicenter, Phase Ia study to evaluate the safety, tolerability, pharmacokinetics ("PK") and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with atezolizumab in patients with locally advanced/metastatic tumors. The study consists of three dose-limiting toxicity ("DLT") Observation Periods, Observation I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. Each Observation period will last 3 weeks. This study plans to recruit approximately 63 patients. The first patient was dosed at Florida Cancer Specialists - Lake Mary Cancer Center, while the study is also going to recruit patients from the University of Colorado Cancer Center, Rutgers Cancer Institute of New Jersey and Stephenson Cancer Center in Oklahoma.AN2025 targets not only PI3K mediated tumorigenesis (e.g. via inhibition of PI3Ka/PIK3CA mutants) but also the immunosuppression of the tumor microenvironment (e.g. via inhibition of PI3Ko and PI3Ky). According to the Frost & Sullivan Report, PIK3CA alterations are found in approximately 13% of all solid tumors globally, including 25% to 40% of cervical cancer, 30% to 40% of breast cancer, 30% to 35% of endometrial cancer, 30% of ovarian cancer, 24% of urothelial cancer, 20% of colorectal cancer and 10% to 20% of head and neck squamous cell carcinoma ("HNSCC") globally. The global incidence of PIK3CA mutant solid tumors reached approximately 2.3 million in 2020 and is expected to reach approximately 2.9 million in 2030, indicating a substantial overall addressable market and significant commercial potential.Adlai Nortye aspires to develop differentiated cancer immunotherapy medicines for global markets. The Company's Cocktail therapy strategy represents the third wave of immuno-oncology therapy, featuring the combination of an immune checkpoint inhibitor with two or more additional cancer therapies. The Company expects it to achieve significantly higher overall response rates than present combination therapies. The triple combination of AN2025 (targeted therapy), AN0025 (immuno-oncology therapy) and atezolizumab (immuno-oncology therapy) exemplifies the cocktail therapy strategy of Adlai Nortye."Results from preclinical studies of the triple combination of AN2025, AN0025 and an anti-PD1 antibody have demonstrated encouraging antitumor activity. We believe that this triple combination potentially could develop into a novel anti-cancer immune therapy by exquisitely and systemically targeting the suppressive tumor microenvironment and thus permitting enhanced host immune responses against the tumor." said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye, "We expect to identify the recommended Phase II dose of this Phase I clinical trial in the second half of 2022 as a step in a planned development program to bring this therapy to patients worldwide. Adlai Nortye is strongly committed to improve the lives of patients and their families by continuously developing our pipeline in oncology through our cocktail therapy strategy."About AN2025S0101This is an open-label, multicenter, Phase Ia study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods, Observation I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. Each Observation period will last 3 weeks.About AN2025 (Buparlisib)AN2025 (buparlisib) is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global randomized Phase II clinical trial for the treatment of recurrent or metastatic HNSCC with buparlisib in combination with paclitaxel, the median overall survival was as high as 10.4 months. Buparlisib was granted Fast-Track designation for this indication from the FDA. The ongoing study is the first global Phase III clinical trial conducted by Adlai Nortye.About AN0025 (EP4 Antagonist)AN0025 is a potentially first-in-class oral EP4 antagonist that blocks prostaglandin E2 from binding to its subtype 4 receptor (EP4) changing the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors in combination with radiotherapy/chemoradiotherapy ("RT/CRT"). A Phase Ib study of AN0025 in combination with the standard of care in a neoadjuvant setting for locally advanced rectal cancer showed excellent results, with 20% of patients achieving clinical complete remission and 16% achieving pathological complete remission in this study.About Adlai NortyeAdlai Nortye is a global biopharmaceutical company focused on developing innovative oncology drugs, with its R&D and clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, four of them are being investigated in clinical trials. With fast-track designation from the FDA, AN2025 (buparlisib), in combination with paclitaxel, is initially developed to be the drug of choice for 2L treatment of metastatic HNSCC after anti-PD-1 treatment (Phase III multi-center clinical trial). AN0025 is a clinical-stage, potential first-in-class EP4 antagonist designed to modulate tumor microenvironment. AN1004 (pelareorep), with fast-track designation from the FDA, is a registrational trial-stage, potential first-in-class intravenously delivered oncolytic virus for treating hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. AN4005, the Company's clinically most advanced drug candidate from in-house discovery, is a potential first-in-class, orally available, small-molecule PD-L1 inhibitor.The Company has assembled an experienced management team, built its proprietary drug research and development platforms and partnered with multiple leading pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: www.adlainortye.com. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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