Posted on

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

TOKYO, Mar 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) is ongoing.The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time. Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022. In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.About the Prior Assessment Consultation SystemThe prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- Aβ antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017. * Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD. About Eisai Co., Ltd.Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com. About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.Biogen Safe HarborThis news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

HONG KONG, Feb 7, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 21 January 2022, an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China (the "NMPA"). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of multiple sclerosis.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "after the Company announced earlier the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03, an IND application (for multiple sclerosis) for SN1011 has been filed with and accepted by the Center for the CDE of the NMPA, which will accelerate the progression of the Phase II clinical study and clinical development program related to indication for treatment of multiple sclerosis, fully reflecting the Company's efficient implementation of new drug R&D programs. We are absolutely confident in the enormous prospects of SN1011's clinical development. In the future, the Company will accelerate the program to further expand its product pipeline and strive to bring benefits to patients."About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Eisai’s Anti-amyloid Beta Protofibril Antibody Lecanemab Selected as the Background Therapy for the Tau Nexgen Study

TOKYO, Jan 19, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study). The study will assess the effect of Eisai's investigational anti-microtubule binding region (MTBR) tau antibody E2814, in dominantly inherited Alzheimer's disease (DIAD).People who have genetic mutations of DIAD are known to develop Alzheimer's disease (AD) and will likely develop symptoms at around the same age their affected parents did, often in their 50s, 40s or even 30s. The major AD pathologies are amyloid plaque that consists of amyloid beta (Abeta) aggregates; neurofibrillary tangles; and intraneuronal aggregates of tau, all of which are believed to spread throughout the brain.The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in pre-symptomatic or symptomatic participants who have an AD-causing gene mutation. In March 2021, the DIAN-TU selected E2814, which was created from a research collaboration between Eisai and University College London, as the first investigational medicine among anti-tau drugs for the Tau NexGen study. With increasing evidence from clinical studies showing that targeting amyloid can reduce biomarkers of AD, the Tau NexGen clinical trial leaders selected Eisai's investigational anti-Abeta protofibril antibody lecanemab (BAN2401) as the background anti-amyloid therapy, and the study design was amended in November 2021.Eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of novel medicines based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of affected individuals and their families in diseases with high unmet needs, such as dementia including AD.About Dominantly Inherited Alzheimer Network (DIAN)The DIAN is an international research effort focused on dominantly inherited Alzheimer's disease. Dominantly Inherited Alzheimer's disease (DIAD) is a rare form of Alzheimer's disease (AD) that causes memory loss and dementia in individuals -- typically while they are in their 30s to 50s. The disease affects less than 1% of the total population of people with AD. The aim of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) is to find solutions to treat or prevent this disease and, potentially, all forms of Alzheimer's. The DIAN-TU is an international public-private partnership dedicated to designing and managing interventional therapeutic trials for individuals with and at risk of DIAD.About Tau NexGen studyThe purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in people who have an AD-causing gene mutation. In the Tau NexGen study, symptomatic participants will be administered anti-amyloid beta (Abeta) protofibril antibody lecanemab for six months before being randomly assigned to also receive the anti-tau drug or a placebo. Since amyloid plaques accumulate before tau tangles in AD, this study design allows the researchers to assess whether amyloid removal clears the way for the anti-tau drug to function most effectively. Pre-symptomatic participants will be randomly assigned to receive the anti-tau drug or a placebo for a year before beginning lecanemab administration. By staggering the drugs in this way, the researchers will be able to evaluate the effects of the anti-tau drug alone before assessing the effects of the two drugs together. If the primary and secondary endpoints are positive in the analysis two years after the start of study, the study will be extended for another two years to assess whether the drug slows cognitive decline and has further effects on tau pathology.About E2814An investigational anti-microtubule binding region (MTBR) tau antibody, E2814 is being developed as a disease modifying agent for tauopathies including sporadic AD. Phase I clinical studies are underway. E2814 was discovered as part of the research collaboration between Eisai and University College London. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for AD that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurodegenerative process.in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (PEisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017. Currently, lecanemab is being studied in a pivotal Phase III clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase II clinical study ( Study 201). In July 2020 the Phase III clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, was initiated. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai.In September 2021, a rolling submission to the FDA of a Biologics License Application (BLA) for the treatment of early AD under the accelerated approval pathway was initiated. Lecanemab was granted Breakthrough Therapy designation in June 2021, a U.S. Food and Drug Administration (FDA) program intended to expedite the development and review of medicines for serious or life-threatening conditions.* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini- Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placeboMedia Inquiries:Public Relations Department, Eisai Co., Ltd.+81-(0)3-3817-5120Eisai Inc (U.S.) Libby Holman 201-753-1945Libby_Holman@eisai.comInvestor Contact:Eisai Co., Ltd.Investor Relations Department TEL: +81-(0)70-8688-9685 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

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)

Read More
Posted on

Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation

TOKYO, Dec 24, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early Alzheimer's disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA. In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License application (BLA) for lecanemab under the accelerated approval pathway. The BLA is primarily based on clinical, biomarker and safety data from the Phase 2b clinical study (Study 201) in people with early AD and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted. The lecanemab Phase 2b study results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. The lecanemab Clarity AD Phase 3 clinical study in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD is included to support the ongoing rolling submission. Another Phase 3 clinical study, AHEAD 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. Additionally, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Alzheimer's Disease is a serious, progressive and devastating disease with few treatment options. Eisai and Biogen are committed to bring new treatment options to people living with early AD, their families and healthcare professionals who are waiting for them as early as possible. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Registration for Covid-19 vaccination trial for children has now closed, study will begin soon: KKH

SINGAPORE - Registration for a trial to determine how children aged five to 11 respond to Covid-19 vaccination has now concluded, and the study will begin "as soon as everything is in place", said the KK Women's and Children's Hospital (KKH) on Saturday (Nov 20). Dr Yung Chee Fu, a senior consultant from the infectious disease service at the KKH's Department of Paediatrics said in response to queries from The Straits Times that it is targeting 150 participants aged between five and 11 for this research study, and the children will be followed for about 15 months. The study, which is backed by the Ministry of Health, is aimed at assessing the safety and immune responses among children who receive the Covid-19 vaccines, and to "evaluate operational logistics" from rolling out the vaccine at scale. "The data will help inform and guide public health vaccination policy for young children in Singapore...We have seen a very encouraging response from parents and caregivers," said Dr Yung. He added that the study aimed to recruit children who were healthy, and did not have any previous Covid-19 infection or are considered to be "highly immunosuppressed" from cancer or chemotherapy. Participants with certain underlying but well-controlled medical conditions such as asthma or eczema were welcome to participate, said Dr Yang. Children who are assessed to be eligible for the trial will receive two paediatric vaccine doses of the Pfizer vaccine, three weeks apart. The paediatric doses are about one third of the adult vaccine, though they are made of a different formulation from the regular one. For instance, while the paediatric doses use the same mRNA ingredient as the adult vaccine, a different buffer solution is used so that it can be stored under more conventional cold chain requirements. "The child will need to have his or her blood taken at various time-points over 15 months. This is needed to help us ascertain the antibody levels and immune responses in the participant," he added. Participants will also complete a seven-day vaccine diary to assess any side effects. Side effects for children are similar to that of adults, which include injection site pain, fatigue, rash, headache, and fever, which will generally resolve on their own within a few days, said Dr Yung. "These side effects are normal signs that your body is building protection or immunity," he added. In line with MOH's guidance for adolescents and young people, children are also advised to avoid strenuous activities for two weeks post-vaccination. The vaccinations will be administered at the vaccination centre at KKH, which is set up and equipped to manage medical emergencies, he added. More on this topic   Related Story New supply agreement inked with Pfizer for Covid-19 vaccines for kids   Related Story More data needed before kids in S'pore get Covid-19 vaccine   Related Stories:  Related Story Pfizer or Moderna booster - which is more effective? Here's what an MOH study shows Related Story Covid-19 Delta variant dominates the world, but scientists watch for worrisome offspring Related Story Living with Covid-19: Coming to grips with our anger and angst Related Story Living with uncertainty: The price of zero-Covid in China Related Story How various countries charge patients for Covid-19 treatments Related Story Why don't we have a Covid-19 vaccine for pets? Related Story Germany's fourth Covid-19 wave: 'A pandemic of the unvaccinated' Related Story How does an elite athlete's body react to Covid-19? Related Story Mind over matter? Long Covid study sparks controversy Related Story Why do more men die of Covid-19?

Read More
Posted on

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer’s Disease (CTAD) Conference

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer's Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months. The primary endpoint was Bayesian analysis of 12-month clinical change on ADCOMS with the goal to identify the most efficacious dose (ED90 dose). Primary analysis was super-superiority over placebo by ≥25%: goal was 80% probability of >/=25% reduction in decline versus placebo. Study achieved the goal of identifying smallest dose that achieved ≥90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. At 12 months, ED90 dose had 64% probability of being super-superior to placebo by 25% reduction. At 12 months, ED90 dose had 98% probability superior to placebo. Consistent treatment effect was observed at 18 months for ADCOMS (29% to 37%), CDR-SB (26.5% to 35%), and ADAS-Cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses. "In Study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints. This sensitivity analysis shows lecanemab clinical efficacy results across statistical models are consistent, reliable and further enhances our confidence in the clinical potential of this investigational therapy," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Through our comprehensive research program, we will continue to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical AD. In March 2021, Eisai completed enrollment of 1,795 patients with early Alzheimer's disease in our confirmatory Phase 3 Clarity AD clinical study. The Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab's safety and efficacy in individuals with preclinical AD." This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit https://www.eisai.com/news/2021/news202187.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Eisai: Introduction of Plasma-based Biomarker Screening to Facilitate Identification of Subjects for Phase 3 Ahead 3-45 Trial Presented at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced a presentation about exploring the use of plasma-based biomarkers in the Phase 3 AHEAD 3-45 study of lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody. AHEAD 3-45 is the first preclinical Alzheimer's disease (AD) trial to use these biomarkers to detect AD pathology and potentially accelerate the screening process. This presentation was made by The Alzheimer's Clinical Trial Consortium (ACTC) at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually. The AHEAD 3-45 clinical study will evaluate the efficacy of treatment with lecanemab in participants with preclinical AD and elevated amyloid and in participants with early preclinical AD and intermediate amyloid. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. The Phase 3 AHEAD 3-45 study consists of two sister trials (A3 and A45) with specific dosing regimens tailored to baseline brain amyloid levels on screening PET scans for intermediate amyloid in A3 and for elevated amyloid in A45. In a first-of-a-kind approach in a preclinical trial for AD, the study will seek to determine the potential role of plasma-based biomarkers in the identification of cognitively unimpaired individuals most appropriate to move on to PET imaging, which is currently the standard of care to determine treatment approach. Blood samples will be collected at a brief initial visit to determine the Abeta42/40 ratio, which has previously been shown to be a potentially reliable predictor of brain amyloid level and is used to determine eligibility to proceed to PET imaging. Based on the PET imaging results, the participants are grouped into A3 or A45 trials. As of October 18, 2021, data from 659 participants was available for analysis. Adjusted Abeta42/40 ratio demonstrated very good ability to predict amyloid PET eligibility (AUC of 0.87) suggesting plasma screening has potential to substantially reduce number of PET scans needed to fully enroll A3 and A45. "The screening process for AD can be time consuming and costly. There is a need to accelerate and improve the efficiency of identifying individuals who may be eligible for current and future AD treatments based on cognitive testing and confirmation of elevated amyloid in the brain," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Eisai is forging new ground by incorporating plasma screening in a clinical study for individuals with preclinical AD. We are optimistic that this novel approach will help identify people with elevated brain amyloid, and reduce the need for diagnostic amyloid PET scans or spinal taps." This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit https://www.eisai.com/news/2021/news202186.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Eisai: DIAN-TU Selects Lecanemab as Background Anti-Amyloid Therapy in Clinical Trial Evaluating Investigational Therapy Targeting Tau for Dominantly Inherited Alzheimer’s Disease

TOKYO, Nov 9, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has an agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical study (Tau NexGen) design to include a background anti-amyloid agent. The Tau NexGen clinical study was originally designed to focus on therapies that target tau. With increasing evidence from clinical studies showing that targeting amyloid can reduce biomarkers of Alzheimer's disease (AD), the Tau NexGen clinical trial leaders selected Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab as the background anti-amyloid agent. The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in people who have an Alzheimer's disease-causing gene mutation. The study will evaluate if treatment with study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers. People who have this genetic mutation of dominantly inherited Alzheimer's disease (DIAD) are known to develop AD and will likely develop symptoms at around the same age their affected parents did, often in their 50s, 40s or even 30s. In March 2021, the DIAN-TU selected anti-microtubule binding region (MTBR) tau antibody E2814, which was created from collaboration research between Eisai and University College London, as the first investigational medicine among anti-tau drugs for the DIAN-TU tau study. In the amended Tau NexGen study, symptomatic participants will be administered lecanemab for six months before being randomly assigned to also receive the anti-tau drug or a placebo. Since amyloid plaques accumulate before tau tangles in AD, this study design allows the researchers to assess whether amyloid removal clears the way for the anti-tau drug to function most effectively. Pre-symptomatic participants will be randomly assigned to receive the anti-tau drug or a placebo for a year before beginning lecanemab administration. By staggering the drugs in this way, the researchers will be able to evaluate the effects of the anti-tau drug alone before assessing the effects of the two drugs together. The primary endpoint is a slowing of tau accumulation in the brain in symptomatic participants, as seen on PET brain scans. As a secondary endpoint, the researchers will evaluate whether the investigational therapies affect levels of a specific kind of tau -- phosphorylated tau 217 -- in the cerebrospinal fluid of pre-symptomatic participants. If these primary and secondary endpoints are positive in the analysis two years after the start of study, the study will be extended for another two years to assess whether the drug slows cognitive decline and has further effects on tau pathology. "With growing evidence that removing amyloid plaques has biologically beneficial effects on amyloid and tau, we believe that targeting both Alzheimer's disease pathologies -- amyloid plaques and tau tangles -- at the same time can provide the highest chance of success," said principal investigator Randall J. Bateman, M.D., director of DIAN-TU and the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University. "Eisai's anti-MTBR tau antibody E2814 was chosen as the first investigational therapy among anti-tau drugs for the groundbreaking Dominantly Inherited Alzheimer Network Trials Unit Tau NexGen, which was originally designed to target tau proteins. The growing body of evidence suggesting the removal of amyloid plaque slows cognitive decline is creating new possibilities to potentially fight this devastating disease. Eisai is proud that our investigational anti-amyloid beta protofibril antibody lecanemab has been selected as the background anti-amyloid agent in this arm of the study," said Lynn Kramer, M.D., FAAN, Chief Clinical Officer, Neurology Business Group, Eisai Co., Ltd. "In our Phase 2b study, lecanemab 10 mg/kg biweekly dosing without titration, demonstrated robust clearance of the brain amyloid plaques from early stage of administration and slowed cognitive decline in people living with early AD. Encouragingly, the rate of amyloid-related imaging abnormalities-edema/effusion for this same dosing was 9.9% with less than 2% being symptomatic." Eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of novel medicines based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of affected individuals and their families in diseases with high unmet needs, such as dementia including AD. Our vision is clear: a world free of neurodegeneration. About Dominantly Inherited Alzheimer Network (DIAN)The DIAN is an international research effort focused on dominantly inherited Alzheimer's disease. Dominantly Inherited Alzheimer's disease (DIAD) is a rare form of AD that causes memory loss and dementia in individuals -- typically while they are in their 30s to 50s. The disease affects less than 1% of the total population of people with Alzheimer's. The aim of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) is to find solutions to treat or prevent this disease and, potentially, all forms of Alzheimer's. The DIAN-TU is an international public-private partnership dedicated to designing and managing interventional therapeutic trials for individuals with and at risk of DIAD. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Abeta) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017. Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase 2 clinical study (Study 201). In July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, was initiated. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai. In September 2021, a rolling submission to the FDA of a Biologics License Application (BLA) for the treatment of early AD under the accelerated approval pathway was initiated. Lecanemab was granted Breakthrough Therapy designation in June 2021, a U.S. Food and Drug Administration (FDA) program intended to expedite the development and review of medicines for serious or life-threatening conditions. About E2814An investigational anti-microtubule binding region (MTBR) tau antibody, E2814 is being developed as a disease modifying agent for tauopathies including sporadic AD. Phase I clinical studies are underway. E2814 was discovered as part of the research collaboration between Eisai and University College London. E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placeboMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Eisai Inc (U.S.)Libby Holman201-753-1945Libby_Holman@eisai.com Investor Contact:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)70-8688-9685 Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

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)

Read More
Posted on

New S’pore institute to study local, regional plants for health, medical advancements

SINGAPORE - A new research institute was launched here on Friday (Sept 17) to drive advancements in the biological, health and pharmacological sciences through the study of plants and natural ecosystems. The SingHealth Duke-NUS Institute of Biodiversity Medicine (BD-Med) will study various aspects of local and regional plant biodiversity to identify any potential for novel medicinal and scientific applications. For example, studies could look into identifying plant compounds to accelerate drug discovery, or manipulating a plant's biology to enhance its nutritional quality, said Professor Ivy Ng, who is group chief executive of SingHealth. The institute was launched by Deputy Prime Minister Heng Swee Keat at the SingHealth Duke-NUS Scientific Congress 2021, a two-day virtual event on the theme of revolutionising medicine. "In Singapore, we are in a unique position to explore biodiversity medicine. Our biodiversity is rich, with over 4,000 local flora species and cultivars," Mr Heng said. "We also have a long history of imbuing the city with nature. We have carefully nurtured a biophilic city in a garden." BD-Med will focus on three specific research programmes, backed by partnerships with local and regional scientific, innovation and environmental agencies. The Herbal Biodiversity and Medicine programme will use new technologies to extract and study plant components that may have the potential to fight common diseases such as diabetes and hypertension. The Food Biodiversity and Nutrition programme will look into the concept of food as medicine, or the approach of using food to manage diseases alongside conventional medical treatment. It will also study nutrient-dense and sustainable food alternatives to boost food supply and security. The Urban Biodiversity and Wellness programme will study the effects of biodiversity on the living environment as well as its ability to promote wellness, including mental health. It will examine how a plant's biology, appearance, colour and smell affect a person's health, such as in the use of essential oils to treat anxiety and insomnia. Professor Teh Bin Tean, who is vice-chair of research for the Oncology Academic Clinical Programme at Duke-NUS Medical School, will serve as the new institute's director. He said: "Tapping the wealth of biodiversity in South-east Asia and Singapore, my team and I hope to delve deep into studying the genetic make-up, nutritional and medicinal benefits of local and regional plants to better understand, prevent and fight diseases, and even contribute to environmental and food sustainability." BD-Med's work will also include developing about 12,000 sq m of garden space spread across four hospitals under the SingHealth cluster - Singapore General Hospital, KK Women's and Children's Hospital, Changi General Hospital and Sengkang General Hospital - to grow and study various regional plant species. These spaces will house herbal gardens and aquaponic systems, and will double as green spaces that can bring respite to patients and staff. More on this topic   Related Story Singapore scientists uncover secret of the black rot in vegetable crops   Related Story Study finds anti-cancer properties in local plants To commemorate the launch, scientists from BD-Med and the Agency for Science, Technology and Research's Genome Institute of Singapore jointly announced that they had successfully sequenced the genome of Singapore's national flower, the Vanda Miss Joaquim orchid. Understanding the orchid's genetic make-up could help make the breeding of other orchid hybrids more efficient, Prof Teh said, adding that further research may also uncover potential therapeutic applications for health and wellness. "This study shows the possibilities of harnessing the insights and knowledge from local and regional plant biodiversity studies for applications in science and medicine," he said. At the event's opening ceremony on Friday, philanthropist Vincent Cheng, chairman of the Hong Kong-based Verdant Foundation, presented BD-Med's leaders a cheque for $5 million as a gift to support the institute's work. More on this topic   Related Story New nursery for coastal trees launched on Pulau Ubin to help restore island's shores   Related Story Transforming Singapore into a City in Nature

Read More
Posted on

SinoMab, Sinovent and Everest Medicines Announce Licensing Agreement for Global Development and Commercialization of A Next-Generation BTK Inhibitor in Renal Diseases

HONG KONG, Sep 17, 2021 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited (HKEX 3681.HK, "SinoMab") announced with Suzhou Sinovent Pharmaceuticals Co., Ltd. ("Sinovent") today that they have entered into an exclusive licensing agreement with Everest Medicines (HKEX 1952.HK, "Everest") to out-license the right to develop and commercialize SN1011 (referred as "XNW1011" by Sinovent), a covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, to Everest globally for the treatment of renal diseases. Under the terms of the agreement, SinoMab and Sinovent will receive USD $12 million in initial upfront payments from Everest and up to $549 million as future development, regulatory, and commercial milestone payments, as well as high single-digit to low double-digit royalties on global net sales.SN1011 is a next-generation covalent reversible BTK inhibitor that exhibits high selectivity, excellent pharmacokinetics property, robust target engagement and a safety profile that supports continued development based in part on results from a completed Phase 1 study with healthy subjects conducted by SinoMab in China. This Phase I clinical trial is to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in the treatment of autoimmune disease. In this study, 71 healthy subjects were enrolled, and the highest dosage was ascended to 800 mg in single ascending study and 600 mg in multiple ascending study. None of the subjects reported serious adverse event (SAE). SN1011 is well tolerated with an excellent safety profile. Clinical study report is expected to be released by the end of the third quarter of this year. Following the approval of Investigational New Drug (IND) applications of SN1011 for pemphigus vulgar (PV) and systemic lupus erythematosus (SLE), SinoMab is initiating a Phase II clinical study targeting PV in China. The Company also plans to initiate a Phase II clinical study targeting SLE in near future.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said, "Since our listing, SinoMab has been actively exploring and identifying opportunities for collaboration and partnership, including but not limiting to in-license and out-license of preclinical and clinical assets, to further strengthen our pipeline and expand our global presence. The out-license of SN1011 is a key milestone in our business development efforts. Alliance with Everest is not only recognition of the potential of SN1011, but also demonstration of the strength and rapid advancement of our pipeline.". About BTK InhibitorBruton's tyrosine kinase (BTK) is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. About SinoventSinovent is a global biopharmaceutical company focused on discovery, development, and commercialization of innovative medicines to address significant unmet clinical needs. Headquartered in Suzhou, China, the Company has established a highly efficient, fully integrated global R&D organization with presence in China, US and Australia. Leveraging our scientific expertise and proprietary discovery platforms, Sinovent has developed a robust and balanced pipeline, which consists of five first-in-class or best-in-class clinical programs, and many more preclinical programs. The Company's diseases areas of focus include oncology, metabolic and infectious diseases. For more information, please visit its website at www.sinovent.com.cnAbout Everest MedicinesEverest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.comAbout SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, pemphigus vulgar, non-Hodgkin's lymphoma, asthma, and other diseases with major unmet clinical needs. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Toyota: Feasibility Study on the Receiving and Distribution Business of Imported Hydrogen in Chubu Regio

Toyota City, Japan, Aug 6, 2021 - (JCN Newswire via SEAPRWire.com) - Sumitomo Corporation, Chiyoda Corporation, Toyota Motor Corporation, Japan Research Institute, Limited, and Sumitomo Mitsui Banking Corporation (collectively, "Joint Contractors") have been appointed by the New Energy and Industrial Technology Development Organization ("NEDO") to conduct a feasibility study on the receiving and distribution business of hydrogen in Chubu Region ("Study"). NEDO selected the Joint Contractors in the public offeriing for "Development of Technologies for Realizing a Hydrogen Society/Regional Hydrogen Utilization Technology Development/Hydrogen Production and Utilization Potential Research" and the Study is scheduled to be conducted during FY2021 and FY2022.In order to promote the utilization of hydrogen in Japan, it is essential not only to produce hydrogen domestically, but also to import large volumes of hydrogen from cost competitive areas. To materialize large volume of imports, it is important to build supply chains from import terminals to demand locations, and to put priority on identifying challenges and find its solutions.Building on the previous study of potential hydrogen demand in Chubu region by the Hydrogen Utilization Study Group ("Study Group") conducted in February 2021, this Study will focus on developing a large-scale hydrogen supply chain. The Study will also address the economic viability of the large-scale receving and distribution business and sort out financial, technical and regulatory challenges for commercialization assuming that hydrogen is imported in the Chubu region.Iwatani Corporation, Chubu Electric Power Co., Inc., Toho Gas Co., Ltd., Air Liquide Japan G.K., and Mitsubishi Chemical Corporation (collectively "Cooperation Companies"), as a member of Chubu Hydrogen Utilization, and Joint Contractors have formed the consortium to complete this Study. And also cooperation of other member companies in the Study Group (Idemitsu Kosan Co., Ltd., ENEOS Corporation, Kawasaki Heavy Industries, Ltd., JFE Engineering Corporation, Nippon Steel Corporation) is expected to deepen the Study.To achieve the Study Group's goal, "Social implementation of hydrogen in Chubu Region in 2025" in line with carbon neutrality in Japan in 2050, further progress toward FEED (Front End Engineering Design) stage will be considered with the completion of this Study. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab (BAN2401)

TOKYO, Jul 30, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) -- granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 -- following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer's disease (AD) (Mild Cognitive Impairment [MCI] due to AD and mild AD) at the Alzheimer's Association International Conference (AAIC) held in Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.: 57780).Lecanemab Study 201 and OLELecanemab is an investigational humanized monoclonal antibody that preferentially binds to soluble amyloid- beta (Aβ) aggregates (protofibrils). Lecanemab reduced brain Aβ and slowed clinical decline in an 18-month Phase 2b proof of concept study (Study 201, n=856) in early AD (Alz Res Therapy 13; 2021). After analysis of the core study, there was an off-treatment gap period of 9-59 months (period of time between the last dose of lecanemab in the core and the OLE baseline; average of 24 months). After this off-treatment gap, the OLE evaluating the 10 mg/kg IV biweekly lecanemab dosing was implemented (n=180 from core study enrolled). The clinical effect of treatment with lecanemab was assessed via the adjusted mean change of the AD Composite Score (ADCOMS), the primary clinical endpoint of the core study. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment. Additional clinical endpoints included Clinical Dementia Rating-Sum of Boxes (CDR-SB) and AD Assessment Scale - Cognitive Subscale (ADAS- Cog).May suggest a potential disease-modifying effectFor subjects with early AD at Study 201 OLE baseline, the dose-dependent clinical treatment effect of lecanemab administration relative to placebo during the core phase was maintained. While off-treatment during the gap period, people who received 10 mg/kg IV in the core continued to perform better than those who received placebo on ADCOMS. While off-treatment during the gap period, subjects declined at the same rate on key clinical measures in all core treatment groups. The increase in adjusted mean change between the three month follow up after the core 18-month and OLE baseline for lecanemab bi-weekly, lecanemab monthly and placebo dosing respectively were 0.11 (0.07 to 0.18 ), 0.10 (0.12 to 0.22) and 0.09 (0.19 to 0.28) for ADCOMS. Similar results were observed for CDR-SB and ADAS-Cog. This may suggest a potential disease-modifying effect of lecanemab.Potential relationship between the plasma Aβ42/40 ratio, brain amyloid by PET and treatmentLow values of plasma Aβ42/40 ratio is recognized as an indicator of elevated amyloid in the brain, and was assessed in a subset of participants in Study 201.1 The plasma Aβ42/40 ratio increased during the core phase and OLE in those treated with lecanemab and decreased during the gap period, potentially demonstrating the relationship between the plasma Aβ42/40 ratio and treatment with lecanemab. The lecanemab treatment related increases in plasma Aβ42/40 ratio were inversely correlated with treatment related reduction of brain amyloid in the core and OLE (Poster No. 57760).Assessing the long-term effect of continued treatment with lecanemabStudy participants with early AD at the OLE baseline who received placebo during the core phase and were treated for the first time with lecanemab during OLE, as well as those treated with lecanemab both during the core phase and during OLE, showed reduced clinical decline relative to natural disease progression (reference similar population from ADNI). The adjusted mean change from OLE baseline at the end of the 18-month OLE study period for core 10 mg/kg bi-weekly dosing, 10 mg/kg monthly dosing, and placebo groups respectively were 0.102, 0.165 and 0.07 for ADCOMS, all of which showed a slower rate of progression as compared to ADNI (0.214). Similar results were observed for CDR-SB and ADAS-Cog. The results support the concept of increased long-term benefit of continued treatment with lecanemab when initiated in the early AD stage.These preliminary findings are based on limited data and are being further evaluated in the ongoing Phase 3 Clarity AD study for early AD."The findings from the lecanemab Phase 2b OLE study are encouraging as they supply further insights into outcomes with anti-amyloid therapies and we look forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "The unprecedented confluence of medical knowledge, data analytics, and technological advances make it an incredibly exciting time for Alzheimer's research. This combined with Eisai's precision research approach, which is a treatment paradigm based on a person's pathophysiological biomarker profile along the Alzheimer' disease continuum, makes our company uniquely positioned to research and develop new solutions for patients and their families."Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, "The findings from the Open-Label Extension further strengthen our belief in the potential of addressing amyloid beta pathology in Alzheimer's disease. We look forward to our ongoing collaboration with Eisai to study lecanemab and continuing to pioneer to address the high unmet need for Alzheimer's disease patients."The enrollment of 1,795 patients with early AD in the Phase 3 Clarity AD clinical study was completed in March 2021. The study's primary endpoint is expected to be completed by the end of September 2022. The Phase 3 clinical study, AHEAD 3-45, is currently evaluating lecanemab in individuals with preclinical AD.For more information, visit https://www.eisai.com/news/2021/pdf/enews202165pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

TOKYO, Jul 30, 2021 - (JCN Newswire via SEAPRWire.com) - Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer's disease called ICARE AD-US, at the Alzheimer's Association International Conference (AAIC), being held both virtually and in Denver, Colorado from July 26 - 30, 2021. ICARE AD-US, a prospective study of ADUHELMTM (aducanumab-avwa) 100 mg/mL solution for injection, is designed to collect real-world, long-term effectiveness and safety data on ADUHELM. The virtual oral session (#57522) was titled, "ICARE AD-US: design of a prospective, single-arm, multicenter, noninterventional real-world study of aducanumab in United States."ADUHELM 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).ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the U.S. based on the label approved by the U.S. Food and Drug Administration (FDA). The primary objective of the study is to characterize and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in ADUHELM-treated patients. Secondary objectives are related to gaining a better understanding of ADUHELM safety in real-world clinical practice.The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer's disease studies, aiming to enroll at least 16 percent of the trial's expected 6,000 participants from these communities. Alzheimer's disease clinical trials commonly have one to two percent enrollment from these groups, even though Black/African Americans and Latinx people are respectively two and one-and-a-half times more likely than older White Americans to have Alzheimer's disease.The study intends to enroll patients with Alzheimer's disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years."Biogen is committed to both generating new data about ADUHELM and supporting steps to bring adequate representation to this trial and other clinical trials from traditionally underrepresented groups," said Ivana Rubino, Ph.D., U.S. and Global Head of Medical, Alzheimer's Disease at Biogen. "We believe this can help us better understand the safety and effectiveness of treatment in patients with Alzheimer's disease across ethnicities, something that has challenged researchers in this field for decades. The ICARE AD-US study, designed in collaboration with Alzheimer's disease experts, underscores both of these commitments."The ICARE AD-US study is one of three clinical programs designed to generate new data about ADUHELM. The others include EMBARK, the ongoing, Phase 3b re-dosing study for eligible patients previously enrolled in ADUHELM clinical trials, including the PRIME long-term extension, EMERGE and ENGAGE, and the confirmatory Phase 4 trial that is in the process of being designed and will be conducted to verify the clinical benefit of ADUHELM as part of the post-marketing requirements associated with the accelerated approval pathway of ADUHELM in the U.S."The ICARE AD-US study will provide important information on the safety, effectiveness and management of Alzheimer's disease with ADUHELM, the first approved treatment for Alzheimer's disease that targets the amyloid pathway, in the real-world setting across diverse populations," said Harald Hampel, M.D., Ph.D., Vice President, Chief Medical Officer, Neurology Business Group, Eisai Inc. "It is important for Eisai and the larger scientific community to recruit patients of diverse ethnicities for clinical trials to help address health disparities."The presentation on the ICARE AD-US study will be available for 30 days on the AAIC conference website. Biogen will also post the presentation on the investors section of its website at investors.biogen.com.For more information, visit https://www.eisai.com/news/2021/pdf/enews202164pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer’s Disease and Dementia at AAIC 2021

TOKYO, Jul 21, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the company will conduct a total of 11 presentations, including the latest data of the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (development code: BAN2401) for which the U.S. Food and Drug Administration has granted Breakthrough Therapy designation, at the Alzheimer's Association International Conference (AAIC) to be held in Denver, Colorado and virtually from July 26 to 30, 2021.Major presentations regarding lecanemab include oral presentations about the preliminary assessment of the clinical effect of lecanemab following 18 months of treatment in the open-label extension of the Phase 2b proof of concept study (201 study) in subjects with early Alzheimer's disease (AD) and preliminary screening and baseline characteristics of the Phase 3 clinical study, AHEAD 3-45, for preclinical AD will be given. In addition, an oral presentation regarding the design of the clinical study for the investigational MTBR targeted anti-tau antibody E2814, which has been selected by the Dominantly Inherited Alzheimer Network Trials Unit "DIAN-TU" as the first investigational medicine among anti-tau drugs for the DIAN-TU tau study, will be given. A poster presentation will also be given on the results of an in vivo study of E2511, Eisai's in-house discovered and developed investigational novel oral synapse regenerant. A Phase 1 study for E2511 is underway.Additionally, Eisai and Biogen Inc. (Nasdaq: BIIB) will hold a virtual symposium, "Defining the next-generation clinical care pathway for Alzheimer's disease: biological, technological, and healthcare perspectives," focusing on the AD treatment landscape. As the possibilities for treatment development increase, it is critical to transform the AD patient journey from a symptoms-based approach to a clinical care pathway that is guided by next-generation biomarkers and enabled with technology. Rhoda Au, Ph.D, MBA; Jeffrey Cummings, M.D, D.Sc; Soeren Mattke, M.D, D.Sc; and Wiesje van der Flier, Ph.D; four esteemed AD researchers, will review the latest advances and challenges in the integration of biomarkers and emerging digital tools into the larger healthcare ecosystem for AD.Eisai serves as the lead in the co-development of lecanemab, an anti-Aβ protofibril antibody, which is being jointly developed by Eisai and Biogen.Eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of AD and dementia. Eisai strives to create innovative medicines as soon as possible to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, those living with the disease and their families. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Mitsubishi Motors (Thailand) Signs MoU with Eternity Grand Logistics to Do a Pilot Study on Commercial Usage of Compact EVs

TOKYO, Jul 16, 2021 - (JCN Newswire via SEAPRWire.com) - Mitsubishi Motors Corporation (MMC) announced that Mitsubishi Motors Thailand Co., Ltd. (MMTh), MMC's subsidiary in Thailand, has signed a Memorandum of Understanding (MoU) on June 9 with Eternity Grand Logistics Public Co., Ltd. (Eternity), a logistics company of the Hitachi Transport System Group, to conduct a pilot study on commercial viability of compact electric vehicles (EV) in Thailand.Mitsubishi Minicab MiEV Under the terms of the MoU, MMTh will provide one unit of the Mitsubishi Minicab MiEV, a compact commercial EV that is now sold in Japan, for the study, and Eternity will use the vehicle for one year in its logistics operations. The study aims to understand and explore EV commercial applications verifying actual usage data including mileage, charging history and delivery route. "This study will enable us to explore opportunities to apply EVs for commercial applications," said Eiichi Koito, president and CEO of MMTh. "It is a part of our New Environmental Plan Package, and is contributing to the Thai government's electrification initiative. Through this study, we will explore ways to form an environment for EVs." Ryuichi Honda, CEO of Asia Region of Hitachi Transport System (HQ) and chairman of Eternity, said, "As one of the leading players in the logistics industry, we have a responsibility to reduce our carbon footprint while also cutting operational expenses. We are proud to be partnering with one of the leading automotive companies, Mitsubishi Motors, who has the advanced technology and capability to produce high-tech EVs. This study will allow us to understand and obtain more information on the potential introduction of EVs into our operations. It is in-line with our aim to become a responsible corporate citizen at the forefront of industrial and environmental sustainability." MMC plans to improve the Minicab-MiEV, which has established a track record and credibility for 10 years since its launch in Japan, through more experiments abroad, thereby contributing to building an eco-conscious society together with companies in various industries. About Mitsubishi MotorsMitsubishi Motors Corporation (TSE:7211), MMC--a member of the Alliance with Renault and Nissan--, is a global automobile company based in Tokyo, Japan, which has more than 30,000 employees and a global footprint with production facilities in Japan, Thailand, Indonesia, mainland China, the Philippines, Viet Nam and Russia. MMC has a competitive edge in SUVs, pickup trucks and plug-in hybrid electric vehicles, and appeals to ambitious drivers willing to challenge convention and embrace innovation. Since the production of our first vehicle more than a century ago, MMC has been a leader in electrification--launched the i-MiEV - the world's first mass-produced electric vehicle in 2009, followed by the Outlander PHEV - the world's first plug-in hybrid electric SUV in 2013. MMC announced a three-year business plan in July 2020 to introduce more competitive and cutting-edge models, including the Eclipse Cross (PHEV model), the all-new Outlander and the all-new Triton/L200.For more information on MMC, please visit the company's website athttps://www.mitsubishi-motors.com/en/ Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More
Posted on

Football: Fifa to carry out study on holding World Cup every two years

MANCHESTER, ENGLAND (REUTERS) - Fifa will carry out a feasibility study on holding the World Cup and the women's World Cup every two years after backing a proposal at its annual congress on Friday (May 21). The two competitions are currently held every four years but the Saudi Arabian Football Federation (SAFF) put forward a proposal for a study of the impact of switching to every two years. "We believe the future of football is at a critical juncture. The many issues that football has faced have now been further exacerbated by the ongoing pandemic," said SAFF president Yasser Al-Misehal. "It is time to review how the global game is structured and to consider what is best for the future of our sport. This should include whether the current four year cycle remains the optimum basis for how football is managed both from a competition and commercial perspective," he added. Fifa president Gianni Infantino called it an "eloquent and detailed proposal" with 166 national federations voting in favour with 22 voting against. Speaking after the congress, Infantino told reporters that the study would look at the competitions within the context of the review of the overall international match calendar. "It doesn't matter right now what I think, it matters what results the study is coming up with," he said. "We have to go into this study with an open mind... we know about the value of the World Cup believe me, we know as well about the impact that the World Cup can have." But Infantino questioned whether the current system of regular qualifiers throughout a year ahead of a continental championships and World Cups was the best model. "Do we really think this is the right way for football when we are hearing that fans say they want more meaningful games, less meaningless games, all of these points have to be considered. "We will discuss it, we will analyse it but we will, in all discussions, put the sporting element as a priority not the commercial element," he said, saying he knew that holding twice as many World Cups would not mean doubling the revenue. More on this topic   Related Story Football: Ilhan Fandi one of three uncapped players called up for June's World Cup qualifiers   Related Story Football: North Korea pull out of World Cup qualifiers

Read More
Posted on

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

TOKYO, May 7, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd.and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. The first set of applications (a supplemental New Drug Application [sNDA] for LENVIMA and a supplemental Biologics License Application [sBLA] for KEYTRUDA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581). The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on PFS, OS, and ORR data from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data. The FDA has set Prescription Drug User Fee Act (PDUFA) dates, or target action dates, of August 25 and 26, 2021, for the advanced RCC sNDA and sBLA applications, respectively, and September 3, 2021, for the advanced endometrial carcinoma applications."Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications.""We are pleased that the FDA has granted priority review for LENVIMA plus KEYTRUDA--both in advanced renal cell carcinoma and advanced endometrial carcinoma--underscoring the potential significance of the outcomes observed in the CLEAR study (Study 307/KEYNOTE-581) and Study 309/KEYNOTE-775 trials," said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "Many patients are still in need of new and effective therapies, which fuels our commitment to advancing the development of this combination even more. These milestones reinforce our unwavering dedication to helping the patients we aim to serve."The applications in advanced RCC are based on results from the CLEAR study (Study 307/KEYNOTE-581), in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib. These data were presented in February at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.The applications in advanced endometrial carcinoma are based on results from Study 309/KEYNOTE-775, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus chemotherapy (investigator's choice of doxorubicin or paclitaxel), regardless of mismatch repair (MMR) status. These data were presented in March at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer. Study 309/KEYNOTE-775 is the confirmatory trial for Study 111/KEYNOTE-146, which supported the 2019 accelerated approval of the combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was an accelerated approval based on tumor response and durability of response and reviewed under the FDA's Real-Time Oncology Review pilot program and the FDA's Project Orbis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.For more information, visit https://www.eisai.com/news/2021/news202133.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

Read More