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Honda: Toni Bou Wins 15th Consecutive FIM Trial World Championship Title

TOKYO, Sep 20, 2021 - (JCN Newswire via SEAPRWire.com) - HRC (Honda Racing Corporation) contract rider and Honda factory team(1) (Repsol Honda Team) rider Toni Bou has won the 2021 FIM(2) Trial World Championship. He has clinched his 15th consecutive title by winning the final round in Portugal, held on September 18.Toni Bou (Portuguese GP)This year's Trial World Championship is contested over six rounds (nine trials). In the opening double-header round held in June, Bou finished 1st / 2nd. He then won the next round in France, marking his 120th career win in the competition. After the summer break, he was 1st / 3rd in Andorra, won the next round (again in France), and won both trials at the Spanish double-header. Going in to the final round at Portugal as championship favorite, Bou won the round giving him his 15th consecutive championship title.Since clinching his first world championship title in 2007 on HRC's Montesa COTA 4RT factory bike, Bou has increased his unparalleled consecutive championship titles to 15. He has also won his 14th consecutive X Trial World Championship, an indoor competition raced on artificially prepared sections, taking his total tally of championship titles to 29.Toni Bou | Repsol Honda Team"This year has been very special for me because at the beginning things were very complicated with the injury just a month before the start of the championship. In the end there will come a year when I will not be able to win - I've won for 15 consecutive years - but the fact that I got injured just before the start of the world championship made it special and I didn't want to lose a championship in this way. Once again we battled 100%, I tried to get into shape as the championship progressed and the fact that I had a very good work rate before I got injured also helped me to recover faster. I am very happy to be able to win another world championship. Once again, many thanks to the whole team.Today was also a very special day for everyone as it was Fujinami's last trial. It is very difficult to think of Team HRC without him. I wish him all the best for the future."Shinya Wakabayashi | Honda Racing Corporation President"I would like to congratulate Toni on winning his unprecedented 15th Trial World Championship title. The championship schedule has been severely affected in 2020 and 2021 due to the coronavirus pandemic. To win under such circumstances requires maintaining peak level skills along with physical and mental strength, which Toni has done with flying colors, earning him the highest of praise. I would also like to extend my deepest gratitude to the team who made his victory a reality, and our sponsors for their unwavering support of our motorsports activities. Last but not least by any means, I would like to thank Trial fans worldwide for their passionate support."(1) Factory team:Racing team managed by the bike manufacturer. For Honda, Honda Racing Corporation (HRC) manages its factory teams.(2) FIM: Federation Internationale de MotocyclismeFor more information, visit https://global.honda/newsroom/news/2021/2210919eng.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Honda: Takahisa Fujinami to End 26-Year Trial World Championship Career

TOKYO, Sep 15, 2021 - (JCN Newswire via SEAPRWire.com) - Honda announced that Honda Racing Corporation (HRC) contract rider Takahisa Fujinami (Repsol Honda Team), the first Japanese rider to win the FIM* Trial World Championship in 2004, will be retiring from the championship at the end of this season. Honda is truly grateful for all of the support given to the Japanese rider throughout his career.Born 1980 in Mie, Japan, 41-year-old Takahisa Fujinami began riding motocross at age 3, and after experiencing bicycle trials, started competing in the All Japan Trial Championship at age 13 in 1993, in which he became the youngest champion at age 15 in 1995.The following year, he began his career on the world championship stage, winning his first trial in the 1997 German round, becoming the youngest world championship trial winner at 17 years and 237 days old. In 1998 he was ranked fifth overall, and from the next year to 2003, was ranked second for five consecutive years. In 2004 he became the first Japanese champion in the series. From there on to 2017, he has been in the top five for 21 consecutive years, an astounding record. In the 2021 season-opener in Italy, he won Day 2, not only his fist victory in five years, but a record for the oldest rider to win at 41 years and 151 days old. TrialGP Portugal this weekend will mark Fujinami's 355th and final trial.* FIM: Federation Internationale de MotocyclismeTakahisa Fujinami | Repsol Honda Team"I firmly believe that the time has come to close the curtain on my career as a world trial championship rider after 26 years in the competition. Thanks to everyone's support, over this period, I have been able to make trial my profession and perform at a more than satisfactory level for over a quarter of a century. Thank you very much.They have been 26 great years. And I have to also thank my family, who supported me from the first moment, my team-mates, the brand, the sponsors and also the fans who have cheered me on throughout. I would like to greet each of my fans one by one, and I hope to do it someday, to thank them for the enormous support they have given throughout this time.Honda Racing and Montesa-Honda gave me a bike to participate in the world championship when I was 16 years old and, since then, I am proud to have battled with this team right through to the very end.I still remember the shouts and applause of support at my debut in Japan and also in Spain: 'Fujigas' was born there! The first victory in Germany, the tough, complicated years, but also the joy of the world title in 2004. It's a long time ago, but it's my particular treasure...I would also like to particularly remember the Japanese Grand Prix at Motegi, which started in 2000 and has always had such an enthusiastic crowd. Thank you again.As for what I will do from now on... I don't really know yet. I haven't made up my mind yet what I will do after retiring from competition, but I hope to stay involved in trials in some way. I'm confident that everything will go well in my new life."Shinya Wakabayashi | Honda Racing Corporation President"I would like to thank Takahisa [Fujinami] for the 26 years of his life he devoted to Trial World Championship competition. He has competed in the premier class of trial competition not only always representing Honda, but Japan, and his illustrious career deserves nothing but the greatest of praise. I believe it must have been a Herculean challenge for him to focus on his inner self, and to continue to compete at the pinnacle of motorsport for such a long time. He has suffered on many occasions from injuries which prevented him from performing at his peak. However, his unequalled love for trials has enabled him to overcome difficulties and keep on competing over the years. I would like to thank the team, who have supported him throughout his racing career, our sponsors, and all of his fans everywhere."Takahisa Fujinami ProfileBirthdate: January 13, 1980 (41 years old)Birthplace: Mie, JapanFujinami's Trial RecordsTrials: 354 (Trials record)Wins: 34 (5th)Total championship points: 4,722 (Trials record)Youngest winner: 17 years and 237 days oldOldest winner: 41 years and 151 days old (as of September 15, 2021) Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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ClinTex (CTi) Launches CTi-OEM Blockchain Clinical Trial App

LONDON, Aug 3, 2021 - (ACN Newswire via SEAPRWire.com) - The ClinTex (CTi) tokenized platform (clintex.io) will be the first of its kind to utilize blockchain-based clinical data analytics to address the main causes of clinical trial inefficiency, helping to drive down the cost of new medicines and expediting their delivery to patients.ClinTex (CTi) launches 'Operational Excellence Module' (CTi-OEM) - a blockchain clinical trial application to tackle clinical trial inefficiencies and high costs. (ClinTex)The initial spark of an idea that would eventually become ClinTex started in 2014, at the DIA Forum in Vienna. By 2018, Clintex was formally working on the Clinical Trials Intelligence (CTi) platform. CTi's purpose is to deliver data analysis at scale, to drive collaboration and insights across clinical trials.With large pharma companies like Merck and Novartis already testing blockchain as a technology of the future to support their clinical trial strategy for patient information and to manage clinical trial medication, this paves the way for ClinTex CTi to partner with the industry to deliver more innovative and impactful uses of blockchain to increase clinical trial efficiency.The CTi-OEM AppLeveraging 50+ years of medicine development experience, ClinTex has moved at a breakneck pace to launch its first blockchain clinical trial app of the CTi Platform, the Operational Excellence Module (CTi-OEM). CTi-OEM provides intuitive operational oversight of clinical trials for clinical project managers, clinical data managers and remote staff; allowing in-stream decision-making on what actions are required to ensure a successful investigation into the safety and efficacy of new medicines.Using the CTi-OEM console, researchers can deep dive into clinical trial data and take proactive action to make clinical trials run more efficiently. These operational issues include things like clinical protocol deviations and adverse events relating to patient safety in the clinical trial. The company has prioritized the development of the CTi-OEM blockchain clinical trial app to target some of the major causes of inefficiency in clinical trials, enabling its first app to derive maximum tangible benefits for the pharma and clinical trials industry. CTi-OEM achieves this through a comprehensive portfolio of tools, which is accessible through the CTi-OEM console.Compliance Requirements & Patient SafetyOne of the major obstacles to a successful clinical trial is adherence to the clinical trial protocol. Analytics within the CTi-OEM application allows the detection and analysis of these deviations and allows the clinical trial team to take speedy action. These tools provide powerful insights into the major causes of non-compliance in clinical trials providing analytics to help clinical trial teams identify and resolve them to speed up progress. Protecting patient safety during a clinical trial is the most important aspect in the development of any new medicine. Adverse events are safety issues that occur during the testing of a new medicine. CTi-OEM provides valuable insight into patient safety throughout a clinical trial. For example, adverse event rate per site allows the clinical trial team to identify those sites that have a high rate of safety events which may point to procedural problems or may also uncover safety risks that need further investigation.These are just a few examples of CTi-OEM's toolkit. For more information on CTi-OEM, there is a series of demonstration videos that give an overview of the platform, and how it can help alleviate pain points in clinical trials. Any clinical trial professionals interested in learning more or becoming early adopters can email ClinTex at industry@clintex.io or visit http://clinicaltrialsintelligence.org.CTi-OEM is just the beginning for ClinTex offerings. Eventually, the platform will consist of 7 different blockchain clinical trial applications that derive intelligent analytics from all types of clinical trial data, and it is these analytics that can be used to drive efficiency in clinical trials. The ClinTex roadmap is on track to have live client onboarding and revenue generation by the end of 2022. ClinTex SocialsTwitter : https://twitter.com/ClinTexCTiTelegram : https://t.me/ClinTexCTiMedium : https://medium.com/clintexctiYouTube : https://youtu.be/iK3zkhsDzzAWebsite : https://clintex.io/Media Contact Details Contact Email: press@clintex.io About ClinTexClinTex CTi (Clinical Trials Intelligence) is a solution provider to the pharmaceutical industry, a new type of software platform aimed at transforming the medicine development industry through the application of predictive analytics, machine learning, and the novel use of blockchain technology and smart contracts in clinical trials. Our mission is to bring down the cost of medicine and improve the speed to market of new medicines for the people who need them, through vastly reducing development costs for the global pharmaceutical industry. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

ADELAIDE, AUS, Jun 4, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.Results from the survey found:- 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities- less than half of respondents were aware of Australia's 43.5% rebate on clinical research spend- only 52% knew that studies could achieve regulatory approval in under 5 weeks in AustraliaThe survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering(TM) platform to discuss the benefits of conducting trials in Australia.Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia. "Sponsors are well aware of the quality of research from Australia however it seems from the survey that some key benefits including data acceptance, the rebate, and accelerated regulatory approval are still not widely known," said Yvonne Lungershausen. "The clinical trial environment in Australia supports rapid regulatory approval and includes one of the most attractive rebates on clinical costs as part of the Australian Government's clinical trial attraction incentive program."Avance Clinical has recently won the BDO Excellence in Business Award 2021 for rapid managed growth and attracting and nurturing experienced staff in a competitive global environment. The mid-sized CRO has a reputation for going beyond the industry standard time and support for Sponsors and providing staff the training and resources needed to deliver excellence in clinical research management.About Avance ClinicalAvance Clinical, Australia's CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class investigators and sites able to access specific patient groups. Visit http://www.avancecro.com for more information.Recent Awards:Excellence in Business Award 2021Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020Other benefits of working with Avance Clinical include:1. The Government R&D grant offers up to 43.5% rebate on clinical trial spend2. COVID-19 clinical continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class investigators and sites7. Access to sites/Phase I facilities with established healthy subject databases and specific patient populations8. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research9. Seasonal studies: Northern hemisphere sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons10. Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.Media Contact: media@avancecro.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Avance Clinical Releases Industry Survey Results at BIO Korea 2021

ADELAIDE, AUS, May 27, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development. "As Australia's CRO for biotechs, we are seeing an increasing number of South Korean biotechs selecting Australia to accelerate their Phase I and II trials," she said. "The high-quality of our data for FDA and other regulatory authority approvals is a key factor in the decision-making process."The clinical trial environment in Australia supports rapid startup and a rebate of more than 40% on clinical costs as part of the Australian Government's clinical trial attraction incentive program.In addition, Avance Clinical is accredited by the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-TrialsAbout Avance ClinicalAvance Clinical, Australia's CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class investigators and sites able to access specific patient groups. Visit http://www.avancecro.com for more information.Recent Awards:Excellence in Business Award 2021Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020Other benefits of working with Avance Clinical include:1. The Government R&D grant offers up to 43.5% rebate on clinical trial spend2. COVID-19 clinical continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class investigators and sites7. Access to sites/Phase I facilities with established healthy subject databases and specific patient populations8. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research9. Seasonal studies: Northern hemisphere sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsMedia Contact: media@avancecro.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Agilex Biolabs Partners with Endpoints News on Deconvoluting Inflammation and Immunology for Clinical Trials

ADELAIDE, AUS, May 21, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Endpoints News to share the latest on deconvoluting inflammation and immunology for clinical trials, in a webinar hosted by Endpoints News Editor Arsalan Arif.Agilex Biolabs' Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:"Inflammation is a complex biological process involving a host of resident and recruited immune cells which are mobilized to infiltrate tissues in response to invading pathogens. These immune cells boast elevated numbers and heightened activation as they churn out inflammatory mediators, which act in unison to coordinate and modulate the immune response. Choosing the right bioanalytical platform for your immunology clinical trial is critical to data collection. But navigating the intricate inflammation process can be difficult."In this webinar Dr Sales will examine what these platforms look like in use, and how should you go about selecting the right one. It will also identify the most common bioanalytical platforms used during clinical trials to measure levels of inflammatory mediators in biological fluids.Using SARS-COV-2 samples, the webinar will cover a custom 10 analyte inflammatory panel and identify how the levels observed for these mediators in Covid patients compare with an uninfected patient's matrix.It will also discuss how these platforms measure specific immunological markers in clinical trial subjects by flow cytometry.Register Here May 25, 2:00 pm - 3:00 pm EDThttps://webinars.endpts.com/deconvoluting-inflammation-and-immunology-for-clinical-trials/Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/15minAbout Agilex Biolabs -- https://www.agilexbiolabs.com/Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia. Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP rodent toxicology facility in Australia.Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at https://www.agilexbiolabs.com/new-labs-videoAgilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including: - Immunophenotyping- Receptor occupancy- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling- PBMC assays and cellular mechanism of action assays Agilex Biolabs Media Contact:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

ADELAIDE, AUS, May 7, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.Avance Clinical CEO Yvonne Lungershausen said OGTR accreditation is important for our international clients. "Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector," she said. Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-TrialsAbout Avance ClinicalAustralia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. Telehealth pivot during COVID-19 pandemic - speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsMedia Contact: media@avancecro.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.Liz Doolin, Bionomics' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning. We look forward to continuing this partnership into the future."Bionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company. Bionomics said in their announcement:"BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD).The 7-day dosing PK study in ten healthy volunteers (females and males) demonstrated that at a dose of 900 mg given twice daily, the tablet formulation of BNC210 had steady-state 12-hourly exposure levels ranging from 33-57 mg.h/L which exceed the 12-hourly blood exposure of ~25 mg.h/L predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.Dr. Errol De Souza, Executive Chairman of Bionomics said, "We are extremely pleased with the results of the 7-day PK study which demonstrate that we reach steady-state levels on the second day following the start of twice daily dosing and that we not only meet but exceed the blood exposure predicted from the pharmacometric analysis as necessary for future trials. "With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021."Dr Kurt J. Sales Agilex Biolabs' Director Immunoassay said: "Anxiety and stress-related disorders have a major impact on the health and wellbeing of hundreds of thousands of Australians with more than 1 in 4 people reported to be impacted by these disorders. The effects of stress and anxiety not only impact a person's psychological well-being but also their physical well-being and productivity which in turn has a tremendous impact on the economy."Novel treatments such as BNC210 are essential weapons in the fight against anxiety and stress-related disorders. Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders."Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR. The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.Clients can also access a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity. Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.Book a confidential briefing with our scientists before you start your next clinical trial: https://calendly.com/agilexbiolabs/15minAbout Agilex Biolabs -- https://www.agilexbiolabs.com/Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough here: https://youtu.be/WNdPGkdr9FAAgilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including: - Immunophenotyping- Receptor occupancy- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling- PBMC assays and cellular mechanism of action assays (eg: ADCC)Agilex Biolabs media contact:Kate NewtonMedia@AgilexBiolabs.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

ADELAIDE, AU, Apr 22, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.Title: Decentralized Trials - No Going BackLink: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/ Time: 23 April, 2021 - 3.05 pm (Australia/Adelaide ACST).Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent."DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen. "The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk."Yvonne Lungershausen said there are considerable benefits to DCT's including:- Reduce the scheduling and travel burden on patients - providing care from the comfort of the patient's home.- Connecting patients to trials on a global scale - patients that were otherwise inaccessible under more traditional trial protocols are now available.And she said challenges include:- Missed human-to-human contact and continuity of patient care- Investigational product distribution to more remote destinations- Oversight of compliance and study procedures in the patient's homeThe presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.- Wearable devices are demonstrating enormous potential whether worn as a wrist strap or an adhesive patch on the body. AI-embedded capabilities allow these devices to measure a patient's heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data real-time.- Video calling and electronic reminders, can improve patient compliance in trials - prompting participants to take their medication at the right time or to record in their electronic diary development.- Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require the use of a lancet and finger prick whereas others do not, making clinical trials even more convenient.Take the Quiz - Test your Knowledge about Australian Clinical Trials here:https://www.surveymonkey.com/r/Australian-Clinical-TrialsAbout Avance ClinicalAustralia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Learn more at http://www.avancecro.com.Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. Telehealth pivot during COVID-19 pandemic - speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsMedia Contact: media@avancecro.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer’s Disease

TOKYO, Apr 20, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer's Research and Therapy. The manuscript describes results from Study 201, a Phase 2b proof- of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (Abeta) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm. The results of Study 201 were presented at the Alzheimer's Association International Conference and Clinical Trials on Alzheimer's Disease in 2018.The lecanemab Clarity AD Phase 3 clinical trial completed enrollment last month with 1,795 symptomatic patients with early Alzheimer's disease (AD). Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early AD. Additionally, the Phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in individuals with preclinical AD, defined as patients that are clinically asymptomatic, but have intermediate or elevated brain Aβ levels."Amyloid beta aggregates are thought to be more toxic than monomers, and we hypothesized that reducing these could represent an effective treatment approach in early stages of Alzheimer's disease," said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas. "These results from lecanemab's Phase 2b clinical trial are encouraging and the scientific community is looking forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway.""These supportive findings from the lecanemab Phase 2b study and the initiation of two Phase 3 studies are exciting for the field and provide the opportunity to further explore the key role of the amyloid beta pathway in the pathophysiology of Alzheimer's disease," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Eisai's precision pipeline approach envisions an Alzheimer's disease treatment paradigm based on a person's pathophysiological biomarker profile along the disease continuum. We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families."For more information, visit https://www.eisai.com/news/2021/pdf/enews202128pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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TOT BIOPHARM Announces A Number of Key Anti-Tumor Drugs Have Entered the Pivotal Clinical Stage in 2020

HONG KONG, Mar 24, 2021 - (ACN Newswire via SEAPRWire.com) - TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its audited annual results for the year ended 31 December 2020.Milestones of 2020 Annual Results TOT BIOPHARM's core products including mAb drug TAB008 and ADC drug TAA013 have achieved key milestones. The Company actively promoted the development of and collaboration relating to innovative drugs and have established a R&D and commercialization platform integrating mAb and ADC drugs. The Company will rapidly expand its CDMO/CMO business to create new momentum for the future development of the Company.Key milestones of pipeline products: -- TAB008 (anti-VEGF mAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted, and was accepted by NMPA in September 2020 (Note: Pre-approval registration inspection was completed in January 2021). It is expected to be approved for marketing in 2021. -- TAA013 (anti-HER2 ADC): It is the first T-DM1 ADC product entering Phase III clinical trial in China. The first participant was enrolled in July 2020. Clinical recruitment is progressing smoothly.-- TAB014 (anti-VEGF mAb): Phase III clinical trial application (IND) was submitted to FDA. Upon receiving FDA's approval, it would be exempted from the Phase II clinical trial and would directly carry out Phase III clinical trial (Note: (IND authorized by FDA in January 2021, and would directly carry out Phase III clinical trial).-- TOZ309 (temozolomide capsule): Pre-approval registration inspection was completed, and it is expected to be approved for marketing in the first half of 2021.Key milestones of commercial production plans-- In 2020, the construction of the ADC drug substance commercial production facility was completed, and the production of multiple batches of ADC drugs for clinical purposes was accomplished.-- In 2020, the GMP compliance inspection of the production workshop for chemical drugs was completed, laying a foundation for the commercial production of chemical drugs.Dr. Liu, Jun, Chief Executive officer, Chief Scientific Officer, and Executive Director of TOT BIOPHARM, said, "TOT BIOPHARM has achieved multiple targets during the year, and manifested more prominent competitive and it has gradually formed a trend of coordinated development for R&D and commercial production of innovative drugs. In 2020, our R&D achievements are encouraging! The core product TAB008, TOT BIOPHARM's Independently developed bevacizumab biosimilar, has been submitted new drug application under the new version of the Administrative Measures for Drug Registration, and has been accepted by NMPA. Moreover, ADC drug TAA013 has successfully entered Phase III clinical trial, with a leading position in China in terms of our R&D progress. In the meantime, TOT BIOPHARM has established a R&D and commercialization platform integrating monoclonal antibodies (mAb) and antibody drug conjugates (ADC). In short, medium and long-term development, we will continue to enhance its production capacity planning and expand its CDMO/CMO business, so as to meet international and domestic clinical and commercial needs, and create new momentum for the future development of the Company. 2021 will be a fruitful year for TOT BIOPHARM, our core products TAB008 and chemical drug TOZ309, are expected to be approved for marketing, thereby benefiting a large number of cancer patients. We will continue to commit on our corporate vision of improving the quality of life of cancer patients worldwide with innovative technologies through the unremitting efforts."Unique Business Models-- Our three integrated technology platforms and comprehensive industry chainWith three self-developed technology platforms and a complete international quality management system and registration team, TOT BIOPHARM has a comprehensive industry chain, covering from drug research and development, clinical research to commercial production, which lays a foundation for accelerating the progress of R&D, international market plan and CDMO business.-- Abundant Product PipelineAt present, we have 13 drug candidates, including biological drugs, TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and antibody drug conjugates (ADC), TAA013 (anti-HER2 ADC), which are indicated for various cancers with high incidence, such as non-small-cell lung cancer, breast cancer, gastric cancer, esophageal cancer and cervical cancer.-- Commercial Production Layout with Competitive EdgeTOT BIOPHARM adheres to the business philosophy of the integration of innovative R&D and commercial production. The Company has a 16,000L capacity for mAb production and ADC drug substance production facility. In September 2020, the construction of drug substance production facility was completed for the commercial production of ADCs; the production workshop for chemical drugs has completed the GMP compliance inspection, which laid a foundation for the commercial production of chemical drugs.The operations of the Company's various R&D pipelines proceeded hand-in-hand in 2020 and achieved smooth progress with the following major milestones.Soon-to-be-commercialized Drugs-- TAB008 (anti-VEGF mAb) (Non-squamous non-small-cell lung cancer (nsNSCLC)): The new drug application was submitted under the new version of the Administrative Measures for Drug Registration, and was accepted in September 2020. It is expected to be marketed in 2021.-- TOZ309 (temozolomide capsules (200mg,100mg)): The temozolomide generic drug, a chemical drug, completed the pre-approval registration inspection, and it is expected to be marketed in the first half of 2021.-- TOM312 (megestrol acetate): We have completed the commercial-scale formulation process validation through continuous technological optimization, and have successfully submitted the ANDA application in Taiwan.Clinical Trial Progress and Achievement-- TAA013 (anti-HER2 ADC) (HER2-positive breast cancer): Phase III clinical trials were initiated in June 2020 with the first patient enrolled in July, and it is currently at the stage of clinical recruitment. It is planned to be launch in the market in 2023.-- TAB014 (anti-VEGF mAb) (wet age-related macular degeneration (wAMD)): We have completed the pivotal Phase III clinical trials and CDE consultation, and directly carried out the Phase III clinical trials exempting from the domestic Phase II clinical trials. At the same time, we submitted the investigational new drug (IND) in respect of the Phase III clinical trial application of TAB014, based on the data from the Phase I clinical trial of TAB014 conducted in China and relevant clinical literature data, this IND application is a direct application for authorization to conduct Phase III clinical trial (being exempted from Phase II clinical trial).-- TIC318 (carboplatin) (epithelial-derived ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, testicular tumors, malignant lymphoma, cervical cancer, bladder cancer and NSCLC): We have completed commercial-scale formulation process validation in the high active drug injection workshop.Commercial Production and CDMO/CMO Strategic CollaborationTOT BIOPHARM increased resource investment, actively promoted CDMO/CMO business, and developed diversified strategic collaboration with domestic and foreign pharmaceutical companies to provide customers with high-standard and high-quality CDMO/CMO services.-- The Company's commercial production technology demonstrates a sharp competitive edge in cost effect. Its self-developed perfusion-batch combined process flows, PB-Hybrid Technology, can realize commercial production direct scale-up from 25L to 2,000L in the cell culture process, thereby streamlining process flows, reducing production risks while shortening production cycles, lowering production costs, and greatly improving production capacity and cost advantages.-- For the year of 2020, the Company has reached commercial collaboration with several innovative pharmaceutical companies to provide CDMO/CMO services for new drug R&D partners, including the CDMO collaboration with Kintor Pharmaceutical Limited (9939.HK) to continue providing clinical supplies manufacture and technical support for its core product Proxalutamide in China and the United States. At the same time, we provide Kintor clinical supplies manufacture for the novel coronavirus disease (COVID-19) overseas (including the United States, Brazil, etc.), pursues diversified collaboration opportunities while increasing the Company's cash flows.Future DevelopmentEmbrace openness and win-win collaboration to promote domestic and internationalcommercial collaboration for drug candidates: At present, TOT BIOPHARM has multiple product pipelines such as biological drugs, ADC drugs and chemical drugs, which are stepping into the commercial stage with huge market potential. TOT BIOPHARM has been adhering to the principle of openness, collaboration and win-win, and discusses future commercial development strategies with various domestic and foreign partners. Relying on R&D, clinical trials and a one-stop full industry chain platform of application, manufacturing and commercialization, TOT BIOPHARM actively seeks the strategic collaboration domestically and internationally. We will obtain milestone funds through the transfer of domestic and foreign sales rights. Through diversified collaboration models, we share resources, accelerate the progress of product R&D and marketing, and rapidly occupy domestic and foreign market shares to enhance market competitiveness. Leveraging our unique advantages in R&D and production, we strengthen CDMO/CMO business collaboration to provide pharmaceutical companies with production capacity and technological requirements which they are lack of, and help customers shorten production time and reduce production costs in a cost-effective manner.Financial Highlights-- Revenue amounted to RMB22,491,000, representing a 50% year-on-year decrease, mainly attributable to the impact of the national volume-based procurement policy on the sales derived from the distribution of brand-name drug S-1, and the alignment of our CDMO business with our customers' planned schedules.-- Research and development expenses amounted to RMB235,196,000, representing a 23% year-on-year increase, mainly attributable to the commencement of Phase III clinical trial for the TAA013 project of the Company in 2020 after the completion of Phase I clinical trial that resulted in an increase in demand for active pharmaceutical ingredients (APIs), excipients and consumables by related contract research (CROs) and those for the preparation of clinical drugs.-- Selling expenses amounted to RMB25,953,000, representing a 18% year-on-year decrease, mainly attributable to the overall economic slowdown as a result of the outbreak of COVID-19 in 2020 which led to the suspension or postponement of various marketing events.-- General and administrative expenses amounted to RMB46,855,000, representing a 51% year-on-year decrease, mainly attributable to the inclusion of listing expenses in the expenses for the same period in 2019.-- In summary, net loss for the year of 2020 amounted to RMB288,498,000, representing a 4% year-on-year decrease.About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumour drugs and therapies, striving to build a leading brand of oncology treatments worthy of the trust of patients and their families, and medical professionals. The Company has in place three major integrated technology platforms. They are:Therapeutic Monoclonal Antibody and ADC Technology Platform: it integrates research and development (R&D) and production capacities for antibody-based drugs and ADC, with the designed production capacity of the commercialization base of biological drugs reaching 16,000L to accommodate high-quality commercialization of drug candidates; Gene Engineering Based Therapeutics Technology Platform: it integrates anti-tumour immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumour-targeted oncolytic virus products;Innovative Drug Delivery Technology Platform: a comprehensive platform for the process development and commercial production of high intensity and frequency of drug injections. It adopts a production design with aseptic lyophilization and aseptic filling to satisfy the GMP production requirement of OEB 4/5 active level lyophilized powder and water needle.Using these platforms, the Company has studied and developed various anti-tumour drug series and genres, and has formed a high quality and comprehensive drug product chain. On top of developing innovative proprietary drugs, the Company also draws on its own industry value chain to build a complete industry chain platform that supports operations from R&D and production and clinical development to marketing. By adopting an open platform business model, it is able to cooperate with biomedical enterprises and third parties at different stages along its industry value chain.For enquiries:Strategic Financial Relations (China) LimitedAnita Cheung / Winnie Lau / Christina Chong / Tin TimTel: (852) 2864 4827 / 2864 4876/ 2864 4899 / 2114 4907Email: sprg-tot@sprg.com.hk Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Fujitsu Embarks on Joint Research with National Cancer Center Japan to Create New Services for Drug Development and Clinical Trials

TOKYO, Mar 18, 2021 - (JCN Newswire via SEAPRWire.com) - Fujitsu today announced it has concluded a comprehensive collaborative research agreement with National Cancer Center Japan. The joint research will center on exploring ways that real-world data(1), including medical information from electronic records, can be leveraged to contribute to the development of new drugs, clinical trials, and preventive medicine in pharmaceutical companies.Through its joint research with the National Cancer Center, Fujitsu aims to create new value through a wide range of information and analysis services by creating an anonymized personal health record scheme(2) (PHR), which includes case study information and health information on patients visiting the National Cancer Center Hospital East. Fujitsu additionally seeks to create a platform for providing pharmaceutical companies with data that can be used for drug development and preventive medicine. Fujitsu will establish a new model to process medical information from electronic medical records into highly secure statistical data to improve the efficiency of clinical trials and supports active participation in international joint clinical trials by promoting the adaptation of clinical trial data in Japan to global standards.(3)With an eye to contributing to the wellbeing of people in society, Fujitsu will work to improve the development speed and quality of pharmaceuticals and other products that promote the health of consumers. In turn, Fujitsu will play a role in resolving issues such as the time required for clinical trials and costs, create a variety of services that contribute to areas such as preventive medicine and individualized cancer medicine, and implement these services by the end of fiscal 2021.BackgroundIn recent years, real-world data has been attracting increased attention in the healthcare field, and it is beginning to be used in a wide range of fields globally--from drug approval applications to the development of medical devices and preventive medicine. A variety of different data types are being used to these ends, ranging from patient electronic medical record information and medical examination information, to daily measurement data such as weight and body composition monitors(4), as well as vital information such as temperature and blood pressure that can be obtained from smart devices.Despite the potential for such data, however, challenges remain around extracting useful information from unstructured sources like doctors' notes, etc., and it has become necessary to develop new platforms and data extraction technologies to effectively and securely streamline the use of valuable medical data. To this end, Fujitsu has concluded a comprehensive agreement with the National Cancer Center with the ultimate goal of contributing to the speedy development of pharmaceuticals and clinical trials by pharmaceutical companies that promote the health of consumers and will start joint research in this field.About the Joint Research1. OverviewIn collaboration with the National Cancer Center, Fujitsu is implementing three projects to utilize real-world data at the National Cancer Center Hospital East.Verification of utilization of real-world data (real-world data share) - In addition to medical information from the electronic medical record systems, which has been difficult to use until now, information on case studies and information on the health of local patients (PHR) is processed into a format that is easy for pharmaceutical companies to handle and provided as secure, high-quality data. The effectiveness of using real-world data in developing new AI technologies to support diagnoses and treatment will also be verified.Establishment and validation of new clinical trial service models (DX for Clinical Trial Operations) - Natural language analysis technology will be applied to the analysis of medical information in the electronic medical record system in order to establish a new clinical trial service model that can automatically identify appropriate clinical trial patients with overwhelming speed and accuracy. This process is presently performed manually with reference to medical information in the electronic medical record system (clinical trial patient recruitment). Through this study, the effectiveness of the system in significantly reducing the cost and duration of clinical trials, including improving the efficiency of in-hospital operations will be verified.- Fujitsu will promote efforts to adapt clinical trial data in Japan to global standards and support active participation in international clinical trials.Establishment of a platform for safe and secure use of medical data (common platform) - In order to carry out these two verifications, Fujitsu will develop a platform that can safely and securely utilize medical data by converting medical information recorded as text data in the electronic medical record system into a format that can be utilized as data. This platform utilizes technology developed by Fujitsu Laboratories, Ltd., as well as data extraction technology that is being newly developed.2. Role of Fujitsu, National Cancer CenterFujitsu- Development of technologies and platforms needed to utilize real-world data- Verifying streamlining of clinical trial operations with patient recruiting function- Coordination with national policies for the utilization of PHRs (5)National Cancer Center- Provision of medical data at National Cancer Center Hospital East- Provision of know-how on clinical practice, clinical research, and clinical trials- Verification of the contents of joint research3. Period of Joint ResearchMarch 16, 2021 ~ March 31, 20234. LocationNational Cancer Center Hospital East and Exploratory Oncology Research & Clinical Trial CenterFuture PlansIn the future, Fujitsu will not only collaborate with pharmaceutical companies, but also consider working with various companies that provide wellbeing-related products and services to consumers in Japan and throughout the world. Based on the results of this joint research, by the end of fiscal 2021 Fujitsu will develop platforms and services that enable the safe and secure use of real-world data and provide wellbeing to consumers. Through the provision of these platforms and services to pharmaceutical companies, Fujitsu aims to contribute to the streamlining of drug development and clinical trials.(1) real-world data：Data generated by daily medical care and personal health management.(2) PHR：A system in which individuals collect and manage their own medical information and other health-related information. Refers to information that can be subject to disclosure control at the discretion of the individual.(3) international joint clinical trials：A clinical trial conducted simultaneously in multiple countries or regions.(4) weight and body composition monitors：a measuring instrument that measures weight and body fat percentage and visceral fat levels etc.(5) National policies:For example, policies led by Data Health Reform Promotion Headquarters of the Ministry of Health, Labour and Welfare such as "Health, Medical, and Nursing Care Information Utilization Study Group".About FujitsuFujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 130,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.9 trillion yen (US$35 billion) for the fiscal year ended March 31, 2020. For more information, please see www.fujitsu.com. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Avance Clinical and Medidata Celebrate Strategic Partnership and Inhouse Expert Accreditation Milestones

ADELAIDE, AU, Feb 26, 2021 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical continues to celebrate their strategic partnership with Medidata, and the accreditation of seven Medidata inhouse experts.The two organizations have been working together to deliver world-class clinical research services to Avance Clinical's biotech customers via the Medidata Rave Clinical Cloud™.Avance Clinical, Chief Strategy Officer, Ben Edwards said "We look forward to many more years working with Medidata as we continue to grow the business and support the development needs of our clients."Mr Edwin Ng, Senior Vice President, General Manager for Medidata APAC, said, "We are pleased to be supporting Avance Clinical's exceptional growth in Australia. Avance Clinical accreditation signifies the importance of Medidata's portfolio of products in ensuring the success of our partners' programs, and our continued commitment to helping our partners streamline and enhance the clinical research process."Avance Clinical, Director Business Development Operations, Sandrien Louwaars said, "The Medidata Rave Clinical Cloud™ is a quality- and efficiency-focused unified platform that helps our biotech clients, and ensures data integrity, speed, and compliance across multisite and global studies."Our seven Avance Clinical accredited Medidata experts lead our efforts, and it makes a real difference for our clients having them inhouse rather than as external consultants."Contact us about your next study. https://www.avancecro.com/eclinical-solutions/About Avance Clinical - www.avancecro.com Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups.Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. eClinical solutions - speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsAbout Medidata - www.medidata.comMedidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,600+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systemes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata, The Operating System for Life Sciences™.Medidata is a registered trademark of Medidata Solutions, Inc., a wholly-owned subsidiary of Dassault Systemes.About Dassault Systemes - www.3ds.comDassault Systemes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systemes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systemes, a French "societe europeenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.Media Contact: Chris Thompsonmedia@avancecro.comKoh Shu Meishumei.koh@omnicomprgroup Copyright 2021 ACN Newswire. All rights reserved. www.acnnewswire.com

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O2 and NEC jointly conduct Open RAN trial

TOKYO, Feb 2, 2021 - (JCN Newswire) - O2 (Telefonica UK) and NEC Corporation (TSE: 6701) have announced a successful Open RAN trial on O2's network with NEC and its ecosystem of partners that includes virtualized RAN software from Altiostar and hardware from GigaTera Communications and Supermicro among others.NEC helped to define a customized Open RAN architecture, optimized and adapted to the requirements of the O2 mobile network. Given its role as the system integrator for this trial, NEC coordinated the overall design of the system, which delivered a solid end-to-end solution and was conducted in collaboration with the aforementioned industry leaders. NEC's role included end-to-end testing and interoperability verification by leveraging its recently established Center of Excellence in the UK, which is where the trial with O2 was conducted, running via O2's core network. The trial builds on O2's progress in developing Open RAN technologies over the past 12 months. In January 2020, new windowO2 announced a range of Open RAN projects to help its customers better utilize its network, and its parent company, Telefonica, is playing an active role in Open RAN networks. Telefonica announced earlier last year its intention to launch 4G and 5G Open RAN trials in Germany, Spain and Brazil, as well as building on early success in the UK. Derek McManus, COO of O2 said, "The partnership between NEC and O2 promises to accelerate the provision and growth of Open RAN solutions in the UK. O2 will continue to transform our network through collaboration and the optimization of new technologies such as Open RAN."Mayuko Tatewaki, General Manager, Service Provider Solutions Division, NEC Corporation, said, "We are extremely excited to be driving this journey on the home ground of our Open RAN Center of Excellence in the UK. Through close collaboration with O2, we are honored to contribute to the diversification and innovation of network transformation."About NEC CorporationNEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.About Telefonica UKO2 is the principal commercial brand of Telefonica UK Limited, part of the global telecommunications group Telefonica S.A, headquartered in Spain and operating in Europe, and North, Central and South America. No.1 Network: O2 is the UK's largest network with more than 34 million connections, providing 2G, 3G, 4G and 5G services while operating a nationwide O2 Wifi service. For three consecutive years O2 has won Best Network Coverage provider at the publicly voted USwitch Awards (2018, 2019, 2020). It won Best Network Performance at the Mobile News Awards 2019 and was named Most Reliable Network by GWS in 2020. The company is the network of choice for mobile virtual network operators giffgaff, Sky Mobile and Lycamobile and manages a 50:50 joint venture with Tesco for Tesco Mobile. Copyright 2021 JCN Newswire. All rights reserved. www.jcnnewswire.com

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China Biotech Services LY007 Cell Injection Obtained Clinical Trial Approval Letter

HONG KONG, Jan 28, 2021 - (ACN Newswire) - China Biotech Services Holdings Limited ("CH BIOTECH SER" or "Company", stock code: 8037.HK) non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd. ( "Shanghai Longyao") received an approval letter from the National Medical Products Administration for a clinical trial of the Company's LY007 Cellular Injection on January 21, 2021, which is registered as a Class I new drug. LY007 Cellular Injection is mainly used for the treatment of non-Hodgkin lymphoma. It is currently the first and only CD20-targeted CAR-T product whose application for a registered clinical trial has been approved in China.LY007 Cellular Injection is a chimeric antigen receptor T-cell (CAR-T) injection and is mainly used in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and metastatic follicular lymphoma. LY007 Cellular Injection has beenwas developed independently by Shanghai Longyao and incorporates its patented OX40 co-stimulatory signal design. Experiments have proved that the design enhances the efficacy of the Product without compromising safety. According to the clinical trial application of LY007 Cellular Injection, Shanghai Longyao will commence Phase I clinical trial and study of LY007 Cellular Injection based on the submitted proposal.The National Medical Products Administration's approval of Shanghai Longyao's clinical trial application for LY007 Cellular Injection demonstrates Shanghai Longyao's capabilities in the research and development of immunocellular drugs.According to a research report issued by China Merchants Bank on CH BIOTECH SER on November 20, 2020, the analyst recommended to watch for the results of the LY007 Cellular Injection clinical trial which could enhance the company's market value. The report also pointed out that the company's current market capitalization is slightly less than US$200 million while market capitalization of CAR-T comparable companies listed on the main board of the Hong Kong Stock Exchange is between US$600 million and US$1.4 billion. The current market value of CAR-T comparable Chinese companies listed on NASDAQ is approximately US$3.5 billion. Copyright 2021 ACN Newswire. All rights reserved. www.acnnewswire.com

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SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SN1011 in China

HONG KONG, Jan 18, 2021 - (ACN Newswire) - SinoMab BioScience Limited ("SinoMab" or the "Company", 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 the first healthy subject was successfully dosed in the Phase I clinical trial of SN1011, an innovative third-generation covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor drug candidate, today in Shuguan Hospital in Shanghai, China. The subject is currently in a normal condition.Medical staff from Shuguan Hospital in Shanghai conducted the Phase I clinical trial of SN1011.SN1011 is the third generation, covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of systemic lupus erythematosus, rheumatoid arthritis, pemphigus, multiple sclerosis and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of selectivity and affinity. The Phase I clinical trial was conducted in Shuguan Hospital in Shanghai, aiming to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in treatment for autoimmune diseases. SinoMab received the approval of SN1011's Investigational New Drug application ("IND") from the National Medical Products Administration of China on 27 August 2020, taking less than 5 months to progress into the current dosing stage, which utterly proves the Company's efficient implementation of new drug R&D programs.Dr. Weian YUAN, Principal Investigator from Shuguan Hospital in Shanghai for this Phase I Study, said, "So far, there are a number of BTK inhibitors that have been approved, but there is no third-generation BTK inhibitor that is yet approved. Since the third generation BTK inhibitor has much lower effective dose and a better safety profile, it makes SN1011 a promising product to bring patients a much better treatment."Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said, "SN1011 successfully completed its first dose, representing another key R&D asset entering the stage of clinical trial following our flagship product, SM03. This is a prominent milestone along SinoMab's progress in the R&D of various products for autoimmune diseases. Last year we launched the multiple ascending dose cohorts for SN1011 in Australia. SN1011, which shows great safety in clinical trials, possesses advantages of working just in a small dose and continuously benefitting patients, outperforming other BTK inhibitors in the market. We are absolutely confident in the enormous prospects of SN1011's clinical development. We will accelerate the program in the future, hoping to provide safe, effective and affordable drugs for patients suffering from autoimmune diseases around the world."About SN1011Bruton tyrosine kinase is a key kinase in the BCR signaling pathway in the B cell. Owing to the fact that loss of BTK exerts great impact on B cell development, targeting BTK becomes an attractive therapeutic means for autoimmune disease. SN1011 is a third generation BTK inhibitor which is covalent reversible in binding nature. It has unique chemical structure which renders it high binding affinity and selectivity towards BTK and excellent bioavailability in animal model. SN1011 has better efficacy and safety than other BTK inhibitors in pre-clinical studies. These data support the long-term usage for the treatment of autoimmune diseases in human.About SinoMab BioScience Limited SinoMab BioScience Limited ("SinoMab" or the "Company", 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, non-Hodgkin's lymphoma, asthma, and other diseases with major unmet clinical needs. Copyright 2021 ACN Newswire. All rights reserved. www.acnnewswire.com

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Smart letterboxes to be trialled at two Clementi Housing Board blocks

SINGAPORE - Residents of Block 202 Clementi Avenue 6 will soon be able to receive notification on their mobile phones when mail has arrived, negating the need to periodically check their letterbox. For the next year in fact, they will not need to check the letterbox at all, as mail will instead be collected from a central vending machine-style unit at the foot of the block. They will be the first in Singapore to try out a smart letterbox system that SingPost envisions may one day replace traditional units. Called PostPal, each machine will store mail for an entire housing block, with items auto-sorted into storage slots. Instead of using a key to unlock their designated letterbox, residents will scan a QR code generated by the SingPost app to retrieve their items from the machine. Using the app, residents can also be notified of mail delivery, check the number of items pending collection and authorise others to collect mail on their behalf. PostPal features significant improvements that will reduce misdeliveries and alleviate the postman's burden, SingPost said on Thursday (Dec 3) in announcing a year-long public trial. PostPal has an autosort function, which means the postmen will only need to load all the mail into the machine without sorting them out individually. The trial will start with two Housing Board blocks in Clementi; residents of Block 202 Clementi Avenue 6 will begin using the system on Dec 18, while those in Block 205 will follow in the weeks ahead. PostPal is a newer iteration of the smart letterbox prototype unveiled by SingPost last year. It was developed in collaboration with PBA Group, a robotics and automation firm headquartered in Singapore. The storage modules in PostPal units can be customised to the mail profile of each individual block, SingPost said. A block that sees consistently high e-commerce volumes, for example, can have smaller modules in its PostPal replaced with larger ones that can accommodate bigger postal packages, it said. This configuration can also be done during the year-end online sale peak season, it added. The postal service provider has said that traditional letterbox units are not equipped to meet the growing demands of e-commerce, especially as smaller items are often sent by mail instead of courier services, which can be more expensive. Mr Vincent Phang, SingPost's Singapore head and chief executive of postal services, told The Straits Times in an interview in September that the accelerated growth of e-commerce prompted by the Covid-19 pandemic has made the need to revamp the postal infrastructure more urgent. It is an opportune time to test the smart letterbox system as demand for contactless deliveries and Singaporeans' comfort with scanning QR codes have increased, Mr Phang noted then. PHOTO: SINGAPORE POST He said in a statement on Thursday that the PostPal trial has the potential to transform the letterbox infrastructure in Housing Board blocks from a "simple, letter-oriented lock-and-key structure to a cutting-edge digital system with capabilities beyond mail delivery". It will also significantly alleviate SingPost's labour constraints, he added. The PostPal public trial will be progressively rolled out to more precincts, subject to the performance of the units in Clementi as well as approval from the authorities, SingPost said. Data and feedback gathered during the trial will be used to finetune the smart letterbox system, as well as to inform the next phase of SingPost's transformation plans, it added. To familiarise residents with using PostPal, SingPost staff will be stationed at the void deck of Block 202 Clementi Avenue 6 from noon to 8pm on weekdays and 9am to 9pm on weekends starting on Dec 11. Residents can call 6845-6222 or email postpal@singpost.com with PostPal-related queries and feedback. More on this topic   Related Story SingPost to trial smart letterbox system as e-commerce surges   Related Story SingPost to launch new uniforms for postal staff

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Avance Clinical Wins MasterControl 2020 Innovation Excellence Award

ADELAIDE, AU, Oct 30, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical today accepted the MasterControl 2020 Innovation Excellence Award in a virtual ceremony.L-R: Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer, Yvonne Lungershausen, Avance Clinical's CEO, and Lisa Eglinton, Director Compliance and Training.Avance Clinical made the announcement today at AusBiotech 2020 (28 - 30 October, 2020).https://www.ausbiotechnc.org/Avance Clinical CEO Yvonne Lungershausen said the company was very pleased to be awarded such recognition by MasterControl, a leader in the clinical digital management technology. The MasterControl Clinical Excellence solution streamlines eTMF management and helps clients achieve real-time visibility into critical clinical processes across operational teams - all on one centralized platform. https://www.mastercontrol.com/clinical/"The award acknowledges our leadership as Australia's biotech CRO and it provides further confidence to our clients that we are serious about delivering quality clinical research services by being nimble and adaptive, and by utilising state-of-the-art systems that are compliant with industry standards, such as MasterControl eQMS," said Yvonne Lungershausen."Avance Clinical invests significantly in the industry's leading clinical technologies making it one of the most advanced CROs globally for digital clinical research management and eClinical solutions." On presenting the Innovation Excellence Award, MasterControl said the award recognises "the power of innovation and celebrates companies who feel the same way we do, who are not afraid to shed the status quo to find their own path and who push boundaries and spearhead important changes within their industries. Companies driven by innovation who truly live and breathe it."Avance Clinical Director Quality Assurance, Priyanka Chamoli, said:"Receiving the award from MasterControl is a testament of our commitment to invest in our Quality Management System and to continually improve and strengthen it. This Award recognises and provides visibility to our efforts to push boundaries and adopt this significant change not just for the Quality Assurance department but across-the-board in the organisation.""MasterControl eQMS enables accurate, streamlined processes for Document Control and Training. Avance Clinical, which is on a significant growth trajectory, requires robust procedures as part of our QMS. MasterControl has allowed our staff to create/review and access our controlled documents in real-time and the automated link between different modules enables timely delivery of training."Avance Clinical Director Compliance and Training, Lisa Eglinton said:"MasterControl Training Module provides a robust, user-friendly method for the delivery of role-specific training programs to all staff. The system provides a real-time indication of training status to Trainees and their Line Managers which ensures training compliance across the company."Avance Clinical is the leading Australian owned CRO that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.Considering Australia? Contact us about your next study. https://www.avancecro.com/eclinical-solutions/See Image here http://bit.ly/AvanceClinicalMasterControl(From left to right) Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer, Yvonne Lungershausen, Avance Clinical's CEO, and Lisa Eglinton, Director Compliance and Training.About Avance Clinical www.avancecro.comAustralia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. eClinical solutions - speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsMedia Contact: media@avancecro.comChris Thompson Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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Agilex Biolabs Client Shasqi Announces Click Chemistry Breakthrough with First-Ever Human Application in Launch of Clinical Program

ADELAIDE, AU, Oct 30, 2020 - (ACN Newswire) - Agilex Biolabs, Australia's most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, congratulates client company Shasqi on the announcement of the first-ever application of click chemistry in humans, with the launch of the Company's lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development.San Francisco-based Shasqi said in the announcement: First Patients Dosed in Phase 1 Clinical Study of SQ3370 for Advanced Solid Tumor Malignancies Shasqi is First Y-Combinator Biotech Company to Reach First-in-Human Clinical StudiesShasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPACtm) Platform, announced today the first-ever application of click chemistry in humans, with the launch of the Company's lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development. The first two patients have been dosed in Shasqi's Phase 1 clinical study of SQ3370 for the treatment of advanced solid tumors. SQ3370 is a novel investigational product that activates a non-toxic protodrug into a powerful chemotherapy agent, doxorubicin, precisely at a pre-injected tumor. SQ3370 is designed to allow substantially higher drug doses to be given to the patient, increasing tumor destruction while minimizing toxicity in the rest of the body. "Shasqi is founded on the belief that one day we will be able to beat cancer without poisoning our bodies. We are excited to reach this milestone with our CAPAC Platform and the launch of Shasqi's first clinical program," said Jose M. Mejia Oneto, M.D., Ph.D., Founder and CEO of Shasqi. The CAPAC Platform is a new therapeutic modality based on click chemistry, which leverages biocompatible chemical reactions, to activate protodrugs at a selected tumor that has been pre-injected with a biopolymer. The CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity, rendering it applicable to a broad array of tumor types. Additionally, the CAPAC Platform is highly modular and can be applied to a wide variety of cancer therapeutics in addition to doxorubicin."Doxorubicin has been proven effective for dozens of cancers, but severe side effects limit its use. Guiding it directly to the tumor while avoiding damage to the rest of the body may allow us to use doxorubicin and potentially many other drugs in a completely new and effective way for patients," commented Wayne Saville, M.D., Chief Medical Officer of Shasqi. "Shasqi has taken a novel concept through a rigorous preclinical regulatory path all the way to treating patients in near-record time." "Shasqi was Y Combinator's first therapeutic biotechnology investment and now the first of our life sciences companies to reach clinical development," said Jared Friedman, Partner, Y Combinator. "We are extremely impressed by the team's rapid advancement and capital-efficient execution. SQ3370 and CAPAC are not just a standard new small molecule, but rather a broad and powerful new platform leveraging state of the art science and materials to transform the treatment of cancer." SQ3370-001 (NCT04106492) is a multicenter, first-in-human, dose-escalation, Phase 1 clinical trial evaluating the safety and tolerability, pharmacokinetics, immune effects, and preliminary anti-tumor efficacy of SQ3370 in patients with locally advanced or metastatic solid tumor malignancies ineligible for standard-of-care therapy. The study is being conducted in the United States and Australia at multiple cancer centers, including MD Anderson Cancer Center and Stanford University. The study is expected to be completed in 2021. More information about the trial is available at: https://clinicaltrials.gov/ct2/show/NCT04106492. See the announcement here. https://tinyurl.com/y2splohjAgilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.Agilex Biolabs' world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-videoAgilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including: - Immunophenotyping- Receptor occupancy- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling- PBMC assays and cellular mechanism of action assays (eg: ADCC)Agilex Biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs companies from US, Europe and APAC.Please Book a Briefing with us before you start your next clinical trial.About Agilex Biolabs https://www.agilexbiolabs.com/Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 20 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.Agilex Biolabs Media Contact:Media@AgilexBiolabs.com Kate NewtonShasqi media contact:David Rosen, Argot Partners media@shasqi.com +1 (212) 600-1902 Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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Biotechs get scalable early to late phase clinical offering from Avance Clinical and Cromos Pharma – announced at Bio-Europe 2020

BIO-Europe, Munich, Oct 28, 2020 - (ACN Newswire) - Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions."We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies," said Yvonne Lungershausen, CEO of Avance Clinical. "Our eClinical and early phase expertise is well augmented by Cromos Pharma's track record in late stage trials and rapid enrollment capabilities," she continued."We have been collaborating with Avance Clinical and referring clients to each other for years," remarked Vlad Bogin, CEO of Cromos Pharma."But it was a true Eureka moment when we realized that combining Australia's 43.5% tax rebate with Central/Eastern Europe's unbeatable recruitment rates is a paradigm shift in how clinical trials should be conducted," he concluded.Cromos Pharma can access hundreds of millions of patients via more than 2,500 sites in Central/Eastern Europe.About Cromos Pharma, www.cromospharma.comCromos Pharma provides tailored and effective clinical trial solutions to support the development of drugs that transform healthcare. An international CRO with over 15 years' experience, we offer fully integrated services performing all aspects of clinical trials in all clinical phases and in a wide range of therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has strong regional experience in Central and Eastern Europe with global coverage provided by its US bases in Portland, Oregon and Miami, Florida. Cromos Pharma's European HQ is in Dublin, Ireland. At Cromos Pharma, we know how important your product is. When the stakes are this high, you need a high-performance partner. Key benefits:- International expertise combined with in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials conducted in 70+ indications). - Extensive PI/site and patient network (40,000+ patients enrolled from nearly 2,500 trial sites).- Unparalleled patient recruitment - our team met or shortened project timelines in 95% of conducted trials.- Responsible recruitment is supported by Cromos Pharma's "No Patients-No Payments" initiative - a unique risk-sharing program. - Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).- Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2).- Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection).- Clinical Development Strategy - we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.About Avance Clinical, www.avancecro.comAustralia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations for biotechs. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Other benefits include:1. The Government R&D grant means up to 43.5% rebate on clinical trial spend2. eClinical solutions capabilities - speed and continuity3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks4. No IND required for clinical trials5. Full GMP material is not mandated for Phase I clinical trials6. Established clinical trial environment with world-class Investigators and sites7. Established healthy subject databases and specialized patient populations8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasonsMedia Contacts: Avance Clinical Chris Thompson: media@avancecro.comCromos PharmaNicola Donnelly: media@cromospharma.com Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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