SHANGHAI, Oct. 29, 2018 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company that offers end-to-end solutions for biologics discovery, development and manufacturing, today congratulates its partner Tychan on successful completion of Phase-1 safety trials in Singapore for Tyzivumab, first-in-class monoclonal antibody (mAb) therapeutic for Zika, Tyzivumab, in Singapore.
Tychan, a Singapore clinical-stage biotechnology company, is focused on bringing life-saving treatments for emerging infections to those in need through disruptive technologies. In partnership with WuXi Biologics, the completion of Tyzivumab from discovery to human safety studies was in a record time of 17 months, which enables Tychan focusing on making potential therapeutics for emerging infectious agents.
Research shows Tyzivumab to be safe and well tolerated up to the highest dose tested. This paves the way for this antibody to be tested in Zika patients in a Phase 1b study for which Tychan has received regulatory approval from the Health Sciences Authority of Singapore. Recruitment of patients is ongoing for this study.
"Demonstration of the safety of Tyzivumab is an important milestone that puts Tychan firmly on a path towards a true rapid response capability for emerging infectious diseases that is so critically needed to overcome the threats of increasing epidemics that have often caused great misery to human lives and severe economic impact," said Teo Ming Kian, Chairman of the Board, Tychan.
"WuXi Biologics is the proud partner to enable IND filing of this exciting program in 9 months, which showcases our world-class capabilities and speed. We are committed to expediting development and manufacturing of much needed biologics for emerging infectious agents," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics.
Tyzivumab is the first-in-class monoclonal antibody designed and engineered to treat Zika infected patients to enter the clinic. Tyzivumab is directed against a specific quaternary epitope of the envelope (E) protein on the surface of the virus, limiting viral fusion to host cells and preventing viral replication.
About the Trial
The first in human Phase 1a clinical trial was conducted in Singapore in approximately 24 healthy volunteers. Volunteers in the Phase 1a trial were randomised into one of six groups each receiving a single dose of the anti-Zika monoclonal antibody. The primary endpoints of the study were safety and tolerability, and secondary endpoints include pharmacokinetics and immunogenicity. The Phase 1b trial will be conducted in approximately 28 patients with confirmed Zika infection who will be sequentially included in 4 groups each receiving a single dose of the anti-Zika monoclonal antibody. Both trials are administered by SingHealth Investigational Medicine Unit, led by Associate Professor Jenny Low, Senior Consultant, Department of Infectious Diseases, Singapore General Hospital and Co-Director, Viral Research and Experimental Medicine [email protected] Duke-NUS (ViREMiCS). The Singapore Clinical Research Institute as the Academic Research Organisation partner provides oversight, data management and analytical support.
Tychan, a Singapore clinical-stage biotechnology company, is focused on bringing life-saving treatments for emerging infections to those in need through disruptive technologies. In a coordinated effort with regulatory authorities, we are accelerating the translation from non-clinical studies to clinical trials for emerging pathogens. Founded by Professor Ram Sasisekharan of Massachusetts Institute of Technology (MIT) /Singapore MIT Alliance for Research and Technology (SMART) and Professor Ooi Eng Eong of Duke- National University of Singapore (Duke-NUS), their expertise spans the fields of biologics development and biology of acute viral infections. Temasek is the founding investor of Tychan Pte. Ltd. For more information on Tychan Pte Ltd, please visit: www.tychan.com.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of June 30, 2018, there were a total of 187 integrated projects, including 98 projects in pre-clinical development stage, 78 projects in early-phase (phase I and II) clinical development, 10 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.
SOURCE WuXi Biologics