WuXi Biologics ("WuXi Bio"), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner Tychan on successful completion of the Phase 1A/1B safety and efficacy trials in Singapore for TY014, a first-in-class monoclonal antibody candidate treatment for Yellow Fever (YF).
WuXi Biologics completed all of TY014’s CMC studies for Investigational New Drug (IND) application in record 7 months through its single-source integrated biologics technology platform. The seamless partnership between Tychan and WuXi Biologics accelerates the timely delivery of safe and effective therapeutics that are critical for preparedness against pandemics caused by emerging infectious agents.
"Our successful trials pave the way for a potential first-in-class treatment for Yellow Fever. This rapid development following the similar achievement for Zika affirms the exciting collaboration between Tychan and WuXi Biologics to enable a new paradigm to expedite biologics development initially to address emerging infectious disease outbreaks and eventually to potentially expand to other therapeutics," said Teo Ming Kian, Chairman of the Board, Tychan.
"Congratulations to Tychan on reaching another great milestone with the world’s first Yellow Fever antibody candidate. We are proud to empower Tychan to expedite the timeline of high-quality biologics from DNA to clinical trials. Leveraging our strong expertise and capabilities to accelerate the development and manufacturing of innovative biologics, WuXi Biologics will continue empowering global partners and allowing them to provide more life-saving treatments to meet emerging health challenges," said Dr. Chris Chen, CEO of WuXi Biologics.
About TY014
TY014 is the first monoclonal antibody designed and engineered to treat Yellow Fever Virus infected patients to enter the clinic. TY014 is directed against the envelope (E) protein on the surface of the virus, and prevents viral replication by limiting viral fusion to host cells.
About the Trial
The first in human clinical trial was conducted in Singapore in approximately 27 healthy volunteers. Volunteers in the Phase 1 trial were split into 2 parts and randomised into one of five dose cohorts, each receiving a single dose of TY014 or placebo. The primary endpoints of the study were safety and tolerability and secondary endpoints include pharmacokinetics and immunogenicity. In the second part the volunteers received live attenuated yellow fever vaccine before treatment with TY014 or placebo. The primary endpoints of this arm was safety and tolerability as well as complete aviremia in treatment cohorts.
The results indicated that TY014 was not only safe and well tolerated at the highest doses tested, but also suppressed vaccine virus and related adverse effects. The trial was 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 Centre@SingHealth Duke-NUS (ViREMiCS).
About Tychan
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 Holdings is the founding investor of Tychan Pte. Ltd.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong, S.A.R., China-listed company, is a leading global open-access biologics technology platform 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 strong value proposition to our global clients. As of June 30, 2019, there were a total of 224 integrated projects, including 106 projects in pre-clinical development stage, 102 projects in early-phase (phase I and II) clinical development, 15 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, Singapore and the U.S. exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.
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