-Monoclonal antibody TY014 advanced from initiation to clinical development was in a record time of 7 months, which manifests the combined efforts between Tychan and WuXi Biologics for timely intervention against future outbreaks of infectious diseases
-WuXi Biologics completed all IND-enabling CMC studies in 7 months breaking a record of 9 months it achieved for Zika mAb vs traditional 15-24 months
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 for dosing of first individual in phase 1 trial of TY014, a first-in-class monoclonal antibody candidate treatment for Yellow Fever (YF), immediately following the investigatory new drug (IND) approval from Health Sciences Authority (HSA) of Singapore to evaluate safety and tolerability on November 26.
TY014 is the first monoclonal antibody designed and engineered to treat Yellow Fever Virus-infected patients to enter the clinic. It is directed against the envelope (E) protein on the surface of the virus, and prevents viral replication by limiting viral fusion to host cells. TY014 progressed from initiation to regulatory submission in less than seven months due to substantial advances in Tychan's proprietary rapid development platform and the company's partnership with WuXi Biologics. There is currently no approved treatment for Yellow Fever (YF). Tychan aims to complete safety assessments in time to intervene if there is a YF outbreak in early 2019.
YF is a mosquito-borne hemorrhagic disease caused by the Yellow Fever Virus (YFV) that has in the past caused epidemics leading to significant human and economic losses. Nearly 15 percent of patients infected with YFV develop life-threatening illness involving haemorrhage, jaundice and shock. Of these, approximately 30 percent die of their disease. Sudden spurts in global demand from ongoing outbreaks have previously resulted in a shortage of existing vaccines, leaving millions at risk. This risk is particularly acute if YFV spreads beyond Africa and South America into Asia.
"The unprecedented speed with which TY014 advanced from project initiation to clinical testing makes it possible for us to meet the urgent need for an available intervention should a global Yellow Fever crisis erupt. It is a manifestation of Tychan's drive for a capability to quickly find treatments to new infectious disease outbreaks in endemic regions," said Teo Ming Kian, Chairman of the Board, Tychan. "Moreover, the shortening of the timeline to regulatory approval from our previous work in Zika validates our approach and inspires us to reach our ultimate goal: to do this within weeks rather than months."
"Tychan's rapid biologics development for infectious diseases is consistent with our mission to accelerate and transform how biologics are developed and manufactured globally. This first-in-class antibody against Yellow Fever Virus developed in a rapid time underscores both our world-leading technical capability and validation of this exciting approach to treat emerging infectious diseases. We are prepared to scale up production to combat any potential global outbreak," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics.
About the Trial
The first-in-human clinical trial will be conducted in Singapore in approximately 67 healthy volunteers. Volunteers in the Phase 1 trial will be split into 2 parts to test the safety and tolerability of TY014 as well as its effectiveness as an antiviral drug. The Company aims to complete safety assessments in time to test efficacy if there is a YF outbreak in early 2019.
The trial is 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 Yellow Fever Virus
Yellow Fever Virus (YFV) is a single-stranded RNA virus that is genetically related to Dengue, West Nile, Zika and Japanese encephalitis viruses. Yellow Fever (YF) is an acute viral haemorrhagic disease caused by the Yellow Fever Virus (YFV), a re-emerging arbovirus transmitted by the Aedes mosquitoes. Clinical symptoms of YF include fever, chills, headaches, jaundice, muscle aches, nausea and fatigue.
According to the Centre for Disease Control (CDC) in Atlanta, USA, YFV can currently be found in the tropical jungles of South America and Africa, causing an estimated 200,000 infections and 30,000 deaths annually. It has become a growing public health problem, threatening to spread beyond the geographic boundaries of the two continents. The outbreak of YF in Brazil earlier this year has sparked great concerns that it would potentially become an urban epidemic.
Although a safe and effective vaccine is currently available, global shortages of supplies have severely hampered efforts in the prevention and control of YFV outbreaks. To-date, no YFV therapy (biologic or small molecule) has advanced to clinical trials. It is anticipated that a monoclonal antibody therapeutic could be administered to infected cases to reduce disease severity within the patient.
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. HSA approved clinical testing of Tychan's Tyzivumab, the world's first Zika therapeutic candidate in 2018, which successfully completed phase 1 trials in September 2018, just 16 months after project initiation. Tychan aims to further its development platform and build on its partnerships to facilitate timely delivery of safe and effective therapeutics that are critical for preparedness against pandemics caused by emerging infectious agents such as YFV.
Tychan was 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 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.
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