SINGAPORE, Dec. 6, 2018 /PRNewswire/ Tychan, a clinical-stagebiotechnology company based in Singapore,announced today that its first-in-class candidate drug for the treatment of Yellow Fever receivedinvestigatory new drug (IND)regulatoryapproval from Health Sciences Authority (HSA) of Singapore to evaluate safety and tolerability.Immediately following the IND approval on November 26, the first individuals were dosed with TY014, a monoclonal antibody, on December 6 in a phase I trial of healthy volunteers. There is currently no approved treatment for Yellow Fever (YF). Tychan aims to complete safety assessmentsin time tointervene if there is aYFoutbreakin early 2019.
TY014 progressed from initiationto regulatory submission in less thansevenmonths due to substantial advances in Tychan's proprietary rapid development platform and the Company's partnership with WuXi Biologics. TY014isthe firstmonoclonal antibody designed and engineered to treatYellow Fever Virus-infected patientsto enter the clinic.It is directed againstthe envelope (E)protein on the surface of the virus,and prevents viral replication bylimiting viral fusion to host cells.
"Theunprecedentedspeed withwhichTY014advancedfromproject initiationtoclinical testing makes it possible for us to meet theurgent need foran availableinterventionshould aglobal YellowFevercrisiserupt. Itis a manifestation ofTychan'sdrive for a capability toquickly findtreatmentsto new infectious disease outbreaksin endemic regions,"said Teo Ming Kian, Chairman of the Board, Tychan."Moreover, theshorteningof thetimelineto regulatory approval from ourprevious work in Zikavalidates ourapproachand inspires us to reach ourultimate goal:to do this within weeks rather than months."
YFis a mosquito-borne hemorrhagic disease caused by the Yellow Fever Virus (YFV) that has in the past caused epidemicsleading to significant human and economic losses.Nearly 15 percent of patients infected with YFV develop life-threatening illness involvinghaemorrhage, 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 beyondAfrica and South America into Asia.
"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 capabilityand validation of this exciting approach to treat emerging infectious diseases. We are prepared to scale up production to combat any potential global outbreak,"saidChris Chen, CEO,WuXi Biologics.
About the Trial
The first-in-human clinical trialwill beconducted in Singapore in approximately67healthy volunteers. Volunteers in the Phase 1 trial will besplit into two groups to test thesafety and tolerabilityof TY014 as well as its effectiveness as an antiviral drug.The Companyaims to complete safety assessmentsin time totest efficacy if there is aYFoutbreakin early 2019.
The trial is being administered by SingHealth Investigational Medicine Unit, led by Associate Professor Jenny Low, Senior Consultant, Department of Infectious Diseases,Singapore General Hospitaland Co-Director, Viral Research and Experimental Medicine Centre@SingHealth Duke-NUS (ViREMiCS).
AboutYellow Fever Virus
Yellow Fever Virus (YFV)is a single-stranded RNA virus that is geneticallyrelated to Dengue, West Nile,Zikaand 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 Aedesmosquitoes. 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. YFVcan currently be foundinthe tropical jungles ofSouth 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 outbreakof YFin Brazil in 2018 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 beadministered to infected cases to reduce disease severity within the patient.
Tychan, a Singapore clinical-stagebiotechnology company,isfocused on bringing life-saving treatments for emerging infectionsto those in needthrough disruptive technologies.Inacoordinated effortwith regulatoryauthorities,we areaccelerating the translation from non-clinical studies to clinical trials for emergingpathogens. 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.Tychanaimstofurther its development platform andbuild on its partnerships to facilitate timely delivery of safe and effective therapeuticsthat are critical for preparedness againstpandemics caused by emerging infectious agentssuch as YFV.
Tychan was founded byProfessor 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.For more information, please visit:www.tychan.com
About WuXi Biologics
WuXi Biologics, 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. For more information on WuXi Biologics, please visitwww.wuxibiologics.com.
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