Singapore-based clinical-stage biotechnology company, Tychan announces results for Phase 1 Trial for TY014, a novel monoclonal antibody candidate treatment for yellow fever.
Results of Phase 1 trial testing the safety and efficacy of TY014, a novel monoclonal antibody candidate treatment for yellow fever were published in the New England Journal of Medicine in late July 2020. The results of the trial found substantial reduction of monoclonal antibody (mAb) development time through the use of Tychan’s proprietary rapid-response platform.
The platform developed by co-founders Prof. Ram Sasisekharan and Prof. Ooi Eng Eong, and offers a roadmap for research of therapeutics for other infectious diseases, including COVID-19.
The published data showed the safety and tolerance of TY014 even at the highest tested doses, as well as was able to provide complete treatment of the yellow fever virus of all participants within 48 hours of infusion. These results pave the way for a Phase 2 trial to be conducted in areas in which yellow fever is endemic.
“Much thought has been given to the design of the trial. The strategy is to accelerate the study of TY014 for yellow fever as the disease has a mortality rate of 20 – 50%. There is no treatment specifically indicated for yellow fever, and the currently available vaccine is contraindicated for the most vulnerable populations, including infants, pregnant women, the elderly and the immunocompromised,” said Prof. Ooi Eng Eong, Co-founder of Tychan and Deputy Director, Emerging Infectious Diseases Programme, Duke-National University of Singapore Medical School.
Phase 1 of the trial was split into two parts, namely, Phase 1A and 1B. In Phase 1A, it evaluated safety, tolerability, and pharmacokinetics of TY014 in healthy volunteers in five randomized cohorts in a double-blinded design. One of the cohorts received a placebo. Through this phase, TY014 demonstrated safety and efficacy with 100 percent of subjects testing negative for yellow fever within 48 hours after infusion.
For Phase 1B, safety, tolerability as well as efficacy of the monoclonal antibody was further tested adopting a time-lagged, parallel group, randomized, placebo-controlled, double-blinded design. Volunteers were given a weakened version of live yellow fever vaccine before treatment with TY014. At 48 hours post treatment, none of the volunteers in the phase 1B study who received the starting 2 mg/kg TY014 dose had detectable yellow fever virus in the bloodstream.
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 (ViREMiCS).
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.
“Speeding access to effective therapeutics is an imperative and a high priority as infectious disease outbreaks will happen with increasing frequency and with greater adverse impact on lives and livelihoods, societies and economies. The COVID-19 pandemic is a case in point,” said Ram Sasisekharan, PhD, a founder of Tychan as well as professor in Biological Engineering and Health Sciences & Technology at MIT.