Tychan‘s first-in-class monoclonal antibody candidate treatment for Yellow Fever (YF), called TY014, has successfully completed Phase 1A/1B safety trials in Singapore, it announced today. Tychan received regulatory approval from the Health Sciences Authority (HSA) of Singapore in November last year to conduct human trials for TY014, after a record setting timeline of 7 months from candidate to regulatory submission. Tychan has also received regulatory approval in Brazil to conduct a field study in YF affected areas.
Using a novel clinical design, the trials were initially conducted in healthy volunteers before, also being tested in volunteers vaccinated with yellow fever vaccine. 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 safety, efficacy and pharmacokinetic data will be presented at the Late-Breaker session of this year’s annual conference of the American Society of Tropical Medicine and Hygiene (ASTMH) held November 20th–November 24th at the Gaylord National Resort and Convention Center National Harbor, Maryland USA.
YF is a mosquito-borne haemorrhagic disease caused by the Yellow Fever Virus (YFV) endemic to 47 countries in Sub-Saharan Africa, Central and South America for which there are no treatment options available. According to the Centre for Disease Control (CDC) in Atlanta, USA, nearly 15% of the patients infected with YFV develop life threatening illness involving haemorrhage, jaundice, and shock, often leading to death. Despite the existence of an effective YFV vaccine, a sudden spurt in global demand from ongoing outbreaks has resulted in a shortage that leaves millions at risk, especially in Africa and South America. In Brazil alone, 723 cases with 237 deaths were reported between July 2017 and February 2018 and additional outbreaks in Ethiopia where 10 deaths were reported. Although the seasonal outbreak in the summer of 2018 in Brazil was substantially less, Yellow Fever outbreaks have continued in Africa and there remains a critical unmet medical need for a therapeutic option for this deadly disease. Moreover, those who receive vaccination, especially the vulnerable or high risk groups, remain at risk of serious and life threatening vaccine-related adverse effects with no treatment options.
“This is an exciting development towards a strategy for intervention in YF disease for which no treatment exists, and I look forward to field studies which will provide additional scientific rationale for TY014,“ said Dr Mauro Teixeira, Professor of Immunology at the Department of Biochemistry and Immunology, Universidade Federal de Minas Gerais, Brazil, and principal investigator of the field study for TY014 in Brazil.
“The successful trial paves the way for a first of its kind treatment for yellow fever. This rapid development following the similar achievement for Zika affirms the first ever innovative technology platform and boosts the confidence in Tychan’s development of rapid response capability against deadly infectious diseases. It brings us one step closer to our ultimate objective of addressing sudden infectious disease outbreaks,” said Teo Ming Kian, Chairman of the Board, Tychan.
Rapid development and manufacture of TY014 and Tyzivumab — the Zika therapeutic, were both completed in record times enabled by a joint partnership with WuXi Biologics. The completion of Phase 1 trials for both of its infectious disease pipeline products occurred within 8 months of IND approval.
“Congratulations to Tychan on reaching another great milestone with the world’s first Yellow Fever antibody candidate. We are proud to empower Tychan’s achievements through our single-source integrated biologics technology platform, expediting the timeline of biologics from DNA to clinical trials. Leveraging our strong expertise and capabilities to accelerate the development and manufacture of innovative biologics, WuXi Biologics continues to empower global partners, allowing them to provide more life-saving treatments to meet emerging health challenges,” said Chris Chen, CEO WuXi Biologics.
Tychan’s technology platform was developed by its founders, Professor Ram Sasisekharan of Massachusetts Institute of Technology (MIT) /Singapore MIT Alliance for Research and Technology (SMART) and Professor Ooi Eng Eong, Deputy Director, Emerging Infectious Diseases Programme, Duke-NUS Medical School, Singapore and Co-Director, Viral Research and Experimental Medicine [email protected] Duke-NUS (ViREMiCS) with funding support from Temasek Holdings, Singapore.
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