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Tychan Launches Phase 3 Clinical Trial of New Monoclonal Antibody TY027 for COVID-19 | Corporate Finance
Singapore-(BUSINESSWIRE)-December 10, 2020-
June 2020, Tichan A phase I clinical safety study in humans has begun to evaluate TY027, a monoclonal antibody (mAb) that specifically targets SARS-CoV-2, the virus that causes COVID-19. In October 2020, the Singapore Health Sciences Authority (HSA) approved a Phase 3 clinical trial to begin as part of the progress of antibody development. The exam will begin at Singapore’s partner hospitals, Singapore General Hospital and National University Hospital, with Changi General Hospital and Sengkang General Hospital as referral sites.
It is believed that TY027 may slow the progression of the disease, accelerate recovery, and provide temporary protection against infection with SARS-CoV-2 for the treatment of patients with COVID-19.
The results of the Phase 1 clinical trial showed no serious adverse events when injecting TY027 into healthy volunteers, and researchers evaluated doses up to 30 mg / kg. Research and Phase 1 trials supporting new drug applications in chemistry, manufacturing, control, etc. have been completed thoroughly and safely.
The Phase 3 clinical trial is the final phase of the TY027 trial and will involve 1,305 volunteer COVID-19-positive patients from partner hospitals. If the antibody proves effective in this study, it will be submitted as a new drug for review by HSA and other regulators.
Due to the low incidence of COVID-19 in Singapore, Phase 3 clinical trials of TY027 will also be conducted at overseas affiliated hospitals such as the Sheba Medical Center in Israel. With the support of Singapore’s government-wide cooperation in the development of COVID-19 antibody, Tychan is exploring collaboration with medical facilities in other countries.
Tychan has worked with the Defense Ministry, the Ministry of Health, the Economic Development Board, and other government agencies to develop TY027 as part of a government-wide collaboration. Research on the development of TY027 for COVID-19 was completed in less than 4 months. This is an improvement over Yellow Fever and Tychan’s successful mAb efforts, which took seven months from design to first injection in humans. 9 Months. Such development usually takes 12-18 months. These systematic improvements validate the significant advances in the development of Tychan’s rapid response platform. This was made possible by breakthrough thinking and innovation with a team of founders, Professor Ram Sasisekharan and Professor Ooi Eng Eng.
“As COVID-19 continues to spread around the world, we witness not only the health brought about by the COVID-19 pandemic, but also the economic and social misery, and we quickly provide potential solutions. I’ve been working for it. ” Professor Sasisekharan. “We hope that TY027 will soon become a valuable option for patients affected by this catastrophic disease.”
This accelerated timeline is made possible by the use of Tychan’s unique technology and the Rapid Response platform developed by Professors Sasisekharan and Ooi. The platform was also used to develop the company’s new mAB, TY014, which was recently announced for yellow fever. New England Journal of Medicine Similar to the development of Tyzivumab for the treatment of Zika fever.
“Singapore has successfully contained COVID-19, so the incidence of this disease is very low. Therefore, we are considering collaboration with other countries. The incidence of COVID-19 remains high. We are pleased to begin Phase 3 clinical trials in partnership with Sheba Medical Center while seeking collaboration with other healthcare facilities in some countries up to. TY027 has passed Phase 3 clinical trials and COVID-19 We hope that it will be deployed as soon as possible to mitigate the negative effects of this, “says Professor Oi.
“We are confident that the development process for TY027 is rapid and could be a rapid response platform for future infectious diseases,” added Tychan Chairman Teo Ming Kian. “Tychan’s Rapid Response platform aims to shorten the timeline for future development of TY027 and work with international partners to address the damage caused by COVID-19 and other emerging infectious diseases. We will respond to the large-scale needs for this. “
Tychan’s efforts to use proprietary technology to build rapid response capabilities to outbreaks of infectious diseases were first supported by the Temasek Foundation Ecosperity and Temasek Life Sciences Lab in the rapid setup of laboratories and production facilities. Without it, this accelerated timeline would not have been achieved. ..
Tychan, a Singapore-based clinical biotechnology company, is focused on bringing disruptive technology to those in need of life-saving treatment for emerging infectious diseases. Through collaborative work with regulators, the company is accelerating the transition from nonclinical trials to clinical trials of new pathogens. It was founded by Professor Ram Sasisekharan of the Massachusetts Institute of Technology (MIT) / Singapore MIT Research and Technology Alliance (SMART) and Professor Ooi Eng Eong of the National University of Singapore (Duke-NUS) Medical College. Biological development and biology of acute viral infections. Temasek Holdings is a founding investor in Tychan. For more information on TychanPte. Co., please visit: www.tychan.com..
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Industry Keywords: Research Medical Supplies Infectious Diseases Hospital Clinical Trials Biotechnology General Health Pharmaceuticals Health Sciences
Copyright Business Wire 2020.
PUB: 12/10/2020 11:00 PM / DISC: 12/10/2020 11:00 PM
Copyright Business Wire 2020.
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