HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.
The candidate, TY-027, has already shown full clearance of the virus in laboratory studies and demonstrated safety in preclinical studies. It has also successfully cleared a three-week drug stability test.
“TY-027 is a novel monoclonal antibody that we engineer through our proprietary technology and is tested in laboratory and preclinical studies,” Ram Sasisekharan, co-founder of Tychan, told BioWorld. “It is designed to mimic the immune system’s response to SARS-CoV-2, and bind to the spike protein of SARS-CoV-2 and potently neutralizes the virus.
“TY-027 is being explored to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2.”
Tychan joins an increasingly crowded race to find a cure, and its accelerated timeframe puts it in a good position. To date, there is no proven antibody-based treatment for COVID-19 and there is also no licensed vaccine to prevent the infection.
The phase I trial is to be conducted by the Singhealth Investigational Medicine Unit with the green light given by the Health Sciences Authority, Singapore’s regulatory agency.
Tychan will seek to establish the efficacy of the MAb candidate upon reaching the key milestones of the phase I trial. It expects to make the efficacy data available in the third quarter of this year.
The accelerated time frame for TY-027 is achievable due to the use of the company’s proprietary technology and rapid response techniques. “We are able to shorten the development timeframe because we use a unique stepwise approach to the entire development process,” said Sasisekharan. “This approach allows us to conduct all traditional components of development with logical and safe overlapping in order to allow a more rapid overall analysis.”
The development of TY-027 has taken only four months to this point, including discovery and laboratory and preclinical studies. According to the company, that process usually takes anywhere between 12 to 18 months.
The company is keeping its focus on this COVID-19 candidate in their pipeline.
“Developing treatments for rapidly emerging infectious diseases is what we do. Currently, our focus is COVID-19. We have also developed treatments for Zika and yellow fever,” said Sasisekharan.
Working fast is not a new thing for the clinical-stage biotechnology company. Tychan’s previous successful MAb efforts in yellow fever took a mere seven months from design to first-in-human infusion; efforts in Zika took nine months.
That same speed is expected to be applied to plans for future trials.
“Because of the rapid response process developed and implemented by the company, we anticipate being able to initiate phase III trials this summer,” said Sasisekharan.
Asia first region for rollout
Tychan developed TY-027 in partnership with several Singaporean government agencies, including the Ministry of Defence, Ministry of Health and the Economic Development Board.
“Rapidly developing a cure for COVID-19 is exactly the raison d’etre of Tychan,” said Teo Ming Kian, the company’s chairman. “While still a few months away from knowing if we are successful, we are hopeful because of our success in the development of MAbs against Zika and yellow fever. We will continue with the fast pace of development as we are conscious that a day saved is a day less of misery.
“Although done with great speed, the development is not fast enough for those who have lost their lives and their loved ones, and had their livelihoods disrupted and economies ravaged. What we want to do is to not only help people around the world avoid the devastating effects of COVID-19, but better prepare for the next unfortunate infectious disease outbreak through the learnings of developing therapeutics for each outbreak”, he added.
Tychan is staying quiet about its exact marketing plans. However, Sasisekharan confirmed that the biotech company is “in active discussions with numerous partners” to address different geographies, and Asia will indeed be the first region for the rollout.
Tychan’s aim is to establish a rapid response capability against infectious disease outbreaks using its technology. The company’s rapid establishment of its lab and production facilities was first supported by Temasek Foundation Ecosperity and Temasek Life Sciences Lab.
The Singaporean government’s investment firm Temasek Holdings Pvt Ltd. is the founding investor of Tychan.