HONG KONG – In just seven months, Singapore-based biotech company Tychan Pte Ltd. has moved its monoclonal antibody, TY-014, from initiation and into clinical development.

Tychan's treatment is intended for yellow fever and would be the first cure for that ailment. The company managed the quick progression due to substantial advances in Tychan's rapid development platform and its partnership with Wuxi Biologics.

"The unprecedented speed with which TY-014 advanced from project initiation to clinical testing makes it possible for us to meet the urgent need for an available intervention should a global yellow fever crisis erupt. It is a manifestation of Tychan's drive for a capability to quickly find treatments to new infectious disease outbreaks in endemic regions," said Teo Ming Kian, chairman at Tychan.

"Moreover, the shortening of the timeline to regulatory approval from our previous work in Zika validates our approach and inspires us to reach our ultimate goal: to do this within weeks rather than months."

Ram Sasisekharan, co-founder of Tychan, told BioWorld that the firm's development approach for TY-014 is similar to that used for tyzivumab, Tychan's anti-Zika drug.

"We used computational design to rapidly develop MAb candidates with high and broad neutralization activity against yellow fever [YF] virus. We focused on a key viral surface protein known as virus envelope protein that appears to be accessible, mutationally constrained and conserved across YF strains," Sasisekharan explained. "Indeed, MAbs targeting these regions are known to be potent, as widely observed and reported in dengue virus infection."

Yellow fever is spread by infected mosquitoes. Thus, the treatment would find a ripe market in tropical territories.

"Apart from Latin America and Africa where the outbreaks have been active, there are several nations in Asia that are prone to a potential yellow fever outbreak," Sasisekharan said. "This is because of the probability of occurrence of the Aedes aegypti mosquito under current environmental and land cover conditions in many nations in Asia, including China, India, Indonesia and Singapore, among other countries."

Tychan's home base is included in the list.

"Following SARS, Singapore has been concerned about pandemics and how best Singapore can respond to such outbreaks. This provided the right environment to explore important innovations needed for rapid response for emerging infectious agents," said Sasisekharan.

TY-014 is the first monoclonal antibody designed and engineered for yellow fever to enter the clinic. It is directed against the envelope (E) protein on the surface of the virus, and is designed to prevent viral replication by limiting viral fusion to host cells.

The first in-human trial will involve 67 healthy volunteers in Singapore to assess safety, tolerability and effectiveness. Tychan aims to complete safety assessments by early 2019.

Research against the clock

This is not the first time Tychan has worked against the clock to develop a cure.

In February, the clinical-stage firm dosed its first patient with a first-in-class Zika antibody, tyzivumab, in a phase Ia trial in Singapore. The IND package for tyzivumab was developed in a speedy timeframe of just nine months.

"The current paradigm of taking years to bring a drug from discovery to the clinic does not allow us to effectively deal with outbreaks of emerging diseases," said Teo.

"To make a difference to outbreak interventions, research discovery must be translated into medicines within such timelines."

"The discovery and development of tyzivumab is not just a story about scientific advance, but also of how collaborative efforts between key parties, many of whom are based in Singapore, can produce results that fundamentally change the way the world thinks about drug development," said Daniel Hastings, the CEO and director of SMART, Singapore MIT Alliance for Research and Technology. SMART's "contribution to this first-in-class human testing of this important antibody via licensing relevant intellectual property is consistent with MIT and SMART's mission of research for impact."

Chris Chen, the CEO of Wuxi Biologics, said that firm is prepared to scale up production in case of a global outbreak.

Sasisekharan revealed that the current plan is to partner with a large pharma and determine a suitable distribution model.

The company is also excited about the treatment's potential for other indications.

"As you can imagine, there are many pathogens that cause outbreaks in Asia such as Nipah or hand, foot and mouth disease in children," Ooi Eng Eong, a co-founder of Tychan and a deputy director of Duke-National University of Singapore's Emerging Infectious Diseases Programme, told BioWorld. "We are actively exploring such targets."