Wuxi Biologics will manufacture supplies of Tychan’s developmental yellow fever biologic for clinical trials.

The drug in question – known as TY014 – is a first-in-class monoclonal antibody. It targets the envelope (E) protein on the surface of the yellow fever virus and prevents replication by limiting fusion to host cells.

Earlier this month Tychan announced it had successfully completed Phase IA/IB safety studies. The firm also said it received regulatory approval to test the drug in a field study in yellow fever affected areas in Brazil.

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The announcement was welcomed by WuXi Biologics, which worked with Tychan on the development of TY014.

CEO Chris Chen told this publication the CDMO was involved in all aspects of CMC development for the product “from cell line to process and analytical, tox materials and GMP supplies.”

He also confirmed that Wuxi Bio will be manufacturing TY014 for future trials adding the firm would also “potentially” be involved in commercial production if the product goes on to be approved by regulators.

Wuxi Bio used its proprietary cell line development platform WuXia on the TY014 project. According to the CDMO’s website, the technology uses the same vector system for early development and the production of stable cell lines in a bid to shorten timelines.

Manufacture was conducted at Wuxi’s development and facility in Shanghai using single-use bioprocessing technologies.

Zika partnership

WuXi Bio and Singapore-based Tychen are also collaborating on the development of a monoclonal antibody called tyzivumab. The drug, a candidate treatment for Zika disease virus infection, completed Phase I trials last year.

Wuxi Bio has been involved in all aspects of the Zika project and is the process of setting up manufacturing capacity in Singapore with the support of the country’s Economic Development Board.

In May last year, the CDMO committed S$80 million – roughly $60 million – to the project. It said the facility would house single-use bioreactors with total capacity of 4,500 L and an early-stage bioprocess development laboratory.

Wuxi Bio’s role in both projects was acknowledged by Tychan chairman Teo Ming Kian who said, “Our successful trials pave the way for a potential first-in-class treatment for Yellow Fever.

“This rapid development following the similar achievement for Zika affirms the exciting collaboration between Tychan and WuXi Biologics to enable a new paradigm to expedite biologics development initially to address emerging infectious disease outbreaks and eventually to potentially expand to other therapeutics.”