China’s Biotech Firm Is Now Leading the Race to a Coronavirus Vaccine As Testing Approaches Phase 3

CanSino Biologics Inc, a Chinese biotechnology firm, has remained the lead company in the world developing a SARS-CoV-2 vaccine. Here's how they have stayed ahead of other giant pharmaceutical companies.

CanSino was established in 2009 in Tianjin, China after four scientists left their global pharmaceutical companies in Canada. They have successfully developed the Ad5-EBOV vaccine for the Ebola virus and continue to develop 16 other vaccines for 13 infectious diseases, including COVID-19.

By May, they were the first company in the world to publish their human trials, allowing other companies to review their clinical study. This became a crucial step because it allowed researchers worldwide to assess a vaccine's potential.

Wang Ruizhe, a pharmaceutical analyst at Capital Securities Corp. said that the company 'deserves credit for the speed with which they pushed the vaccine through pre-clinical studies and human testing. It tells you something about their ability to mobilize and leverage the resources that it takes to get all these done. The resources required here are substantial.'

Phase I Trials

In Phase I of their coronavirus vaccine clinical trials, 108 participants had good antibody and T-cell responses against the virus. Professor Wei Chen from the Beijing Institute of Biotechnology, said 'these results represent an important milestone. The trial demonstrates that a single dose of the new adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation.'

Although the immune response was triggered by the vaccine they developed, it doesn't guarantee protection against the virus. Dr. Chen said that the vaccine is still a long way from being widely available. At that time, there were around 100 vaccine candidates with 12 companies doing human trials.

Currently, about 36 companies developing vaccines are being tracked by the Regulatory Affairs Professionals Society with around 23 conducting clinical trials. Yu Xuefeng, the company's CEO who formerly worked as the senior executive at the Canadian company Sanofi, continues close relations with the Canadian government.

'CanSino is in the game and it's about where the other so-called leaders are,' said William Haseltine, formerly a Harvard University HIV researcher. 'Whether anybody will cross the finish line where we ever can see safety data that we would like to see is unknown.'

Promising Efforts

Phase II clinical trials have taken place in Wuhan, where the virus first appeared. They have begun testing with low and middle doses, equating to about 50 billion and 599 billion virus particles. They are also working with Precision NanoSystems, a company in Vancouver, for the development of an mRNA lipid nanoparticle vaccine.

CanSino will soon enter Phase III of its vaccine testing. Relations with Canada's National Research Council will allow Canada to produce the vaccine if it becomes approved for emergency pandemic use.

Wang shared, 'The viral vector CanSino is using is a relatively safe approach compared to other techniques but it's hard to make a call on efficacy for now. There's no shortage of histories where promising efforts made it to the last stage of testing only to see things fall apart.'