Tianjin CanSino Biologics (HK: 6185) announced plans for a Phase II trial of its COVID-19 vaccine only three weeks after starting its Phase I test. In a filing with the Hong Kong Stock Exchange, CanSino says it expects to start the trial soon. The Phase II trial will enroll 500 healthy volunteers, who will receive one of two vaccine dose levels or a placebo. At 14 days, subjects will be examined for adverse reactions. At 28 days, participants' serum levels of anti-SARS-CoV-2 neutralizing antibodies and antibodies against the coronavirus’s spike protein will be measured. Subjects will be followed for up to six months.

The CanSino vaccine is an adeno-associated virus serotype 5 (AAV5) vector encoding the SARS-CoV-2 spike protein. It was developed in partnership with China's Academy of Military Medical Sciences.

To justify the Phase II test, CanSino used preliminary safety data from the Phase I trial, which was conducted in Wuhan among healthy volunteers,. It has not released that data, but the company probably based its safety assessment on examinations for adverse effects conducted seven days after administration. The 108 subjects in the Phase I trial were given one of three levels of the vaccine.

In the Phase II trial, also planned for Wuhan, 250 subjects will be administered the middle dose of the current Phase I trial, and 125 will receive the low dose of the Phase I trial. 125 enrollees will be given a placebo. The high dose of the Phase I trial was dropped from the second round protocols, though the company did not explain its reasoning. CanSino has already started signing up volunteers via a QR code on the internet.

Although Moderna and its partner, the US National Institutes of Health, were the first to start a Phase I test of a COVID-19 vaccine, CanSino now seems to be ahead, though the process isn't a horse race. Both companies are more or less at the same point in development. Moderna's mRNA candidate injects a stabilized form of the spike protein the coronavirus uses to infect host cells.

Founded in 2009, CanSino has developed a pipeline of fifteen candidates for twelve diseases, including meningitis, pneumonia, tuberculosis, Ebola, pertussis, diphtheria, tetanus, shingles and others. Six of the candidates have started clinical trials or at the clinical trial application stage. There are also six pre-clinical vaccine candidates under development, including one combination vaccine candidate.

The company has built an R&D operation and advanced cGMP manufacturing infrastructure with capacity up to 80 million doses.
The company completed an $161 million IPO on the Hong Kong exchange in March 2019 and is reported to be considering a second listing on the Shanghai STAR exchange.

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Disclosure: none.