Tianjin CanSino Biologics (HK: 6185; SHA: 688185) reported its AD5-nCOV vaccine met interim primary safety and efficacy endpoints without any serious adverse events.  CanSino said it expects to see unblinded interim results from the trial later this week. The Phase III clinical trial of Ad5-nCoV enrolled 40,000 volunteers of all ages in 78 clinical trial sites located in five countries. CanSino's candidate is delivered by an adeno-associated virus serotype 5 (AAV5) vector and was China's first COVID-19 vaccine to begin clinical trials.

Unlike inactivated vaccines, CanSino's vaccine is effective with a single dose and can bring dual protection - humoral and cellular immunity - at the same time. The vaccine can be stored and transported at temperatures between 2 and 8 degrees Centigrade. Its production does not require biosafety level three laboratories.

Based on the readout, CanSino will continue the Phase III clinical trial. After an earlier trial showed the vaccine was safe, China approved use of the vaccine among military personnel.

CanSino said it has completed case accrual for the interim analysis of the Phase III clinical trial of Ad5-nCoV, and the data from these cases was submitted to the Independent Data Monitoring Committee (IDMC) for analysis and recommendation. Because CanSino did not know which patients received the virus, it won't know whether the vaccine was effective until the IDMC returns the unblinded data.

The Ad5-nCoV vaccines is a recombinant adenovirus vector vaccine jointly developed by CanSino Biologics and researchers from the Institute of Military Medicine under the Academy of Military Sciences led by Chen Wei. The two entities collaborated earlier on a vaccine for Ebola.

In August CanSino raised $748 million in an IPO on the Shanghai STAR exchange and climbed 88% in its first trading session. That followed a $160 million IPO in Hong Kong. CanSino one year earlier. 

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Disclosure: ChinaBio has a business relationship with CanSino.