China’s CanSino Biologics recently disclosed that the company was advancing its SARS-CoV-2 vaccine to a Phase II clinical trial making this vaccine candidate lead contender in the global race for an approved vaccine product. This decision is “based on the preliminary safety data of the Phase I clinical trial” (note the data hasn’t been shared). Working in an alliance with the government-backed Academy of Military Medical Sciences’ Institute of Biotechnology, the private-public partnership sought to progress the adenovirus type-5 vector-based recombinant SARS-CoV-2 vaccine (Ad5-nCoV) “soon.” According to disclosures with the U.S. government clinical trial registry, the study has in fact commenced in Phase II making Ad5-nCoV the world’s leading COVID-19 vaccine candidate. But Moderna, another U.S.-backed contender in Phase I with Phase II to commence by 2nd half of 2020, just received an U.S. federal government infusion of $483 million. Healthy competition can lead to a vaccine to stop SARS-CoV-2!

TrialSite News suspects there is sort of a competition building between the United States and China for the ultimate COVID-19 vaccine. Although undoubtedly lots of capital, talent and experience are in the mix here, the timing of this recent disclosure and the $483 million U.S. federal financing of Moderna evidence a race—healthy competition can be a good thing spurring the best and brightest scientists and drug development professionals to innovate, execute and hopefully produce results. The Chinese vaccine has been named as a top contender by the World Health Organization and hence the situation merits a “TSN” summary breakdown.

What is Ad5-nCoV?

This is CanSino Biologics Inc. COVID-19 vaccine: a Recombinant Novel Coronavirus Disease Vaccine (Adenovirus Type 5 Vector). Ad5-nCoV is a genetic engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein, which intends to be used to prevent the disease caused by the novel coronavirus infection.

Phase I Study Moving Along

The Phase I clinical trial was announced in March, 2020 and can be seen in the Chinese clinical trial registry (interestingly the website was down at the time of this writing)! The Phase I clinical trial is expected to end December 2020. The single center, open-label, dose-escalating Phase I clinical trial investigates the antibody response in healthy patients between the ages of 18 and 60 who will receive one of three doses, with follow up taking place at weeks 2 and 4 and months 3 and 6 post-vaccination. The study has enrolled 108 subjects.

The Phase II Study

The company recently published the study in the U.S. clinical trials registry as an active, enrolling, Phase II, randomized, double-blinded and placebo-controlled clinical trial in healthy adults over 18 years of age. The study was designed by the sponsors to evaluate the immunogenicity and safety of the Ad5-nCoV vaccine—which encodes for a full-length spike (S) protein of SARS-CoV-2.

With a target of 500 participants, the sponsors will enroll 250 of the subjects in a middle-dose vaccine group, 125 subjects in a low-dose and 125 subjects in the placebo group. They will investigate the immunogenicity at days 0, 14, 28 and 6 months after vaccination.

The Phase II Collaborative

This major Chinese study involves the core industry sponsor—CanSino Biologics, Inc. as well as their co-sponsor the Institute of Biotechnology, Academy of Military Medical Sciences—part of China’s People’s Liberation Army. Research sites include the Hubei Provincial Center for Disease Control and Prevention in Wuhan, Hubei Province, China. Other participants include the Jiangsu Province Centers for Disease Control and Prevention, the Hubei Provincial Center for Disease Control and Prevention and the Zhongnan Hospital.

The study’s Principal Investigator is Fengcai Zhu, MD, with the Jiangsu Province Centers of Disease Control and Prevention.

The Company

CanSino Biologics (CanSinoBIO) was established in Tianjin, China in 2009. Currently at 450 employees,  they have succeeded in producing one approved vaccine for Ebola virus disease (Ad5-EBOV) and 16 vaccine candidates in the pipeline.  Listed on the Hong Kong Exchange and Clearing Limited (HKEx) since March 2019, they focus primarily on the R&D of new vaccine candidates. The company’s senior team possess considerable Western “Big Pharma” pedigree including backgrounds from AstraZeneca, Wyeth (Pfizer) and CNBG (China). In possession of core intellectual property in the form of four key platform technologies, the company continues to develop their adenovirus-based viral vector vaccine as well as conjugation, protein structure design and recombination and vaccine formulation technologies. Additional intellectual property is being accumulated via various collaborations with research sites and startup ventures.

Vaccine Pipeline

Inclusive of the COVID-19 vaccine now in Phase II, they are developing a number of vaccines including 13 for infectious diseases.

R&D

The company maintains an 120,000 square-foot R&D center and 380,000 square-foot commercial manufacturing campus which was designed, qualified and operated according to international cGMP standards (e.g. FDA, EU, WHO and China). They report that their current production capacity can produce up to 70 million to 80 million doses in support of their commercialization quest.

Business & Finance

They recently went public and TrialSite News links to their Prospectus.

Licensing Deals

In-Licensing

The company reached out to Canada’s McMaster University in 2011 to ink an in-license deal for its tuberculosis vaccine candidate—specially using the technology in relation to their TB Booster candidate for what looks to be a good deal  at CAD105,000 ($75,000) of which CAD65,000 as paid as well as a royalty payment in the “low-single digits of the net sales of the licensed product. Additionally they partnered with the National Research Council of Canada (NRC) granting the Chinese company a non-exclusive license in the field of viral vector production for any of their products resulting from using NRC Technology (293SF-3F6 Cell Line Master Cell Bank). In this deal CanSino Biologics paid a “one-off” licensing fee in the “low-six figures” in 2014.

Out-Licensing

In 2009, 2011 and 2015 the company licensed their “PCV technologies” to Sinovac (a Chinese company).CanSino Biologics negotiated to receive milestone payments up to $1.8 million from Sinovac, all of which have been fully paid.

Academy of Military Medical Sciences’ Institute of Biotechnology

The Academy of Military Science of the Chinese People’s Liberation Army is a Chinese military medical research institute. It was established in Shanghai in 1951. It has been based in Beijing since 1958.

Lead Research/Investigator for the Phase II Study

Fengcai Zhu, MD, Jiangsu Province Centers of Disease Control and Prevention

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Source: CanSino Biologics Inc.

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