Vaccine Maker Shopping for a Country to Conduct Phase 3 Clinical Trial: Prospects Look Increasingly Dim

Jul 13, 2020 | Ad5-nCoV, CanSino Biologics, COVID-19, Investor Watch, News, Vaccine

Vaccine Maker Shopping for a Country to Conduct Phase 3 Clinical Trial Prospects Look Increasingly Dim

Vaccine maker CanSino Biologics, at one point the leading vaccine developer in pursuit of a COVID-19 vaccine, continues to slip behind the competition, and recently, its co-founder and director announced the company’s discussions with various countries to conduct a Phase 3 clinical trial. While on the domestic front, the Chinese government has volunteered its military for an exclusive one year use, the reality is that COVID-19 cases have gone down in that country, where the pathogen originated from, due more than likely to lax wet market public health standards. Moreover, domestically, two other vaccines have moved into Phase 3 including Sinovac and a unit China National Pharmaceutical Group (Sinopharm), hence making the domestic field probably too crowded.  Therefore, the company’s look overseas and thus far only a few countries are even willing to entertain talking to them.

At a recent anti-viral drug development conference in Suzhou, in eastern China, executive director and company co-founder Qiu Dongxu shared that the company was in discussions with  Russia, Brazil, Chile and Saudi Arabia and that thus far only a few countries have agreed to work with the firm.  They face challenges due to 1) lack of domestic interest and demand, 2) competition from abroad, and 3) possible market concerns about the company and investigational product. Thanks to the reporting by Roxanne Liu in Suzhou and Tony Munroe in Beijing, Reuters covered this conference and verified other local sources.  Although the product was essentially “approved” for limited use by the Chinese military, the Motley Fool’s Alex Carchidi points out that “Between the vaccine’s small population of eligible recipients, its limited efficacy, and its intense side effects, nobody seems to be clamoring to license it for manufacturing outside China.”

China Dilemma

Although the Chinese military is co-developing the Ad5-nCov investigational vaccine, and as mentioned, the product has been approved in Chinese for wide scale use by the Chinese military for a year, the company faces fierce domestic competition due not only to dramatically less COVID-19 cases in China but also intense domestic competition from both Sinovac and Sinopharm. Consequently, Chinese interest wanes in Ad5-nCov. There just doesn’t seem to be enough interest or demand on the home front for CanSino Biologics even though the Chinese military’s research and development operation helped to develop the product. 

Competition

CanSino Biologics faces fierce competition overseas as major pharmaceutical companies have inked deals with promising candidates for not only co-development in clinical research but also manufacturing and worldwide distribution. To initiate their Phase 3 clinical trial involving up to 40,000 volunteers, they must sign up other countries to participate. But other vaccine developers are also talking to those same nations’ sites. Hence at the recent conference, the company’s director declared the Phase 3 would start “pretty soon.”

What could become apparent from unfolding dynamics worldwide: that unless Ad5-nCov is head and shoulders above the competition, CanSino Biologics is not equipped to compete against major “pharma,” such as AstraZeneca (AZD1222 developed by Oxford and testing in South Africa and deal with Brazil) or Pfizer (BNT162 developed by  Germany’s BioNTech).  Johnson and Johnson will also move into the discussions soon (see below).  

Moreover, the U.S. government’s Operation Warp Speed, if executed strategically, intelligently and holistically, will make market access for CanSino Biologics even more difficult. That U.S.-based firms are receiving large sums of money to develop vaccines makes life more difficult for the CanSino Biologics as their clinical operations will compete for sites worldwide. While Moderna (mRNA-1273) received $483 million and heads to Phase 3 soon, Inovio Pharmaceuticals (INO-4800) secure $71 million and Novavax just received a staggering $1.6 billion while it already has a Phase 1 beachhead in Australia. The competition for sites and licensing deals becomes extremely difficult.  

Moreover, there are nearly a couple dozen candidates in clinical trials, including emerging products from India and Japan. Russia has announced it has a government-funded domestically developed candidate in the pipeline as well. The point here is that these countries will more than likely favor their domestically produced product unless CanSino Biologics’ product is superior.

Also, other dangerous competitors lurk in the background; for example, Johnson and Johnson (J&J) and subsidiary Janssen have introduced Ad26.COV2-S which is headed for Phase 1 clinical trials. Although behind the others in terms of timeline, this global operation centered around the intellectual property developed by Janssen’s AdVac® technology cannot be discounted.

Market Concerns?

Actual concerns about the investigational product mount as well. Acknowledging some questions about their Phase 1 clinical trial results for Ad5-nCov, Mr. Qiu Dongxu told members at the recent conference in Suzhou that the safety and immunogenicity data arising out of the Phase 2 clinical trial involving Ad5-nCov was much better than the Phase 1 results. According to multiple press source coverage of the event, including Reuters, there were no specifics shared which raises a red flag to some. Typically at a conference full of scientists and physicians, one with good news usually comes armed with at least some data to substantiate positive claims. 

As reported by TrialSite News, CanSino Biologics was able to secure a deal with Canada (the founders worked there and the actual idea for the company was conceived of in Canada). However, growing political tensions between the countries could be influencing a major clinical trial. That the delivery of the investigational product to the trial site could be delayed due to political tensions, if true, will certainly further spook research-oriented markets away from the company.

Finally, the company director shared something odd with the audience at the conference in Suzhou, noting that a discussion should commence as to launch emergency inoculation of experimental vaccines “right now.” What does he mean by emergency inoculation? Already the Chinese government has volunteered at least some of its members. Does he mean the testing of the rank and file troops?  Who else could he be referring to? If this is what he said, it reeks of desperation.

Conclusion

CanSino Biologics will face a harder road ahead in bringing its investigational vaccine product to the market. Will the combination of market concerns (product, et al), competition, and lack of domestic interest ultimately eliminate the prospects for Ad5-nCov?

Source: Reuters

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