Russian Petrovax Embraces Ad5-nCoV & Brings into Russia for Phase 3 Clinical Trials

Russian Petrovax Embraces Ad5-nCoV & Brings into Russia for Phase 3 Clinical Trials, a Russian pharmaceutical company has inked a deal with CanSino Biologics (CanSinoBIO) to drive Phase 3 clinical trials in Russia. The two have agreed to come together and “cooperate” on the testing of the COVID-19 vaccine called Ad5-nCoV, one that was developed by both the CanSinoBIO and the Beijing Institute of Biotechnology, Academy of Military Medical Science  Ad5-nCoV was recently approved for Chinese military use (despite no Phase 3 clinical trial in China) while the SARS-CoV-2 vaccine moves into commencement Phase 3 in various nations around the globe, including now Russia. Based on the language of recent comments from the CEO of Petrovax, the parties have been working on the collaboration for some time now. It would appear that Russia is diversifying to not just be dependent on its Sputnik V COVID-19 vaccine. Although the Russian authorities recently approved Sputnik V, developed by the Gamaleya Institute, and also prepare for mass inoculations starting with at-risk populations, the nation clearly seeks alternative options; hence why one of its top five biotech firms, held by one of the most powerful of Russian oligarch-owned conglomerates, makes the investment to conduct expensive Phase 3 clinical trials in Russia. Clearly, Petrovax will seek a return on its investment and that means wide-scale use in Russia and beyond.

COVID-19 in Russia

With nearly one million reported COVID-19 cases, Russia is one of the hot spots of COVID-19 infections worldwide: followed by the United States first, Brazil second, and India in the number three spot. Russia has experienced far less mortality (16,383 reported), however TrialSite cannot confirm whether national reporting statistics are accurate. Moreover, Russia has obvious concerns, as do the rest of the world’s nations, as to the impact on its fragile political economy. TrialSite has reported recently that Russia’s embrace of the war against COVID-19 must dovetail with its driving life science industrial policy

Vaccines and Geopolitical Dynamics

It would appear that vaccine nationalism could be leading to vaccine “regional blocs,” where various groupings of nations select certain vaccines from certain origin countries. TrialSite recently showcased that the top 10 wealthiest economies, as measured by GDP, are overwhelmingly selecting vaccines produced in either the U.S., the UK and Germany. Hence “Western” bloc, a “Sino” or now a “Sino-Russian” bloc, while these groupings will both also contribute to non-governmental organizational (NGO) distribution channels for lower income nations such as the GAVI COVAX Facility

Canada was one of the Western nations that inked a national co-development deal with a Chinese firm (CanSinoBIO).  The deal went embarrassingly south when the investigational product was delayed in customs indefinitely, a sign of growing political tensions between Canada and China as well as, of course, Canada’s allegiances to the United States and the growing tension between America and China. Since then, Canada was forced to a Plan B

Closer Russia & China Vaccine Development

At a recent symposium, a top Chinese respiratory expert named Zhong Nanshan touted that both China and Russia have been planning joint clinical development and trials of the vaccine. Apparently, this symposium brought together experts from both nations seeking to optimize “bilateral cooperation on COVID-19 containment” in a bid to accelerate “progress in their fight against COVID-19.” In a recognition that the two are tightening up their collaboration, Zhong suggested that both China and Russia “have much to learn from each other.” 

This news touted both Russia’s low fatality rate (1.7 %) with China’s “unique methods of fighting the epidemic, especially in applying traditional Chinese medicine.”

Phase 3 Locations.

CanSino Biologics faced a challenge initially in finding locations for Phase 3 clinical trials as the COVID-19 pandemic waned in China while sufficiently checked in many other parts of southeast Asia. The Beijing and Hong Kong-based company faces competition from other Chinese producers such as Sinovac in countries such as Indonesia and against possibly Sputnik V in the Philippines. As reported by TrialSite and others, the company reported serious talks in a number of countries interested in participation, including Saudi Arabia, Russia, Brazil, Mexico and Chile. TrialSite suggested breakthroughs recently occurred in Saudi Arabia as the Kingdom geared up to conduct clinical trials. 

Ad5-nCoV Patient Granted in China

Recently, TrialSite reported that the Chinese national government in Beijing granted the Ad5-nCoV a patent, the fist for a COVID-19 vaccine in China. The China National Intellectual Property Administration reported that on August 11, 2020 the patent was assigned to the venture that was initially conceived of in Canada by a group of smart, dedicated and ambitious Chinese nationals. TrialSite suggested, however, that a combination of science, politics and business execution challenge could dilute the strength of that latest milestone—the patent award.

The First Foreign Vaccine to Enter Russia

Now a new first as the very first foreign-produced vaccine is now being accepted by Russia’s government. As Petrovax confirmed just on Saturday that would conduct a Phase 3 clincial trial for CanSino Biologics, Russia now prepares the entire nation for mass production for domestic administration of the Sputnik V vaccine developed by Moscow’s Gamaleya Institute.

Petrovax & CanSinoBIO POV

Mikhail Tsyferov, President of Petrovax Pharm, recently noted in the joint press release, “COVID-19 response is an absolute priority for Petrovax in 2020. We strive to apply long standing experience accumulated by our company in developing and producing vaccines for the benefit of the whole society. Our company is pleased to cooperate with CanSinoBIO, one of the world leaders in developing a vaccine against coronavirus infection. Our teams worked hard for many months to launch the Phase 3 clinical trial; this is an example of an international partnership that gains momentum and includes more and more countries.”

CEO and Chairman Xuefeng Yu reported they were “delighted” with the partnership and the need for “multi-national collaboration” in supporting the product’s efficacy and contribution to broad distribution.

Petrovax: Part of a Conglomerate

As reported in their LinkedIn profile, Petrovax has operated for over two decades as a “full-cycle biopharmaceutical company,” representing as a “top-5 immunobiological manufacturer in Russia.” The company develops its own intellectual property as well as generics and vaccines. Centered in the Moscow area, its manufacturing facilities and processes adhere to GMP standards as well as ISO:0991. The company positions itself as one of the most technologically sophisticated firms in Russia. Moreover, it declares that it was the first immunological manufacturer in Russia to secure GMP certification by the European Union. In relation to the EU, the company declares it has formed partnerships with leading American and European pharma from Pfizer and Abbott to privately held German drug maker Boehringer Ingelheim.

Now the company markets it and successfully competes among world leaders, not only domestically (Russia and former Soviet Bloc nations) but also in the Middle East and Eastern Europe. With 600 skilled employees, the company is owned by Interros Group

The Interros Group is a Russian conglomerate owned by oligarch Vladimir Potanin who made a fortune in mining, metals, energy, finance, and other dealings. Based in Moscow, that holding company was founded by Mr. Potanin and Mikhail Prokhorov, the latter departing in 2007 receiving $7.5 billion for his interest. According to Forbes, Mr. Potanin is worth $23.7 billion.