Pharmsynthez PJSC, a Portfolio Company Owned by RUSNANO, HiFiBio Therapeutics, and IBC RAS Reached an Agreement about Jointly Developing Monoclonal Antibodies to Help Prevent and Treat COVID-19, and Producing Them in Russia

23 November 2020

Pharmsynthez PJSC, the Russian Academy of Sciences Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry (IBC RAS), and the international biopharmaceutical company HiFiBio Therapeutics signed an agreement pursuant to which its parties will unite their expertise to conduct clinical trials on, produce, and make commercial deliveries of the monoclonal antibody HFB30132A to the Russian market to help prevent and treat the SARS-CoV-2 coronavirus infection. This treatment method will be used in Russia for the first time.

Previously, this project was presented during a meeting between representatives from Pharmsynthez PJSC, HiFiBio, the IBC RAS, the Russian Federation Ministry of Healthcare, and the Russian Federation Ministry of Industry and Trade; further development work on it inside the Russian Federation was approved by the relevant Russian industry agencies.

The human monoclonal antibody HFB30132A was developed as part of joint efforts put forth by HiFiBio Therapeutics, Nankai University (in the PRC), Shanghai Technical University, the Wuhan Institute of Virology (also in the PRC), and scientists from the IBC RAS; they used technologies to clone and decode the genomes in single B cells from the blood of patients who have survived COVID-19. The mechanism by which HFB30132A takes action consists of binding the spike protein and neutralizing the SARS-CoV-2 virus, including its mutant form, D614G, which is capable of spreading rapidly. It is anticipated that using HFB30132A as monotherapy to help prevent COVID-19 will cause fewer side effects, and boost activity in the lungs and upper respiratory tract mucosa when compared to the typical monoclonal antibodies used in treatment. The results following a study done in the United States on the first cohort of healthy volunteers have already been obtained for phase I of a dose escalation study (NCT04590430) in which HFB30132A demonstrated high-level results for safety, tolerability, and pharmacokinetics. Plans for the near future include transnational clinical trials on patients in high-risk categories that have shown asymptomatic, mild, or moderate progression for COVID-19.

“The coronavirus infection pandemic has become a challenge for the entire modern healthcare industry. RUSNANO already has projects in the field of testing systems to help diagnose the SARS-CoV-2 virus, and for related disorders with the blood coagulation system. We are now concentrating our efforts on another crucial objective—innovative COVID-19 therapy,” states Anatoly Chubais, the Chairman of the Board for RUSNANO Group “The antibodies that prevent the disease from penetrating into the cell are a joint development produced by several world-level research centers, including the Russian Institute of Bioorganic Chemistry. And we think it is extremely important to help make this innovative treatment available to citizens in our country,” he underscored.

“The second wave of COVID-19 has shown that there is an urgent need to create immunobiological drugs that have a direct effect on the SARS-CoV-2 virus,” stated Kirill Mayorov, the president of Pharmsynthez PJSC. “As an innovative development company, we develop promising, high-technology projects that provide a safe, efficacious level of protection against diseases, including for patients with high-risk factors. This antibody can both help combat the active coronavirus infection and prevent the whole cascade of serious complications that we see around the world today. Taking into account the gravity of the epidemiological situation, Pharmsynthez PJSC will do everything in its power to ensure the swift advent of HFB30132A into the arsenal possessed by the Russian healthcare industry,” stated the company’s president.

As part of this partnership, Pharmsynthez PJSC will conduct a multi-center, randomized, double-blind, placebo-controlled, two-stage clinical trial to evaluate the pharmacokinetics, immunogenicity, safety and efficacy for HFB30132A in patients with COVID-19 in the Russian Federation, and will gain the exclusive rights to manufacture the drug and bring it to the Russian pharmaceutical market. Production of the monoclonal antibodies is slated to be organized using the manufacturing capacity on-site at the RAS Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry.

“We are happy to be working with Pharmsynthez PJSC and the IBC RAS, taking advantage of their experience and resources to successfully develop and introduce this innovative treatment to patients in Russia,” stated Jeff He, Chief Operating Officer at HiFiBio Therapeutics. “This strategic partnership demonstrates our open, innovative approach, as well as the global collaboration needed to respond quickly to the challenges of a global pandemic,” he stated.

This new international partnership also boosts the potential for a scientific and technological alliance to arise between Pharmsynthez PJSC and the IBC RAS. “In conjunction with developing a recombinant, composite, genetically engineered vaccine against SARS-CoV-2, which has been accomplished together with the IBC RAS and Pharmsynthez PJSC, setting up a facility to manufacture the neutralizing antibody to work against the SARS-CoV-2 virus helps create a unique portfolio that offers complete immunobiological coverage for the SARS-CoV-2 infection: preventive vaccinations, emergency immunoprophylaxis and immunotherapy,” stated Aleksandr Gabibov, the director of the Institute of Bioorganic Chemistry. “The results of scientific research done in the world today suggest that the first generation of vaccines created to prevent SARS-CoV-2 infection will probably not be able to fully control the spread of the SARS-CoV-2 virus. Under these conditions, expanding the arsenal of specific immunotherapy targeted at the SARS-CoV-2 infection becomes vital,” the academician underscored.

To help put the project in place involving creating the monoclonal antibody, Pharmsynthez PJSC registered a new company called JSC VAKTSINI. Besides this project, the company will be involved in developing other innovative, original products by Pharmsynthez PJSC, including a high-priority project to design its own in-house vaccine to combat the coronavirus.

Additional information

Reference

Pharmsynthez PJSC (Saint Petersburg) is a public joint-stock company that develops and produces pharmaceutical substances and medicinal products, both as part of its own product range and under conditions that involve contract manufacturing. It has a unique production facility in Leningrad Region. Pharmsynthez PJSC is the parent company in a holding company whose key assets are Xenetic Biosciences (USA), the formulator of a range of promising medicinal products whose shares are traded on the NASDAQ stock exchange (ticker symbol XBIO), and Kevelt AS (Estonia), a GMP-certified developer and producer of medicines for the US, European, and CIS markets. Shares in Pharmsynthez PJSC are admitted for trading on the Moscow Exchange in the Innovation and Investment Market (IIM) section (ticker symbol LIFE). The RUSNANO Group is the majority shareholder in Pharmsynthez PJSC.

For more information about the company, visit en.pharmsynthez.com