Razvitiye Biotechnologii (“Development of Biotechnologies”) (RBT) has submitted documents to the Ministry of Health of the Russian Federation for obtaining permission to conduct clinical trials of a new influenza vaccine. Preclinical studies of the drug were conducted on the basis of I.I.Mechnikov Scientific Research Institute of Vaccines and Serums and the Smorodintsev Research Institute of Influenza.
Earlier, the Human Stem Cell Institute (HSCI) and RBT signed an investment agreement to become co-investors in the development, preclinical and clinical research of a new line of adjuvants and vaccines. Among other things, these include a tetra-valent influenza vaccine and a vaccine against the human papillomavirus.
RBT is a company engaged in the implementation of a platform for the creation of antiviral candidate vaccines based on recombinant proteins placed on nanoparticles. In preclinical studies, the platform has shown a high safety profile and the necessary level of immunogenicity and effectiveness. The developers of the project are a team of scientists who have good experience and competence in the field of vaccine development. Vaccines with a corpuscular carrier have been developed since 2016.
According to Igor Krasilnikov, who is the developer and RBT’s co-founder and CEO, the new flu vaccine is a virus-like particle with antigens of four strains of the influenza virus sorbed on its surface. This is a quadrivalent vaccine intended for the epidemiological season of 2021-2022.
“Unlike other vaccines available on the market, our product does not contain extraneous proteins, and the antigen content in it is three times lower. Due to this, the vaccine has a low reactogenicity. According to preclinical studies, it produces a wide range of antibodies with a high titer. In the context of the ongoing coronavirus pandemic, vaccination against seasonal influenza is especially great, since a person may be infected with both viruses at the same time, which can lead to serious health consequences,“ Igor Krasilnikov said.
In partnership with Betuvax (part of the HSCI group), RBT has developed Betuvax-Cov-2, a vaccine against coronavirus infection. Clinical trials of Betuvax-Cov-2 can start in September 2021 after the Ministry of Health of the Russian Federation issues the corresponding permit.
RBT also creates vaccines against influenza and human papillomavirus.