The Russian Ministry of Healthcare issued a permit to the Nacimbio holding of the Rostec State Corporation to conduct clinical trials of the first in Russia and the second in the world combined vaccine for the prevention of influenza and coronavirus infection - Ultrix Combi. The safety and tolerability of the drug will be tested in 370 patients. The drug is being developed by Nacimbio together with the biotechnology company Artgen Biotech (MOEX: ABIO).
The permit was issued to conduct phase I-II clinical trials, during which it is expected to study the safety, immunogenicity and tolerability of the Ultrix Combi vaccine. To obtain the permit to conduct clinical trials, the necessary amount of preclinical research was carried out in accordance with international requirements.
“The combined preventive drug will allow us to respond to the challenges facing healthcare and related to the control of respiratory viral diseases. Both influenza and Covid can cause significant damage to both economy and public health in a short time. Our joint project with the Artgen Biotech group is designed to significantly reduce the negative social and economic effects created by these diseases. We are starting the most important stage of work on the vaccine. A double-blind, placebo-controlled clinical trial will show the effects of the vaccine in the human body and evaluate its effectiveness,” said Andrey Zagorsky, CEO of Nacimbio.
The Ultrix Combi vaccine contains components developed by Nacimbio to protect against four seasonal strains of influenza viruses, as well as a component that provides protection against the SARS-CoV-2 virus. The antigen for immunization against covid and the technological platform on which the vaccine is created were developed by the companies of the Artgen Biotech group - Biotechnology Developments (RBT) and Betuvax.
“The introduction of the combined vaccine into the vaccination schedule will reduce the total healthcare costs of vaccination against influenza and Covid separately, increase the effectiveness of the vaccine campaign and increase population immunity, which, in general, will prevent the development of pandemics. Despite the fact that the WHO has canceled the pandemic status for coronavirus, the incidence of covid is at a high level, and the current mortality rates from covid exceed mortality from influenza,” Artur Isaev, Artgen Biotech Chairman of the Board of Directors, said.
“National Immunobiological Company” is a pharmaceutical holding created by the Rostec State corporation in 2013 with the aim of developing the production of immunobiological drugs important for national security. It unites key Russian pharmaceutical enterprises - Microgen Research and Development Company and FORT Biopharmaceutical Company (10 production sites in total). The scope of activities of Nacimbio includes the development, full-cycle production and sale of vaccines and toxoids of the current and future National Schedule of Preventive Vaccinations, blood products, bacteriophages, allergens, allergoids and other drugs. The holding's product portfolio includes more than 220 types of medicines.
Rostec State Corporation is the largest engineering company in Russia. It unites over 800 scientific and production organizations in 60 regions of the country. The company acts as a key supplier of weapons, military and special equipment within the framework of State defense orders. It develops high-tech civilian production in strategically important industries for the country, such as aircraft manufacturing, engine building, transport and energy engineering, medical instrument making, pharmaceuticals, new materials, etc. Consolidated revenue in 2023 exceeded 2.9 trillion rubles.