Artgen Biotech's Board of Directors decided to continue independent development of a combined vaccine for the prevention of influenza and coronavirus infection by Biotechnology Developments (RBT), the group's company, and to terminate the agreement on joint development of the combined vaccine with Nacimbio Pharmaceutical Holding.
Such a decision was made because of no progress in the development of the drug and delayed arrangement and conducting of clinical trials of the new vaccine.
The agreement between Nacimbio and Artgen Biotech on the joint development of a combined vaccine was made on December 27, 2022.
The combined pentavalent vaccine is based on Betusphere adjuvant platform by RBT (part of Artgen Biotech group). It contains four influenza antigens produced by Nacimbio and an original recombinant antigen against coronavirus infection — SARS-CoV-2 developed by Betuvax (also part of Artgen Biotech group).
Before starting cooperation with Nacimbio, RBT and Betuvax biotechnological companies developed and patented SARS-CoV-2 COVID antigen, Betuvax-Cov-2 coronavirus vaccine, Betusphere adjuvant, influenza vaccine, and a combined pentavalent influenza and coronavirus vaccine.
RBT and Betuvax financed and completed the full scope of preclinical studies of the combined vaccine in May 2023. According to their results, the drug demonstrated safety, immunogenicity and protection in conformity to international requirements.
In October 2023, Nacimbio submitted a package of documents to the MoH of Russia to obtain authorization for phase I–II clinical trials of the drug. Nine months later, on July 3, 2024, the MoH of Russia authorized the clinical trials of the drug by Nacimbio with a deadline of December 31, 2024.
RBT intends to rearrange the dossier, obtain authorization by the MoH of Russia for clinical trials of the combined vaccine, and conduct them.
Igor Viktorovich Krasilnikov, RBT's General Director: “We highly appreciate the scientific and industry potential of Nacimbio as a partner and count on further cooperation in terms of supply of antigens, contract manufacturing of the vaccine and its inclusion in the national immunization schedule”.