FOR THE FIRST TIME IN THE WORLD, APPROVAL HAS BEEN GRANTED FOR THE USE OF A PERSONALIZED MRNA VACCINE

Today, a unique event took place in Russian and global medicine – the National Medical Research Radiological Centre of the Minisrty of Health of the Russian Federation, together with the N.F. Gamaleya National Research Center for Epidemiology and Microbiology, received the world’s first approval for the clinical use of a personalized anti-tumor mRNA vaccine — “NEOONCOVAC”.

Personalized mRNA vaccines are a new generation of biotechnological drugs created based on the individual genetic profile of a specific patient’s tumor. Their goal is to ‘teach’ the immune system to recognize tumor cells and target them for destruction.
Until today, such drugs have only been available worldwide within the framework of clinical studies. The Russian decision to open the path to clinical use became possible thanks to the coordinated work of the Government of the Russian Federation and the Ministry of Health of the Russian Federation. The scientific framework for this field has been established by the Expert Council on Evolutionary Medicine and Medical Heritage at the Presidium of the Russian Academy of Sciences.

“Obtaining approval for the clinical use of “NEOONKOVAC” is the result of many years of systematic work and at the same time the beginning of a new era in personalized oncology. We are opening up the possibility of targeted action against tumors based on the genetic characteristics of individual patients. This is a big step forward, but we are aware of the scale of responsibility and will proceed as carefully and scientifically as possible”, –  said Andrey Kaprin, General Director of the National Medical Research Radiological Centre of the Ministry of Health of Russian Federation, and Academician of the Russian Academy of Sciences.

“At the initial stage, “NEOONKOVAC” can be used in adult patients with inoperable or metastatic cutaneous melanoma – in combination with immunotherapy. Or as a standalone therapy after surgical treatment of cutaneous melanoma, when all metastatic lesions have been removed, but also in combination with immunotherapy. Each of these options requires strict adherence to prescription conditions and monitoring of patient safety,” explains Petr Shegay, Deputy Director for Science at the National Medical Research Radiological Centre of  of the Ministry of Health of Russian Federation.

We are at the forefront of a new direction and are moving along it steadily and cautiously. The procedure for obtaining a personalized mRNA vaccine will be explained in detail later – we will definitely provide additional information on this.