Within the next 1 to 1.5 months, the first patients will receive an experimental domestic mRNA vaccine against melanoma, the most aggressive form of skin cancer, said Aleksandr Ginzburg, the Director of the N. F. Gamaleya National Research Center of Epidemiology and Microbiology.
“The documents required for obtaining permission to produce personalized vaccines for cancer therapy have been submitted, volunteer groups for treatment have been formed, and their genetic data has been collected. “We are ready to begin treatment within 1 to 1.5 months,” he stated during the round table titled The History of Russian Leadership in the Field of Medical Science and Technology.
According to Ginzburg, there is hope that “soon, the Herzen Institute, the Blokhin Institute, and our [Gamaleya] Institute will obtain approval to produce the initial types of personalized melanoma vaccines.”
As the expert explained earlier, personalized biologics developed based on a specific patient’s genetic data and intended solely for their treatment require special regulation.
Considering these features, a decree was passed in February that establishes a special legal regime for such personalized biologics. Their production is conducted directly within medical institutions, and clinics must obtain special authorization from the Ministry of Health to both manufacture and administer these drugs.
