The mRNA-based vaccine is entirely individualised. "The drug is entirely personalized, created specifically for each patient using their unique tumor data, and cannot be used for anyone else," Gintsburg said.
According to RT, development of the vaccine began in mid-2022. It uses messenger RNA (mRNA) and artificial intelligence to design customised treatments based on a patient’s genetic tumour profile. The therapy works by training the immune system to detect and destroy malignant cells using cytotoxic lymphocytes.
Due to its personalised nature, the vaccine falls under a separate regulatory process created by the Russian government earlier this year. “This is a fundamentally different process from the registration of standard drugs,” Gintsburg noted, adding that the team is working closely with the Health Ministry under the new guidelines.
The production cycle — from analysing tumour data to producing the vaccine — takes about a week with AI support, Gintsburg said. The vaccine has already shown promising results in animal studies and limited human trials.
Initially targeted at melanoma patients, the vaccine model is also being extended to other cancers including pancreatic, kidney, and non-small-cell lung cancer, which Gintsburg described as among the most difficult to treat.
According to Russia's Health Ministry, there are approximately 4 million cancer patients in the country, with 625,000 new diagnoses each year. If proven safe and effective, the new vaccine could mark a milestone in Russia’s personalised medicine programme. Gintsburg also said that "several foreign medical institutions have reached out to express a desire to collaborate."
In December last year, Russian health authorities announced that the mRNA-based cancer vaccine would be distributed free of cost to Russian citizens, with an estimated production cost of 300,000 rubles (USD 2,869) per dose. Andrey Kaprin, head of the Radiology Medical Research Centre under the Health Ministry, said at the time, "This vaccine aims to treat cancer patients rather than prevent tumour formation." The personalised vaccine uses tumour-derived genetic material to activate the immune system against cancer-specific antigens.
Similar mRNA-based vaccines are undergoing trials in the US and UK, including early-stage studies in glioblastoma and melanoma that have shown encouraging immune responses and improved survival outcomes.