Russia is preparing to launch clinical trials of its first AI-assisted, personalized cancer vaccine within the next few months, according to Alexander Gintsburg, head of the Gamaleya Research Institute of Epidemiology and Microbiology. The groundbreaking mRNA-based vaccine is designed to target malignant tumors using each patient’s unique genetic profile.

Gintsburg told RIA Novosti that the experimental treatment phase will begin soon in partnership with two major oncology centers in Moscow — the Hertsen Research Institute and the Blokhin Cancer Center. While the Gamaleya Institute will produce the vaccine, the clinical trials will be carried out by these partner institutions.

The vaccine, which is tailored specifically to each patient based on neoantigens found in their tumors, will first be tested in melanoma patients. Using mRNA technology, the treatment trains the patient’s immune system to detect and destroy cancer cells by identifying tumor-specific proteins.

Due to its personalized nature, the vaccine falls under a new regulatory framework implemented by the Russian government earlier this year, streamlining the approval process for individualized treatments. Gintsburg emphasized that this approach is fundamentally different from traditional drug registration.

Development of the vaccine began in mid-2022 and has already shown promising results in both animal studies and limited human tests. Remarkably, the entire process—from tumor analysis to vaccine creation—can be completed in roughly one week, thanks to artificial intelligence.

Following the melanoma trials, the Gamaleya Center is also working on similar treatments for pancreatic, kidney, and non-small-cell lung cancers — some of the most deadly and difficult-to-treat forms of cancer.

With around 4 million cancer patients and over 600,000 new diagnoses annually in Russia, the vaccine has the potential to become a major milestone in the country’s healthcare system. The innovation has drawn international attention, with several foreign medical institutions expressing interest in collaborating on the project.