Russia’s Gamaleya National Research Center—best known for developing the Sputnik V COVID-19 shot—has confirmed that it will launch Phase I clinical trials of a personalized mRNA cancer vaccine by September-October 2025. The first cohort will involve melanoma patients treated at Moscow’s Hertsen Research Institute and the N.N. Blokhin Cancer Center.
AI-Designed and Patient-Specific
Unlike conventional “one-size-fits-all” therapies, the new vaccine is custom-built for each patient. Artificial-intelligence algorithms sequence a tumor’s DNA, identify unique neo-antigens, and generate a bespoke mRNA blueprint that trains cytotoxic lymphocytes to hunt down malignant cells. Gamaleya says the entire process—from biopsy to finished vial—takes about one week.
Free Access for Russian Citizens
The Health Ministry has placed the program under a special fast-track regulatory pathway and plans to cover the estimated ₽300,000 (≈ US $2,900) cost per dose, making the therapy free of charge for domestic patients. Officials view the effort as a flagship for Russia’s wider push into individualized oncology.
What Happens Next
-
Trial scope: Initial safety and dosing data will be gathered from a small group of melanoma patients; additional tumor types—pancreatic, kidney and non-small-cell lung cancers—are slated for later phases.
- International interest: Gamaleya director Alexander Gintsburg says several foreign cancer centers have inquired about collaborative studies, hinting at future multi-country trials.
- Timeline: If Phase I results are positive, broader efficacy studies could begin in 2026, with limited compassionate use possible sooner, according to Russian media reports.