Moscow, August 4, 2025 — The Gamaleya National Research Center, renowned for developing the Sputnik V COVID-19 vaccine, has announced a bold new frontier in oncology: human trials of an AI-designed, personalized mRNA cancer vaccine will begin by September–October 2025. The trials will initially focus on melanoma patients, with plans to expand to include non-small-cell lung, kidney, and pancreatic cancers.
This cutting-edge treatment will be provided free of charge to patients, with the Russian government funding the full cost—estimated at 300,000 rubles per dose.
🧬 Personalized Medicine Meets Artificial Intelligence
Unlike preventive vaccines, this therapeutic cancer vaccine is designed to treat existing tumors by targeting tumor-specific neoantigens—genetic mutations unique to each patient’s cancer. What makes this effort groundbreaking is the use of AI neural networks to personalize the mRNA vaccine for each individual.
According to the Gamaleya Center, the process—starting from tumor DNA sequencing to finalizing the mRNA blueprint—can take as little as 30 minutes to one hour, with most cases completed within a week. This rapid turnaround could drastically reduce the time required to begin treatment, a critical factor for aggressive cancers.
🧪 Pre-Clinical Success and Trial Details
Pre-clinical animal trials and limited early-phase human data have reportedly shown significant tumor suppression and reduced metastasis. The upcoming trials will be conducted under accelerated regulatory approval frameworks at top Russian oncology institutions, including the Hertsen Institute and Blokhin Cancer Center in Moscow. Gamaleya will manage vaccine production in-house.
📊 Scope and Potential Impact
With an estimated 4 million cancer patients and 625,000 new cases annually, Russia faces a pressing public health challenge. If successful, this initiative could mark a revolutionary shift in cancer treatment, not only domestically but globally.
Here’s a quick summary of key details:
| Item | Details |
|---|---|
| Developer | Gamaleya Research Center, Moscow |
| Vaccine Type | Personalized mRNA targeting tumor neoantigens |
| AI Role | Uses neural networks to design vaccine in <1 hour to 1 week |
| Clinical Start | September–October 2025 |
| Target Cancers | Melanoma, lung, kidney, pancreatic |
| Cost to Patients | Free (Govt-funded at ~300,000 rubles/dose) |
| Regulatory Status | Trials approved under special cancer research framework |
| Key Institutions | Hertsen Institute, Blokhin Cancer Center |
🌍 Global Competition and Skepticism
Russia’s move enters a highly competitive and cautious global race. Moderna, BioNTech, and Merck are already conducting Phase 1/2 trials for similar mRNA-based cancer therapies, particularly in melanoma.
However, international experts remain skeptical of Gamaleya’s claims due to the lack of peer-reviewed data and scientific transparency. Dr. Sanjay Singh of Gennova Biopharmaceuticals emphasized that until clinical data is published, the broader medical community cannot verify efficacy or safety.
🚀 Why This Matters
This marks one of the world’s first human trials of an AI-powered, personalized mRNA cancer vaccine, potentially cutting development time and scaling precision oncology. If proven successful, it could redefine how cancer is treated—swiftly, accurately, and affordably.
