The Gamaleya National Research Center, best known for developing Russia’s Sputnik V COVID‑19 vaccine, has announced plans to start human trials of an AI‑designed personalized mRNA cancer vaccine by September–October 2025, focusing initially on melanoma and possibly expanding to other cancers like lung and kidney cancer. Treatment will be offered free to patients.
⚙️ How It Works: Rapid AI‑Driven Personalization
- The treatment is therapeutic, not preventive, aimed at treating existing tumors via a personalized mRNA vaccine that targets tumor-specific neoantigens.
- Using AI neural networks, the vaccine design—from tumour DNA sequencing to mRNA blueprint—can be completed in around a week, and in some cases within 30 minutes to one hour.
🧪 Pre‑Clinical Success & Trial Design
- Animal studies and limited early human trials demonstrated tumor suppression and reduced metastases
- Curry protocols approved under special regulatory frameworks will allow trials at leading Russian oncology centers—Hertsen Institute and Blokhin Cancer Center in Moscow—with the Gamaleya Center handling production.
📋 Trial Scope & Target Cancers
- Initial trials will involve melanoma patients, with plans to expand to non‑small-cell lung, kidney, and pancreatic cancers.
- Given Russia’s estimated 4 million cancer patients and 625,000 new cases per year, if successful, the vaccine may represent a significant national medical breakthrough.
🌍 Global Context & Scientific Skepticism
- Similar mRNA‑based cancer vaccines by Moderna, BioNTech, and Merck are already in Phase 1/2 trials globally, showing promising results particularly in melanoma.
- However, many experts remain cautious due to the lack of published clinical data or peer-reviewed trial results from Russian sources. As Dr. Sanjay Singh of Gennova Biopharmaceuticals noted, without transparent scientific evidence, these claims cannot be verified.
🧾 Summary Table
| Item | Details |
|---|---|
| Developer | Gamaleya Research Center, Moscow |
| Vaccine Type | Personalized mRNA based on tumor neoantigens |
| AI Role | Designs vaccine in <1 hour to 1 week using neural networks |
| Clinical Trial Start | September–October 2025 |
| Target Cancers | Melanoma, NSCLC, kidney, pancreatic cancers |
| Cost to Patients | Free (~300,000 rubles per dose funded by government) |
| Scientific Concerns | Lack of published data; need for rigorous validation |
🧠 Why It Matters
This initiative marks one of the first attempts to bring AI‑designed personalized mRNA cancer vaccines into human trials. If successful, it could accelerate global momentum in precision oncology, reduce production times, and make personalized cancer treatments more scalable.
That said, the scientific community emphasizes caution until trial results are publicly shared and peer-reviewed. Even among seasoned researchers, there’s consensus that extraordinary claims require equally rigorous evidence before being widely embraced.The Economic Times
