Russia is on its way to introduce its personalised mRNA-based cancer vaccine called Enteromix which has reportedly shown 100 percent efficacy and safety in early-stage clinical trials. The country's Federal Medical and Biological Agency (FMBA) announced last week that the vaccine not only proved to be safe but also showed powerful tumour-fighting abilities. Sputnik, a global wire and digital news service from Russia on September 7 posted on X: "The Russian Enteromix cancer vaccine is now ready for clinical use, the Federal Medical and Biological Agency (FMBA) has announced."
At the Eastern Economic Forum (EEF), held between September 3 and 6, Veronica Skvortsova, head of Russia's FMBA, stated that the Enteromix vaccine is personalised for each patient, designed using their unique RNA profile. The first version of the vaccine, awaiting approval, is aimed at treating colorectal cancer -- one of the most prevalent and lethal cancers globally. Preclinical trials showed that the vaccine significantly reduced tumour size and slowed their progression.
It was also proven safe for repeated administration, is built on technology similar to Covid-19 mRNA vaccines, and is said to work without the harsh side effects of chemotherapy or radiation. Research is also progressing on additional variants of the vaccine, including those targeting glioblastoma, an aggressive and often fatal brain tumour, and specific forms of melanoma such as ocular melanoma. These developments could mark a major breakthrough in precision cancer therapy.
Enteromix was developed by Russia's National Medical Research Radiology Centre in collaboration with the Engelhardt Institute of Molecular Biology under the Russian Academy of Sciences. It was publicly unveiled at the St Petersburg International Economic Forum (SPIEF 2025), showcasing Russia's latest biotech innovations. Built on mRNA technology -- previously used in Covid-19 vaccines -- Enteromix trains the immune system to identify and attack cancer cells. It uses a combination of four harmless viruses to target tumours while activating immune defences. After years of preclinical testing, the vaccine has shown the ability to slow tumour growth and, in some cases, eliminate tumours entirely with its Phase-1 trials which began in June 2025 with 48 volunteers. The vaccine is awaiting regulatory approval, and if cleared, could become the world's first personalised cancer vaccine, offering tailored treatment and potentially transforming global cancer care.
Russia is not alone in the race to develop cancer vaccines. Biotech companies around the world, including BioNTech in Germany, Moderna in the US, and CureVac are actively testing personalised mRNA vaccines for cancers such as pancreatic, melanoma, and lung. Some of these firms have already reached Phase II or III clinical trials, giving them a lead in terms of data maturity and potential regulatory approvals in key markets like the EU and US. Two US cancer vaccines are reportedly under trial and will seek regulatory approval by end of 2026. Where the Russia vaccine is concerned, while Phase 1 results are promising, the vaccine needs to undergo larger, multi-center Phase 2 and Phase 3 clinical trials to confirm its effectiveness and safety in a broader population.