In a groundbreaking announcement that could revolutionize cancer treatment worldwide, Russian health officials have declared that the Enteromix mRNA-based cancer vaccine is ready for clinical use following successful preclinical trials. The vaccine, developed by the Federal Medical and Biological Agency (FMBA) in collaboration with leading Russian research institutes, promises personalised immunotherapy tailored to individual patients’ genetic profiles.
This development marks a significant milestone in oncology, leveraging mRNA technology similar to that used in COVID-19 vaccines, but optimised for combating tumours. The revelation came during the Eastern Economic Forum (EEF) in Vladivostok on September 6, where FMBA head Veronika Skvortsova detailed the vaccine’s progress.
Skvortsova said that over the past three years, regulated preclinical studies have confirmed Enteromix’s high safety and efficacy, even with repeated administrations. “The vaccine has demonstrated significant results in shrinking tumors and slowing their growth,” she stated, highlighting its potential to extend patient survival rates.
Enteromix represents an innovative approach to cancer immunotherapy, utilising messenger RNA (mRNA) to instruct the body’s immune system to target and destroy malignant cells. Unlike traditional vaccines, it is personalized, each dose is customised based on the patient’s unique tumour RNA profile, employing artificial intelligence (AI) to identify neoantigens, which are specific mutations in cancer cells that can be exploited for immune recognition.
This precision allows the vaccine to activate antitumour immunity, effectively training T-cells to attack tumours while minimizing damage to healthy tissue. The technology draws from platforms proven in COVID-19 vaccines but adapts them for oncology. Preclinical trials, conducted on animal models, focused on colorectal cancer as the primary target, with variants in development for aggressive forms like glioblastoma (a type of brain cancer) and certain melanomas (skin cancer).
Collaboration among institutions, including the National Medical Research Radiological Centre, the Engelhardt Institute of Molecular Biology, and the Gamaleya Research Institute (known for the Sputnik V COVID-19 vaccine), has accelerated development.
The project builds on earlier Russian advancements in oncology vaccines, with preclinical data from late 2024 showing promising results against melanomas and metastases.
Preclinical results have been overwhelmingly positive. In trials involving models of colorectal cancer, Enteromix achieved tumour reduction rates of 60-80%, with some sources reporting up to 100% success in eliminating tumours and activating innate immunity.
he vaccine’s safety profile is equally impressive, showing no adverse effects even after multiple doses, a critical factor for long-term cancer management. Documents for clinical approval have been submitted to Russia’s Ministry of Health, with Phase I human trials set to begin imminently, involving up to 48 participants.
If approved, Enteromix will be provided free of charge to Russian citizens, a move announced by Health Minister Mikhail Murashko and oncology chief Andrey Kaprin earlier this year.
