Russia's National Medical Research Radiological Centre (NMRRC) has officially launched Phase I clinical trials for EnteroMix, a novel cancer vaccine that harnesses four non-pathogenic viruses to combat malignant tumors. The announcement was made by NMRRC Director General Andrey Kaprin during the St. Petersburg International Economic Forum, marking a significant milestone in Russia's oncology research efforts.
Trial Design and Patient Recruitment
The first-in-human study is designed as an open-label, single-center Phase I clinical trial, with NMRRC serving as the authorized institution to conduct the research. According to Kaprin, the trial has already recruited 48 volunteers and is actively underway. The vaccine has demonstrated very low toxicity levels during its transition from preclinical to clinical testing.
Mechanism of Action
EnteroMix represents an innovative approach to cancer immunotherapy, utilizing a combination of four non-pathogenic viruses as its therapeutic foundation. These viruses are engineered to perform a dual function: directly destroying malignant cells while simultaneously activating the patient's anti-tumor immune response. This dual mechanism aims to create a comprehensive anti-cancer effect that leverages both direct viral oncolysis and enhanced immune system activation.
Preclinical Development and Efficacy
The vaccine successfully completed several years of preclinical trials before advancing to human testing. During these studies, EnteroMix demonstrated a range of therapeutic effects, from slowing tumor growth to achieving complete destruction of cancer cells. Kaprin emphasized that the vaccine's effects span this broad spectrum, suggesting potential efficacy across different stages of cancer progression.
Regulatory and Development Context
The clinical trial launch was announced during the St. Petersburg International Economic Forum (SPIEF 2025), which took place from June 18 to 21 in northern Russia. The event, organized by the Roscongress agency under the Russian President's office, provided a platform for highlighting Russia's advances in medical research and biotechnology development.
The progression of EnteroMix from preclinical studies to Phase I trials represents a significant step forward in viral-based cancer immunotherapy research. The vaccine's unique four-virus platform distinguishes it from other oncolytic virus therapies currently in development, potentially offering a new therapeutic paradigm for cancer treatment.
