Overview

• FMBA chief Veronika Skvortsova announced at the Eastern Economic Forum that Enteromix completed mandatory preclinical studies and is awaiting Health Ministry approval.
• Developers report 60–80% tumor shrinkage or slower progression in study models, improved survival, and a favorable safety profile with repeated dosing.
• Regulators have received an approval dossier, and a Phase I study of about 48 participants is described as imminent, with some reports saying early human testing has begun.
• Enteromix is a personalized mRNA neoantigen vaccine that uses AI to tailor each dose to a patient’s tumor profile, with colorectal cancer as the first target and glioblastoma and certain melanomas in development.
• Russian and international outlets have floated a 100% success claim that has not been independently verified, and experts say larger, controlled human trials are essential before drawing conclusions.