The first patient with colorectal cancer has begun receiving a personalized peptide therapeutic vaccine called Oncopept, Russia’s Federal Medical-Biological Agency (FMBA) told GxP News. The patient has already received three doses of the drug, which have demonstrated good tolerability. The FMBA granted approval for clinical use of the vaccine to treat this disease in November 2025. The technology uses bioinformatic analysis of the tumour’s genetic material to retrain the patient’s immune system to precisely destroy their cancer cells.
The drug was first administered to the patient on March 31 this year, the agency said. A vaccine has also been prepared for the next participant and is scheduled to be administered on April 20.
Under the clinical use program for Oncopept, 543 applications have already been processed and 24 patients selected for treatment, the FMBA said. Manufacturing a single dose of the vaccine takes 49 days, including at least seven days for quality control. The agency added that standard preclinical trials are also underway for personalized cancer vaccines targeting glioblastoma and melanoma.
In early April, a personalized mRNA vaccine called NeoOncovaс was used for the first time in Russian clinical practice, the agency noted. The drug was given to a 60-year-old resident of the Kursk region with skin melanoma. At the time, it was reported that synthesis of the vaccine had begun for a second patient.
It was later announced that the government had added treatment courses with personalized mRNA vaccines, the Oncopept vaccine, and CAR-T therapy to the compulsory health insurance program. Previously, such technologies were available only through research studies or on a commercial basis. The move will expand patient access to these treatment methods.
According to a draft document published in March, treatment with mRNA vaccines will be lengthy and carried out in several stages, necessitating separate financial cost standards, the report said. Only federal clinics with appropriate equipment will be able to provide the new types of care.