NATIONAL MEDICAL RESEARCH RADIOLOGICAL CENTRE: FIRST CLINICAL EXPERIENCE OF USING AN MRNA VACCINE

At the P. Hertsen MORI — a branch of the National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation – the first clinical experience of using a personalized anti-tumor mRNA vaccine “NEOONKOVAK” was conducted on a patient with skin melanoma. The implementation of the project was made possible thanks to the systemic support of the Government and the Ministry of Health of the Russian Federation, as well as existing regulatory decisions that ensured the possibility of accelerated introduction of personalized drugs into clinical practice: “Starting today, the clinical application of this latest technology to save lives, by the order of the Chairman of the Government of Russia Mikhail Vladimirovich Mishustin, we are completing the work on its inclusion in the state guarantees program. Thus, this breakthrough treatment technology will soon become available to the citizens of our country who require such treatment for medical reasons,” said the Minister of Health of the Russian Federation Michail Murashko.

Today, “NEOONKOVAK” can be used as a therapy for the treatment of adult patients with unresectable or metastatic cutaneous melanoma in combination with immune checkpoint inhibitors (ICIs), as well as for adjuvant therapy after surgical treatment in adult patients with cutaneous melanoma in combination with ICIs.

The project was implemented in collaboration with the National Medical Research Radiological Centre of the Ministry of Health of Russian Federation and the Gamaleya National Center of Epidemiology and Microbiology.

“NEOONKVAK” is a personalized mRNA vaccine that is created individually for each patient based on the molecular-genetic characteristics of their tumor. The drug contains information about specific tumor antigens, which allows the patient’s immune system to be “tuned” to recognize and destroy tumor cells, including microscopic foci of the disease. The first patient was a 60-year-old resident of the Kursk region diagnosed with “skin melanoma.” The disease was detected in 2021, and the patient underwent surgical treatment. In 2025, progression with lymph node involvement was recorded, after which a repeat surgical intervention was performed at the P. Hertsen MORI. The patient is currently undergoing immunotherapy. Despite the ongoing treatment, there remains a high risk of further progression, and standard options will be extremely limited. In these conditions, the use of a personalized mRNA vaccine is considered as a means of controlling the disease.

The preparation of the drug is carried out individually, including the final stage in the GMP laboratory of NMRRC immediately before administration. “Today we are at a point where oncology is becoming truly personalized. We applied an mRNA vaccine created for a specific patient. This is a fundamentally different approach — not just treating the disease, but ‘teaching’ the immune system to recognize and destroy exactly those cells that pose a threat. Importantly, thanks to government support, we managed to develop a regulatory model that allows such technologies to reach the patient as quickly as possible. A significant role in implementing this approach was played by the personal stance of the Minister of Health of the Russian Federation Mikhail Albertovich Murashko, which ensured institutional support for the project and its practical implementation”, – comments the General Director of the NMRRC, academician of the Russian Academy of Sciences Andrey Dmitrievich Kaprin. — On the condition of a successful ‘launch’ of the drug for the treatment of skin melanoma, we, of course, will be considering the possibility of expanding the indications for the use of such vaccines”.

“From the point of view of the development itself, we tried to incorporate all the best that exists. These are the best genetic constructs, the best genetic elements. We carried out extensive preparatory work. Our team includes the Institute for System Programming — these are the best mathematicians, so we also implemented the best software solutions in this development. And, in fact, the Gamaleya Center has many years of experience in producing various vaccine products, and we now have a large production complex on the Center’s premises for the production of mRNA vaccines — not only oncological but also anti-infectious. Only such a consortium of different competencies, primarily oncological competencies, allowed us to reach the application of this drug,” noted the director of the Gamaleya National Center of Epidemiology and Microbiology, academician of the Russian Academy of Sciences, Denis Yuryevich Logunov.