Spot-on: melanoma vaccine to be tested on patients in fall 2025
The first patients may receive a Russian vaccine against melanoma as early as next fall. This was announced to Izvestia by Alexander Gintsburg, Director of the Gamaleya Research Center of Epidemiology and Microbiology. N.F. Gamalei Alexander Gintsburg. In the future, the technology will be extended to other cancer diseases. Experts consider the chosen approach very promising, but note that production of such therapies is very difficult to enter practical medicine.
When the melanoma vaccine will be available to patients
The task of developing a vaccine against cancer is being solved jointly with specialists from the N.N. Blokhin Oncology Research Center. N.N. Blokhin, P.A. Herzen MNIOI, said the director of the N.F. Gamaleya Research Center of Epidemiology and Microbiology. N.F. Gamaley Research Center of Epidemiology and Microbiology Alexander Gintsburg. Combining the methods will make it possible to apply the new vaccines to treat patients next fall, as planned according to the road map, which has now been approved by the Ministry of Health on this task for 2025.
According to him, it will no longer be clinical trials, as the vaccine being developed is a personalized medicine, but will be obtaining approval for the use of this technology.
- In August-September 2025, we should obtain this permission to use the technology, develop a drug for the first patients and start injecting it into specific patients. We can also say that we hope to form a consortium of institutes as soon as possible, because we understand perfectly well that it is wrong to limit ourselves to one model of melanoma. We need to expand this technology to other cancers. First of all, small cell cancer. For example, lung cancer, pancreatic cancer, kidney cancer and so on," Alexander Gintsburg said in a conversation with Izvestia.
According to him, for this purpose it is necessary to involve other specialized research institutes in the consortium in order to work out the use of the vaccine together with them, by analogy with melanoma, on other models of cancer diseases.
How the cancer vaccine works
As Alexander Gintsburg explained, at an early stage a melanoma model was created on mice. This model showed the effectiveness of a vaccine created using mRNA technology based on melanoma neoantigens. These are mutations in the melanoma tumor that are specific to this pathological tissue. It has been shown that such an immunobiologic treatment method can suppress not only malignancies, but apparently even secondary foci that can arise as a result of cancer growth, the scientist said.
- But this was already some time ago. And now the main task is to combine this technology with classical methods of cancer treatment. First of all, with the technology of control of checkpoint inhibition (so-called P1-inhibition, which allows more effective cytotoxic CD8 lymphocytes to destroy cancer cells) and chemotherapy, - explained Gintsburg "Izvestia".
In order to select a personalized drug for each patient, biopsy material will be taken from the patient. biopsy material will be taken from the tumor and normal tissue, then it will be necessary to sequencing their genome. Next, using computer analysis, these two genetic sequences are compared to detect mutations that are specific to the tumor tissue.
- Then based on these point mutations, an informative mRNA structure is selected that combines the nucleotide sequences that contain these mutations into a single structure. And when they enter the patient's body, they synthesize mRNA peptides, which are antibodies that carry the corresponding changes in the amino acid sequence specific to that tumor. And the immune system begins to recognize these sequences as a foreign antigen, and with the help of cytotoxic t-lymphocytes, these tumor cells will be destroyed," said the director of the Gamaleya Center.
Personalized cancer treatment
We are talking about a vaccine based on matrix RNA (mRNA), this is an innovative approach for the treatment of cancer, explained Albert Rizvanov, head of the Center of Excellence "Personalized Medicine" of Kazan (Volga Region) Federal University, corresponding member of the Academy of Sciences of the Republic of Tatarstan.
- Such a vaccine trains the immune system to recognize and destroy cancer cells. Moreover, it can destroy not only the original tumor, but even micrometastases, even single cells that circulate in the blood, as the immune system penetrates all tissues of the body," the expert noted.
The approach of mRNA vaccines, which was proposed by scientists from the Gamaleya Research Center for Epidemiology and Microbiology. N.F. Gamaleya Research Center for Epidemiology and Microbiology, is very advanced and integrates many discoveries of recent years in the field of the immune system and how it fights cancer, said Andrei Lomonosov, deputy head of the NTI HealthNet working group in the direction of "Biomedicine", scientific consultant of R-Pharm JSC, in a conversation with Izvestia.
- The developed technology of mRNA vaccines, which offers to train the immune system to recognize a tumor, is quite capable of producing similar results. However, there are limitations. Chief among them: 100% personalization. Each vaccine must be made for not just a specific patient, but for their tumor. And that may be the main difficulty. We already have an example of super effective personal cell therapy for the treatment of oncohematologic diseases (CAR-T therapy), and the experience of its application has shown very significant challenges for the production of personalized drugs," said the expert.
Here we have to talk about a complete paradigm shift in drug supply: from one pill "for everyone" to a separately produced drug for each patient, the expert emphasized. And the process includes obtaining a tumor, its complete sequencing to determine the spectrum of neoantigens, prediction of the most significant ones and on the basis of these selected dozens of sequences to create a mRNA vaccine. And only then - its administration to the patient.
Therefore, technologically the process itself is quite feasible, but organizationally and industrially such therapies are very difficult to enter practical medicine, emphasized Andrei Lomonosov.
