The breakthrough treatment is expected to get regulatory approval by August, according to the head of the Gamaleya Research Institute
A breakthrough personalized cancer vaccine developed by Russia’s Gamaleya Research Institute could receive regulatory approval as early as this summer, potentially allowing patients to begin treatment in September, the institute’s director Alexander Gintsburg has told RIA Novosti.
“According to the roadmap plan that we submitted to the Ministry of Health, although it has not yet been finally approved, we will likely receive permission at the end of August so that we can begin treating people in September,” Gintsburg told the news agency.
The Gamaleya Research Institute of Epidemiology and Microbiology had previously developed Sputnik V, world’s first registered Covid-19 vaccine. In 2022, the center applied mRNA technology, the basis for other Covid vaccines, to develop a new type of cancer drug.
In an interview with RT last month, the Gamaleya chief explained that the new drug is a therapeutic vaccine designed to be administered to those already diagnosed with cancer. It causes the patient’s immune system to start destroying malignant cells. The shot enables Cytotoxic lymphocytes, or white blood cells, that appear in the body of a vaccinated person to recognize foreign proteins (antigens) on the surface of tumor cells. Cytotoxic lymphocytes then find foreign, metastasizing cells and destroy them throughout the body.
In a statement to RIA, Gintsburg noted that while there are several cancer drugs currently being developed in Russia, the Gamaleya vaccine will be tailor-made for each patient and developed with the help of artificial intelligence. Gintsburg specified that AI will be used to analyze the parameters of the tumor and issue a “blueprint” for the drug which will then be used by specialists to create a customized vaccine within about a week.
While the vaccine is intended for patients diagnosed with primary melanoma, it can also be administered to people who have undergone certain stages of treatment, Gintsburg has said.
Gintsburg has previously noted that the vaccine has performed well in treating mice using an animal model of melanoma and that as many as seven human patients have already undergone the treatment.
The Gamaleya center is also currently developing models for treating other oncological diseases, including pancreatic, kidney and non-small-cell lung cancer, which reportedly is the most frequently diagnosed cancer with the highest mortality rate and is notoriously difficult to treat, according to Gintsburg.
In 2023, Russia’s Ministry of Health reported 4 million cancer patients in the country. Andrey Kaprin, director of the National Medical Research Center for Radiology under the Ministry of Health, estimated that around 625,000 new cancer cases are diagnosed annually in Russia, with an expected increase in incidence by 2030.
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