Photo Source: Sechenov University
Sechenov University will begin preclinical trials of the first Russian cell-based drug using TIL therapy, a form of cellular immunotherapy that employs the patient’s own T‑lymphocytes to fight tumors. The first indication will be melanoma resistant to standard treatments.
In TIL therapy (from tumor-infiltrating lymphocytes), the cells are pre‑trained against the antigens of the patient’s specific tumor before being administered. This fundamentally distinguishes the method from another advanced treatment for oncohematological diseases—CAR‑T therapy—where T‑lymphocytes are genetically modified to recognize a specific target.
The Sechenov University project is funded under the strategic technology program “Cell as a Medicine”. According to the university, a license for the production and use of autologous cell-based products was obtained in 2025.
Preclinical trials on laboratory animals are scheduled to begin in summer 2026, with completion expected by early 2027. Following this, the therapy may become available for the first patients with resistant forms of melanoma. In the future, the developers plan to adapt the TIL therapy platform for the treatment of bladder cancer, lung cancer, and other solid tumors.
TIL therapy is already used abroad: in February 2024, the FDA approved the world’s first TIL product, lifileucel (Amtagvi), for the treatment of advanced melanoma when other treatment options have been exhausted. The response rate was 31.4%, with some patients achieving complete tumor regression. Before lifileucel, these patients had essentially no approved treatment options with proven efficacy.
According to the Hertsen Moscow Oncology Research Institute, 11,605 new cases of melanoma were registered in Russia in 2023. The prevalence of the disease increased by 45.1% between 2012 and 2022. Melanoma accounts for about 4% of all malignant skin neoplasms but is responsible for up to 80% of skin cancer deaths.
Source: Vademecum
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