The personalized mRNA cancer vaccine NeoOncovac will have strictly defined clinical use cases, state news agency TASS reported, citing Andrey Kaprin, chief oncologist at the health ministry and head of the National Medical Research Centre for Radiology.
Initially, the vaccine is authorized for use in adults with non-operable or metastatic skin melanoma, where it will be administered in combination with immunotherapy, Kaprin said. A second use case could be as a continued therapy after surgical removal of melanoma metastases to reduce the risk of recurrence. “In all cases, we are talking about clear indications and strict safety controls,” he added.
Kaprin noted that until now, all such personalized mRNA vaccines had existed only within the scope of clinical trials. These next-generation biotech drugs are created based on an individual patient’s tumor genetic profile and are designed to train the immune system to recognize and destroy cancer cells.
In late November, the Russian Ministry of Health authorized two individualized biotechnological drugs for clinical use: the mRNA-based cancer vaccine NeoOncovac and a peptide vaccine for colorectal cancer called Oncopept.
The approval for NeoOncovac covers its use at the Centre for Radiology and the Gamaleya Centre. Earlier this month, it was reported that the mRNA production facility at the Gamaleya Centre had completed its first three test batches of the cancer vaccine.
