Cylembio (melanoma vaccine)

History

2025: Product Announcement

In mid-August 2025, IO Biotech announced the release of the combination vaccine Cylembio for the treatment of advanced melanoma. Patients receiving such therapy show improved progression-free survival.

Melanoma is a malignant formation that develops from melanocytes - pigment cells that produce melanins. This is an aggressive type of tumor whose cells spread intensively throughout the body, forming distant metastases. Since the early 1970s, the incidence of malignant melanoma has increased significantly (for example, in the United States it increases by an average of 4% per year). The results of numerous scientific studies indicate that the risk of malignant melanoma is in certain dependence on the genetic predisposition and individual properties of the body, as well as on the effect of UV radiation on humans. It is estimated that in 2022 there were about 1.5 million people with skin melanoma in the United States alone.

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Фото: Freepik

In a study involving more than 400 patients, the Cylembio vaccine was used together with Merck Keytruda (an immuno-oncological agent for the treatment of malignant tumors, a PD-1 inhibitor). In people who received such combination therapy, the condition did not worsen for an average of 19.4 months, compared with 11 months in those who received Keytruda alone.

IO Biotech says the combination vaccine is well tolerated and shows no new safety signals. In addition, there was a trend towards improved overall survival. In the fall of 2025, IO Biotech plans to meet with representatives of the U.S. Food and Drug Administration (FDA) to discuss the possibility of using Cylembio.^[1]

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