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Immunicum receives Advanced Therapy Medicinal Product classification

The company has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for the company’s lead cancer relapse vaccine candidate, DCP-001.

DCP-001 is derived from Immunicum’s human DCOne cell line and is currently being evaluated as a cancer relapse vaccine for the prevention of tumor recurrence in two ongoing clinical studies addressing acute myeloid leukemia and ovarian cancer. DCP-001 is administered as an intradermal vaccine and has been shown to trigger systemic immune responses against different tumor-associated antigens, potentially contributing to the immune system’s control over residual disease.

The EMA and the Committee for Advanced Therapies (CAT) have concluded that DCP-001 meets the ATMP classification criteria and classifies as a somatic cell therapy medicinal product. The ATMP classification provides further guidance regarding the regulatory path forward for DCP-001.

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