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.