Cancer Relapse Vaccine Candidate Receives Advanced Classification
Immunicum AB announced on June 28, 2021, that it had received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for the Company’s lead cancer relapse vaccine candidate, DCP-001.
The EMA and the Committee for Advanced Therapies have concluded that DCP-001 meets the ATMP classification criteria and classifies it as a somatic cell therapy medicinal product. The ATMP classification provides further guidance regarding the regulatory path forward for DCP-001.
DCP-001 is derived from Immunicum’s proprietary human DCOne cell line. It is currently being evaluated as a cancer relapse vaccine to prevent 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 the residual disease.
DCP-001 has been developed using Immunicum’s expertise in allogeneic dendritic cell biology, resulting in a highly immunogenic vaccine carrying multiple endogenous tumor-associated antigens, which have the potential to boost the immune system to control residual disease and prevent or reduce tumor recurrence. It has demonstrated an excellent safety profile in clinical studies. It is currently evaluated in an ongoing international Phase II clinical trial in acute myeloid leukemia patients and a Phase I clinical trial in patients with High-Grade Serous Ovarian Cancer.
Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm.