28 June 2021
Immunicum Receives Advanced Therapy Medicinal Product Classification from the EMA for Cancer Relapse Vaccine Candidate DCP-001
Immunicum AB (publ) today announced that it 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 proprietary 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.
DCP-001 is an “off-the-shelf”, cell-based cancer relapse vaccine candidate based on Immunicum’s proprietary DCOne cell line and manufacturing process. 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 and is currently evaluated in an ongoing international Phase II clinical trial in acute myeloid leukemia (AML) patients, as well as a Phase I clinical trial in patients with High-Grade Serous Ovarian Cancer (HGSOC).
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Executive Officer
Telephone: +31 713 322 627
Head of Investor Relations & Corporate Communication
Telephone: +46 8 732 8400
Eva Mulder and Sophia Hergenhan
Telephone: +49 175 222 57 56
ABOUT IMMUNICUM AB (PUBL)
Immunicum is leveraging its unparalleled expertise in dendritic cell biology to develop novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. With complementary therapeutic approaches in Phase II clinical development that are based on intratumoral priming and cancer relapse vaccination, the company aims to improve survival outcomes and quality of life for a broad population of cancer patients. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com