The European Medicines Agency (EMA) has granted Immunicum AB (STO: IMMU) an Advanced Therapy Medicinal Product (ATMP) certificate for its lead product candidate, ilixadencel, following a review of manufacturing quality and non-clinical data, the company announced on Tuesday.

Ilixadencel is an off-the-shelf cancer immune primer that was developed for the treatment of solid tumours. The active ingredient is allogeneic dendritic cells and, via intratumoral injection, these cells generate an inflammatory response which leads to tumour-specific activation of the patient's cytotoxic T-cells.

ATMP certification provides a structured assessment and guidance to small and medium-sized enterprises (SMEs) developing advanced therapies, which include cell and gene therapies, as well as tissue-engineered products.

At the end of an evaluation, the EMA may issue a certificate upon the recommendation of the Committee of Advanced Therapies (CAT), confirming the quality of the manufacturing process and preclinical data submitted for ATMP review.

An ATMP certificate is not essential for a future application for marketing authorisation, however, it does affirm that manufacturing quality and non-clinical development have met regulatory guidelines, taking into consideration the stage of product development.