Elicera Therapeutics submits GMP validation data to the Swedish Medical Products Agency for the CARMA study to supplement the conditionally approved clinical trial application

Gothenburg, December 22, 2023 – Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on its proprietary commercial technology platform iTANK, today announced that it has submitted complementary data to the Swedish Medical Product Agency (MPA) that validates the GMP-level production standard of the CAR T-cell therapy ELC-301. The data package is submitted to meet the MPA’s request for additional information which was queried in its conditional approval of Elicera Therapeutic’s clinical Phase I/IIa study CARMA.

In January 2023, Elicera Therapeutics submitted a Clinical Trial Application (CTA) to the MPA to conduct a clinical Phase I/IIa study (CARMA) aimed at evaluating the safety and efficacy of ELC-301, a CD20-directed iTANK-armed CAR T-cell therapy, in patients with relapsed and/or refractory B-cell malignancies. In April, the company received a conditional approval from the MPA, requesting complementary data to validate the production process of ELC-301 according to GMP standards. Elicera Therapeutics has now generated preclinical validation data, confirming high and consistent quality of its active pharmaceutical substance, and submitted the complementary information to the regulatory agency. The MPA will now review the data, for a period of maximum 14 weeks, and subsequently inform the company whether it can initiate the Phase I/IIa study CARMA or if additional data is needed.

"We are glad to have finalized our validation of ELC-301 and achieved a production process worthy of GMP standards. Next, we look forward to the MPA’s hopefully speedy review of our full clinical trial application and aim to be able to initiate the CARMA study in the first part of 2024,” says Jamal El-Mosleh, CEO of Elicera Therapeutics.

Elicera Therapeutic’s candidate therapy ELC-301 constitutes a fourth generation CAR T-cell therapy that targets the CD20 antigen, which is expressed on the cell surface of B-cell lymphoma cells. ELC-301 has been armed with iTANK to elicit a dual mode-of-action, partly via a direct cancer cell-killing effect by CAR T-cells, partly by activating the patients’ own killer T-cells against a wide array of target antigens. Thus, the patient’s killer T-cells are expected to target cancer cells independent of CD19 or CD20 expression