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Pressemeddelelse

Elicera Therapeutics Continues Phase I/IIa CARMA Study with CAR T-Cell Therapy as Planned Following Safety Committee's Assessment in Cohort 2

Elicera Therapeutics

Gothenburg, August 25, 2025 - Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on oncolytic viruses and CAR T-cell therapies, armed with immune-activating properties via the company's commercially available iTANK platform, announced today that the Data Safety and Monitoring Board (DSMB) has completed its second assessment of the ongoing Phase I/IIa CARMA clinical study with the CAR T-cell therapy, ELC-301, for the treatment of B-cell lymphoma. The DSMB recommended the continuation of the study as planned.

The dose-escalation study, conducted in collaboration with Uppsala University as the sponsor, consists of two parts: a dose-escalation study (Phase I) with 12 patients and a dose-expansion study (Phase IIa) with 6 patients. The cell therapy ELC-301 incorporates the iTANK platform technology, which, through its parallel immune activation, aims to provide a broader and more effective attack on cancer cells.

The latest data report from the CARMA study, presented at the 7th Swedish Cancer Research Meeting in Malmö on May 22, showed promising preliminary results from the first dose cohort. Of the three patients treated with the lowest dose level, equivalent to one-tenth of the planned maximum dose, two achieved a complete metabolic response, meaning no active lymphoma was detected in imaging-based scans. This includes one patient who had previously stopped responding to a CD19-targeted CAR T therapy, reinforcing ELC-301's potential, particularly for this difficult-to-treat patient group. No serious adverse events were reported.

Following the Data Safety and Monitoring Board's (DSMB) recommendation to continue the study, treatment of patients in the third and final cohort with the highest dose level in the dose-escalation study can now commence.

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