Elicera Therapeutics

The CARMA study evaluates the safety and efficacy of ELC-301 in patients with relapsed or refractory B-cell lymphoma. The study includes a dose-escalation phase (Phase I, 12 patients) and a dose-expansion phase (Phase IIa, 6 patients). ELC-301 utilizes the iTANK platform to activate a broader immune response against cancer cells.

The primary aim of the Phase I study is to investigate the safety of ELC-301. No severe or unexpected adverse events have been observed in the first two cohorts, and the study's independent Data Safety Monitoring Board has therefore recommended that the evaluation of ELC-301 can proceed to the third and final dose cohort, where six patients will receive the maximum planned dose (10 times Cohort 1).

Professor Magnus Essand, Chief Scientific Officer and co-founder of Elicera Therapeutics, will present the data today at the inauguration of the Karolinska ATMP Center in Flemingsberg, Sweden. Preliminary data assessed by the principal investigator include:

Cohort 1 (Lowest dose, 1/10 of planned maximum dose, n=3):
· Two patients achieved complete metabolic response (CMR, no active disease) at the one-month follow-up (month 1). One patient later showed progressive disease at the 3-month follow-up, while the other remained disease-free at the 9-month follow-up.
· One patient showed stable disease at month 1, followed by progressive disease at the 3-month follow-up.

Cohort 2 (Three times the lowest dose, n=3):
· Two patients achieved CMR at month 1, with one patient having completed the 3-month follow-up and remaining disease-free.
· One patient achieved partial response at month 1, which persisted at the 3-month follow-up.

"We are highly encouraged that 4 out of 6 patients in the first cohorts with low doses achieved complete metabolic response, including one patient who previously relapsed on CD19-targeted CAR T-cell therapy," said Jamal El-Mosleh, CEO of Elicera Therapeutics. "These early data underscore the potential of our iTANK-armed ELC-301 to offer a new treatment option for patients with difficult-to-treat B-cell lymphoma."