he Uppsala-based company says the agency has approved a substantial modification to the clinical trial authorization, allowing the study to move on to its dose-expansion phase. CARMA is co-sponsored by Uppsala University and conducted at Akademiska Hospital in Uppsala and Karolinska University Hospital in Huddinge.

ELC-301 incorporates Elicera’s iTANK platform, which is designed to trigger a parallel immune response for a broader attack on cancer cells. No dose-limiting toxicities were reported in Phase I, and the study’s independent Data Safety and Monitoring Board recommended the highest dose level for Phase II.

In the latest data update, published August 11, all eleven treated and evaluable Phase I patients had achieved disease control. Ten of them (91%) had an objective tumor response, and six (55%) reached complete metabolic response, or disease-free status, as their best response. Four of the six were still in complete response at the last follow-up, and two had been confirmed disease-free for at least twelve and eighteen months, respectively.

“The approval to move CARMA into Phase IIa is an important milestone for Elicera. It means our clinical teams can now begin treating patients at the dose we have identified as optimal, building directly on the depth and durability of response we have already seen in Phase I,” says Johan Liwing, CEO of Elicera.