Elicera Therapeutics

The dose-escalation study, conducted in collaboration with Uppsala University as the co-sponsor, consists of two parts: a dose-escalation study (Phase I) with 12 patients, which is now complete, 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.

No dose limiting toxicities have been reported in Phase I. The Data Safety and Monitoring Board (DSMB) has, after reviewing the safety data, recommended the highest dose level as the Phase IIa dose. Once approval from the Swedish Medical Products Agency (MPA) has been received, Phase IIa patients will be treated at the highest dose level.

The latest data reported from the CARMA study, press released on August 11, showed that among the eleven patients evaluated, all had achieved disease control (no disease progression) one month after treatment, and 91 percent (10/11) had obtained an objective tumor response, including six patients (55 percent) with complete metabolic response (disease-free status). Of these, four patients remained disease-free, one for at least 18 months and one for at least 12 months. The company will provide an update of preliminary efficacy data from all 12 patients in the Phase I-part of the study when the final patient in Phase I has undergone the one-month evaluation.
 

“Built on the accumulated efficacy signals we have seen so far in Phase I, the DSMB's positive recommendation strengthens our confidence in ELC-301. We can now proceed with the Phase IIa part of the CARMA study as soon as possible after MPA approval. This brings us one step closer to offering a new treatment option to patients with limited alternatives. I look forward to sharing the complete Phase I data in due course", says Elicera’s CEO, Johan Liwing.