Elicera Therapeutics completes Phase I part of CARMA study of ELC-301 and reports complete metabolic response in 8 of 12 patients

"Completing the dose-escalation part of the CARMA study is a major milestone for Elicera. What stands out isn't just the high proportion of responding patients, but also the depth and durability of those responses in a population that had run out of viable treatment options. This includes patients who had relapsed after completed CAR T-cell therapy. Some patients in the study have now maintained their response for well over a year, which is an early but meaningful signal of durability. This strengthens our confidence in the potential of ELC-301 and the iTANK platform. We are now preparing for a full analysis of all the collected data from the Phase I part of the study, and patient recruitment to the Phase IIa part of the study, where we look forward to building further on these encouraging results," says Johan Liwing, CEO of Elicera Therapeutics.

"We're encouraged to see responses and a safety profile that support continuing the clinical development of ELC-301. Every signal of efficacy matters enormously in this setting. The patients enrolled in this trial have no remaining curative treatment options and, given their disease stage, would typically face a very limited life expectancy. That these early results have been achieved in such a difficult-to-treat population makes them particularly meaningful as we now move into Phase IIa," comments Gunilla Enblad, professor at the Department of Immunology, Genetics, and Pathology, senior consultant in oncology at Uppsala University Hospital, and clinical principal investigator for the CARMA study.

Key highlights from the Phase I part of the CARMA study

• Patients in the study have, in general, undergone extensive prior treatment, with several having received multiple lines of chemotherapy, stem cell transplantation and, in three cases, prior CAR T-cell therapy before entering the study.

• All twelve patients in the Phase I dose-escalation part have now been treated and evaluated for preliminary efficacy at least at the one-month follow-up
• No dose-limiting toxicities (DLT) have been observed across any of the three dose cohorts, and ELC-301 has continued to be well-tolerated.
• Promising, deep and durable response rates were observed:
   
  • Complete metabolic response (CMR; no active disease): 67% (8/12 patients).
  • Overall response rate (ORR; objective tumor response): 92% (11/12 patients). Three of the twelve evaluated patients had previously received CAR T-cell therapy but subsequently relapsed. After treatment with ELC-301, all three achieved disease control, of whom two obtained an objective tumor response, including one CMR.
  • Disease control rate: 100% (12/12 patients).
  • Of the eight patients who have achieved CMR as their best response to date, six remain in CMR at their most recent assessment; two later progressed after initially responding.
  • One patient has confirmed CMR for at least 18 months. Another patient has confirmed CMR for at least 12 months.

ELC-301 is a fourth-generation CAR T-cell therapy targeting the CD20 antigen, armed with the company's iTANK platform to activate a broader and more comprehensive parallel immune response against cancer.

The CARMA study is a clinical Phase I/IIa study evaluating the safety, optimal dosing, and preliminary efficacy of ELC-301 in patients with relapsed or refractory B-cell lymphoma who have undergone at least two previous lines of standard treatment and have no remaining curative treatment options. The study includes a dose-escalation phase (Phase I) with twelve patients across three cohorts to identify the maximum tolerated dose, followed by further evaluation of six patients in an expansion phase (Phase IIa).

The Swedish Medical Products Agency (Läkemedelsverket) has recently approved a substantial modification to the clinical trial authorization for the CARMA study, permitting the study to proceed into its Phase IIa part. Patient recruitment is expected to begin in Q4 2026.

This information is such information as Elicera Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 13:05 CET on October 12, 2026