Green light to continue Elicera’s CARMA-trial in B-cell lymphoma
Elicera Therapeutics has received the green light from the Data Safety and Monitoring Board (DSMB) to continue its phase I/IIa clinical trial, CARMA, evaluating the CAR T-cell therapy candidate ELC-301 for B-cell lymphoma. Armed with immune-activating properties via the company’s iTANK platform, the therapy is a key component of Elicera’s broader immunotherapy strategy. The approval comes as the company prepares to present preliminary efficacy data from the first patient cohort in May.
The CARMA trial, conducted in collaboration with Uppsala University, is designed to assess the safety and efficacy of ELC-301. In the trial’s first part – a dose-escalation phase involving 12 patients – a complete response was observed in the first patient treated with 1/10 of the planned max dose at the one-month follow-up, with no serious adverse events reported. Since then, two additional patients have been treated at the same low dose in cohort 1.
Following the DSMB’s evaluation, the study is now cleared to proceed to the next dosing level. Elicera intends to report results after each completed cohort, with the first preliminary efficacy data set to be presented at the 7th Swedish Cancer Research Meeting in Malmö on May 22.
– The positive recommendation to continue the trial with the next dose level is an important validation of our approach. We are now accelerating patient recruitment and moving to the next dosing level with the goal of demonstrating ELC-301’s full clinical potential, Elicera’s CEO Jamal El-Mosleh says in a comment to BioStock.
iTANK platform enhances ELC-301’s potential
At the heart of Elicera’s therapeutic innovation is the iTANK platform, a proprietary technology that augments CAR T-cell therapies by enabling parallel immune activation. In ELC-301 and across its pipeline, this dual-action mechanism is designed to extend the treatment’s effectiveness, enhancing the ability to target and destroy cancer cells. Elicera believes this dual mechanism of action could be especially effective in combating hard-to-treat solid tumours, where conventional CAR T-cell therapies often fall short.
ELC-301 is one of three drug candidates in Elicera’s pipeline using the iTANK platform, alongside ELC-401 and ELC-201. While ELC-301 targets B-cell lymphoma, the latter two are in preclinical development for solid tumours. Encouraged by preclinical efficacy data, Elicera is also advancing commercial opportunities by offering iTANK to external CAR T-cell developers under non-exclusive licenses.
– With iTANK, we are not just developing new treatments, we are enhancing what CAR T-cells can achieve. Our ambition is to establish iTANK as a standard complement in next-generation immunotherapy, El-Mosleh says.
Clinical and strategic milestones ahead
2025 is shaping up to be a milestone-rich year for Elicera. In addition to readouts from cohorts 1 and 2 in the CARMA trial, the company plans to complete the dose-escalation phase of its oncolytic virus candidate ELC-100. Parallel efforts are underway to secure funding and partnerships for advancing ELC-201 and ELC-401 into the clinic.
The company is also actively pursuing licensing agreements for the iTANK platform, which has the potential to generate non-dilutive revenue. While Elicera remains optimistic about these developments, El-Mosleh has noted that securing new partnerships or funding cannot be guaranteed within the year. Nevertheless, the company remains focused on these key growth opportunities.
The financial runway extends into 2027
Elicera’s ability to move forward confidently is supported by the successful exercise of its TO2 warrants in March 2025. The warrants were subscribed to approximately 96.3 per cent, generating SEK 21.2 million before issue costs. The round was fully covered through subscriptions and underwriting, ensuring funding is in place for clinical milestones and operations to at least the second half of 2027.
The company has confirmed that no new clinical studies are planned within the scope of this capital raise. Instead, the focus remains on advancing the CARMA trial and sustaining research momentum across its pipeline without requiring further dilution.
– With a solid financial runway and strong early data, we are now well-positioned to accelerate our development efforts in 2025 and beyond. The CARMA trial is a critical part of that journey and an opportunity to showcase the power of our iTANK platform in action, Jamal El-Mosleh concludes.
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