Elicera CEO: “These early results are very encouraging”

“Seeing 4 out of 6 patients deemed free of active disease by the principal investigator, even at these low doses, is very encouraging. It speaks to the unique ability of iTANK to activate a broader immune response and bodes well for even stronger results as we move into the highest dose cohort,” says CEO Jamal El-Mosleh.

The CARMA study evaluates ELC-301, Eliceras next-generation CAR T-cell therapy armed with the company's immune-boosting iTANK platform, in patients with relapsed or refractory B-cell lymphoma. These patients have few treatment options, and many have previously failed to respond to existing CAR T therapies.

The study is divided into two parts: a Phase I dose escalation phase with 12 patients, followed by a smaller Phase IIa expansion cohort with six patients. The primary aim of Phase I is to evaluate safety, while efficacy is measured in parallel.

Promising early data

Preliminary data, presented at the Karolinska ATMP Center's inauguration in Stockholm yesterday, show promising signs of ELC-301's potential:

– Cohort 1 (lowest dose, 3 patients): Two achieved complete metabolic response (CMR, no active disease) at one month follow-up. One remained disease-free at nine months, while the other noted progressive disease at three months. The third patient initially had stable disease that later progressed.

– Cohort 2 (three times higher dose, 3 patients): Two achieved CMR after one month, and one confirmed disease-free after three months. The third showed a partial response that was maintained after three months.

Overall, 4 out of 6 patients treated to date achieved complete remission, demonstrating ELC-301's potential for difficult-to-treat cases.

Safety milestone achieved

And that's not the only good news – the DSMB (Data Safety and Monitoring Board) has also given the go-ahead for the study to continue as planned.

The DSMB has completed its second safety review and confirmed that the study can proceed to the third and final Phase I cohort, where patients will receive the maximum planned dose – ten times higher than in the first cohort. This milestone highlights ELC-301’s favorable safety profile and paves the way for broader testing.

Looking ahead

The final Phase I cohort will evaluate the efficacy of ELC-301 at the highest dose. If safety is confirmed, the Phase IIa expansion study will focus on validating the treatment’s efficacy in an additional six patients who will receive the highest dose. For patients with relapsed or refractory B-cell lymphoma, who often face a challenging prognosis, these results provide renewed hope.

CEO comment

We contacted Elicera Therapeutics CEO, Jamal El-Mosleh, for a comment on the promising results from the CARMA study and the DSMB's recommendation to proceed with the final dose cohort.

What do you think is the most important thing to take away from the preliminary data? 

– The most important takeaway from the preliminary results from the CARMA study is the strong safety profile and promising efficacy of our iTANK-armed CAR T-cell therapy, ELC-301, in a very challenging patient population. In the dose escalation phase of this Phase I/IIa study, our primary focus is to carefully evaluate the safety of ELC-301, as this is the first time our proprietary iTANK platform has been tested in patients. The Data Safety and Monitoring Board (DSMB) has approved the first two low-dose cohorts – no serious or unexpected adverse events were observed, which is an important milestone. This has given us approval to proceed to the third and final cohort, where patients will receive the highest planned dose, ten times that of cohort 1. What makes these results particularly compelling is the patient population we are treating. These are individuals with recurrent or refractory B-cell lymphoma who have already undergone at least two prior lines of standard therapy and failed, with the majority in our first two cohorts having received three or more lines – some significantly more.

“This makes them a particularly difficult-to-treat population. Notably, one patient who achieved a complete metabolic response (CMR) had previously failed standard treatment with CD19-targeted CAR T-cell therapy, underscoring the potential of our iTANK platform to overcome resistance mechanisms. Seeing 4 out of 6 patients deemed free of active disease by the principal investigator, even at these low doses, is very encouraging. It speaks to the unique ability of iTANK to activate a broader immune response and bodes well for even stronger results as we move into the highest dose cohort. These early results reinforce our belief that ELC-301 can offer a transformative treatment for patients with limited options.”

What level of reliability do these results give you during the course of the study?

– The early results from the first two groups in our CARMA study give us strong confidence in the safety of the doses we have tested. As this Phase I/IIa study is primarily about establishing the safety of our iTANK-armed ELC-301 treatment – ​​the first time it has been used in patients – the fact that we have not seen any serious side effects so far is a major win. The study’s safety committee has approved a move to the highest dose group, but we are cautious about possible side effects at this level as it is not yet tested. On the treatment side, we are pleased that 4 out of 6 patients showed no signs of active disease, especially since most had already tried and failed three or more treatments. This is a tough group to treat, so these results are very promising. However, with only a few patients tested so far, we need to be cautious. As we now move to the final dose group, we hope for even better insights into how ELC-301 can help patients with difficult-to-treat B-cell lymphoma.

What role does the iTANK platform play in ELC-301's ability to achieve responses in patients who have failed previous CAR T therapies?

– The iTANK platform is designed to boost the immune system's attack on cancer cells, and we believe it plays a key role in ELC-301's promising results in the CARMA study, especially for the patient who had failed previous CAR T treatments. The patient had previously been treated with CD19-targeted CAR T cells, which target a specific protein on cancer cells. ELC-301, on the other hand, targets a different protein, CD20, which could explain why the patient who did not respond to CD19 treatment achieved a complete metabolic response with our treatment. However, patients who have already failed CAR T-cell therapy are generally much more difficult to treat for various reasons, such as weakened immune systems or more resistant cancer. The fact that 4 out of 6 patients in our low-dose groups did not show any active disease is very encouraging. While we cannot yet confirm that iTANK is the sole reason for this success, we are optimistic that its ability to trigger a broader immune response is making a significant difference, and we hope to learn more as we test higher doses.

What challenges lie ahead as the study moves to the highest dose cohort?

“As we move into the highest dose cohort of the CARMA trial, the challenges are similar to those we faced in the first two cohorts, with the key difference being the significantly increased dose – ten times that of the lowest dose group. This escalation naturally raises important safety considerations as we must closely monitor any adverse events that may occur with this higher dose of our iTANK-armed ELC-301 treatment. However, this higher dose also carries the potential for even stronger efficacy, building on the encouraging results we have seen in the low dose groups. We are optimistic about patient recruitment for this final cohort as our recruitment process has been rapid and efficient to date, allowing us to maintain momentum in evaluating ELC-301’s potential for the treatment of relapsed or refractory B-cell lymphoma.”