The first patient in Elicera Therapeutics’ phase I/IIa study was disease-free already at the one-month follow-up, an effect that persisted after six months. The second patient showed possible disease progression after three months, which is now being further investigated. The third patient, who, like patient two, had previously been treated with CD19 CAR T-cell therapy, was also disease-free after one month.
The study, conducted in dose-escalating cohorts, continues with further patient recruitment to evaluate safety, tolerability, and early efficacy measures. The second cohort has already been initiated, with two of the three planned patients treated so far with a tripled dose compared to the first cohort.
Elicera intends to report preliminary results from the study as each dosing group is completed. Preliminary efficacy data from the first cohort were presented by Chief Scientific Officer and co-founder, Professor Magnus Essand, at the 7th Swedish Cancer Research Meeting in Malmö May 22th.
Comments from the CEO
We contacted CEO Jamal El-Mosleh for a comment.
Jamal, how do you interpret the complete response in patients previously treated with CD19 CAR T therapy, particularly regarding ELC-301’s immune-activating properties via iTANK?
– That a patient who failed CD19 CAR T therapy becomes disease-free with such a low dose in the CARMA study is a strong indication of the treatment’s effect and the iTANK platform’s ability to overcome resistance mechanisms such as antigen loss and T-cell exhaustion. Naturally, we cannot draw definitive conclusions from such a small sample, but our hypothesis is that iTANK’s immune-activating properties, such as enhanced T-cell function, recruitment of other immune cells, and improvement of the tumor microenvironment, enable ELC-301 to achieve responses even at low doses in a difficult-to-treat population. Patients who fail CD19 CAR T-cell therapy often have a very poor prognosis, with a median survival of just a few months, so these data strengthen our belief that iTANK can make a difference for the patients who need it most.
What do the results from patient 1 suggest about the durability of ELC-301’s potential effect?
– The results from patient 1 suggest a potentially durable effect of ELC-301, but the fact that the patient was disease-free after one month at 1/10 of the planned maximum dose is probably more surprising than the patient remaining in remission after six months. One should not expect all disease-free patients to remain in remission over the long term but based on how other patients have responded in other CAR T studies, the majority of disease-free patients seem to remain in remission after six months, and perhaps about half after five years.
What hypotheses do you have about why patient 2, previously treated with CD19 CAR T-cell therapy, shows possible progression at the three-month follow-up?
– It could be due to the previous CD19 CAR T treatment exhausting the T-cells, the lymphoma developing resistance through a suppressive tumor microenvironment, or the low dose not being sufficient to combat the disease. But it is difficult to say. I should also clarify that signs of progressive disease identified via imaging can sometimes have other causes, such as inflammation, infection, or changes that are not cancerous. Therefore, a follow-up scan after about one month is needed to confirm whether it is truly progressive disease.
How do the results from dose cohort 1, with two out of three complete responses, impact the strategy for continued dose escalation in the CARMA study?
– I would say they don’t impact it at this stage. We have started recruitment for cohort 2 and have already treated two of the three planned patients. If everything goes as planned, cohort 2 should be fully recruited before the summer, and we could potentially report preliminary data as early as Q3 in connection with participation in a suitable scientific conference. We will provide updates on this.
Jamal also participated at the BioStock Global Forum on May 20–21 in Lund – watch the presentation here.
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