Elicera’s CEO: “One of the biggest milestones in our history”
Elicera Therapeutics has officially entered clinical trials with its drug candidate ELC-301. This CAR T-cell therapy is being evaluated in a phase I/IIa study on patients with hard-to-treat B-cell lymphomas, mantle cell lymphoma, or indolent lymphomas where standard treatments have failed. By launching the CARMA study, Elicera takes a significant step forward, advancing cancer treatment and positioning itself as a pioneer in Swedish CAR T-cell research.
CAR T-cell therapy, one of the most promising techniques in cell therapy, has gained substantial global attention in recent years. By tailoring a patient’s own T-cells to target cancer cells, this technology has the potential to provide effective treatment options for patients with recurrent or treatment-resistant cancer. Elicera Therapeutics is the only Swedish company dedicated to CAR T therapy and aims to lead the field through its two CAR T-cell candidates, ELC-301 and ELC-401.
Launches the CARMA phase I/II study
The company recently announced the official launch of its CARMA phase I/II study by enrolling its first patient. This marks one of the most important milestones in the company’s history and a step forward in the fight against aggressive B-cell cancers. The study is structured in two phases. Initially, a dose-escalation phase involving 12 patients will be conducted to identify the optimal dose of ELC-301. Once the maximum tolerated dose is determined, an additional six patients will be treated to further evaluate safety. In total, up to 12 patients will receive treatment at the highest identified tolerable dose.
This study is being conducted at Uppsala University Hospital and Karolinska University Hospital, two leading research centers in Sweden. The first interim results from the dose-escalation phase are expected in the first half of 2025. The company anticipates completing the dose-escalation phase by the second half of 2025, with preliminary results from the second phase likely within 6–12 months thereafter, contingent on patient recruitment. Final reporting from the CARMA study is scheduled for 2028, following a minimum two-year follow-up to ensure long-term efficacy and safety.
The iTANK platform – a competitive advantage
Unlike other CAR T therapies, ELC-301 is equipped with Elicera’s patented iTANK technology, which sets it apart from the competition. The iTANK platform activates a parallel, broad immune response by engaging the patient’s own killer T-cells against a variety of tumour targets. This increases the likelihood of a more effective tumour response and helps establish a lasting immune defense that reduces the risk of relapse. For Elicera, this approach provides both a competitive edge and a potential licensing opportunity for other companies in the cell and gene therapy field. By applying iTANK to ELC-301, the CARMA study could also serve as an important validation of the iTANK technology’s potential.
CEO’s comments
BioStock reached out to CEO Jamal El-Mosleh to discuss the study’s launch and its implications.
Jamal, what does the enrollment of the first patient in the CARMA study mean for Elicera as a company and for CAR T-cell research in Sweden?
– Sweden was the first country in Europe to treat cancer patients with CAR T-cell therapy, and I am pleased that we continue to be at the forefront in Europe as Elicera begins testing an iTANK-equipped CAR T-cell therapy in cancer patients for the first time. Doing this, we hope to eventually offer even more effective treatments to more patients, including those with solid tumours.
– For Elicera, launching the CARMA study marks one of the most significant milestones in the company’s history. Starting a clinical CAR T-cell trial is an extensive and resource-intensive endeavor, but we absolutely believe the investment is worthwhile, especially from a patient perspective.
Could you tell us more about why you chose difficult-to-treat B-cell lymphomas as the target for ELC-301?
– Currently, there are already three approved CAR T-cell therapies for this indication. However, despite their relative effectiveness, around half of patients relapse and, unfortunately, can no longer be treated with standard therapies. These three approved CAR T-cell therapies for B-cell lymphomas all target the same marker, CD19, and are unarmed, unlike our candidate ELC-301, which targets CD20 and uses the iTANK platform to activate a parallel immune response against additional targets beyond CD19 and CD20.
What are the biggest challenges you might face during the dose-escalation phase, and how do you plan to address them?
– The primary purpose of the CARMA study is to assess the safety profile of the drug candidate, especially regarding the iTANK immune system activation. Since this is the first time iTANK is being tested in cancer patients, we’ll start with a relatively low dose in the first three patients. If no dose-limiting severe side effects are observed in the first treatment group, we’ll increase the dose in two additional steps until we reach the planned maximum tolerated dose. Managing challenges in the dose-escalation phase is very much about having a well-designed study with close patient monitoring.
What expectations do you have for the first interim results in the first half of 2025?
– The first interim results are expected after evaluating the initial three patients in the lowest dosing group or cohort. Our hope and expectation are, of course, to proceed to the next dosing group. Any indication of an anti-tumour effect would be a welcome bonus. However, there is a possibility that we may observe signs of anti-tumour activity even in this initial dosing group, despite the relatively low dosage and the brief follow-up period for these preliminary results.
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