CAR T cell therapy has transformed the treatment of relapsed or refractory B-cell malignancies such as leukemia and lymphoma, thanks to the four CD19 CAR T-cell-based therapies available in Europe. Nevertheless, 40–50% of treated patients either fail to respond or relapse after receiving approved CD19 CAR T products. This limited durability is mainly caused by antigen loss, tumour heterogeneity, immunosuppressive tumour microenvironment and functional exhaustion of the infused CAR T cells.
Elicera Therapeutics has developed iTANK, a platform designed to bring CAR T cell efficacy to another level by inducing a dual mechanism of action. iTANK arms CAR T cells with NAP, an immune-activating protein that is only released when CAR T are in close proximity to the tumour. This local release triggers broader immune activation and a bystander effect that addresses key resistance mechanisms of conventional CAR T therapy.
With support from the EIC Accelerator, Elicera has conducted a first-in-human CARMA-01 study with CAR-T cells targeting CD20 and achieved highly encouraging preliminary results from the first two treated cohorts. Among the first six patients treated in the Phase I dose-escalation stage, four achieved complete metabolic response, including one individual previously treated with commercial CD19 CAR T therapy. These responses occurred at only 10 to 30% of the intended maximum dose. No severe or unexpected adverse events were observed. Although Phase II dose confirmation study will continue beyond the project, early findings demonstrate clinical feasibility, early efficacy and safety of iTANK-armed CAR T cells in patients who had exhausted standard treatment options.
Thanks to the EIC funding, the project has validated iTANK as a safe, versatile platform technology. The clinical experience and manufacturing infrastructure developed in this project is likely to be used for Elicera’s second iTANK-based programme, ELC-401 dedicated to incurable brain cancer - glioblastoma, provided sufficient funding is secured. Established in this project, a national clinical network and developed GMP and regulatory frameworks position Elicera as an European leader in advanced next-generation CAR T innovations.
