NEW YORK – OneChain Immunotherapeutics (OCI) on Tuesday said it will begin a clinical trial evaluating its CD1a-targeting autologous CAR T-cell therapy in cortical T-cell acute lymphoblastic leukemia patients.
The firm has received authorization from the Spanish Agency of Medicines and Medical Products to begin the trial, dubbed CARxALL, at two Barcelona-based centers, the Hospital Sant Joan de Deu and Hospital Clinic Barcelona. The trial will enroll adult and pediatric patients from Spain and other European countries. To be eligible, patients must have the cortical T-cell subtype of ALL and lack alternative treatment options.
OCI launched two years ago as a spinout from the Josep Carreras Leukemia Research Institute, with seed funding from Invivo Ventures, CDTI-Innvierte, and the Josep Carreras Foundation in addition to the State Research Agency. The CAR T-cell therapy that OCI is now developing targets CD1a, a new target antigen that Pablo Menendez, the company's founder, developed within the Josep Carreras Leukemia Research Institute's stem cell biology, developmental leukemia, and immunotherapy group. Menendez and colleagues previously validated CD1a-targeted CAR T-cell therapy in preclinical animal studies, which demonstrated that the CAR T cells had long-term persistence in vivo.
According to Antoni Garcia Prat, the administrator of the Josep Carreras Foundation, any profits generated for the foundation through this CAR T-cell therapy will be invested in leukemia treatment and research.
In addition to the CD1a CAR T-cell therapy, OCI has treatments in its pipeline for treating other hematologic cancers as well as solid tumors. "Developing these strategies and managing all the regulatory mechanisms associated with developing a product is extremely complicated in the academic field," Menendez said in a statement. "Therefore, OCI will enable us to carry out all the necessary steps to ensure that our knowledge benefits patients."