Until now, five different CART cell products have been approved by the U.S.A. Food and Drug Administration. Four of these products target CD19, and are used to treat acute lymphoblastic leukemia, B-cell lymphoma, follicular lymphoma or mantle cell lymphoma. The fifth product targets BCMA and has been approved to treat multiple myeloma.
The scientific team involved in Gyala is behind the development of two CART products.
ARI-0001 targets CD19 and has been approved by the Spanish regulatory authory AEMPS (Agencia Española del Medicamento y Productos Sanitarios) for use in hospital context to treat patients older than 25 years old with acute lymphoblastic leukemia who have relapsed conventional therapy.
ARI-0002 targets BCMA and is currently being tested in patients with relapsed/refractory multiple myeloma.
Gyala’s founders have identified a novel CAR T target that is overexpressed in overexpressed in several hematological malignancies for which CART therapies have not yet been approved, such as of chronic lymphocytic leukaemia (CLL), Burkitt’s lymphoma, diffuse large B-cell lymphoma (DLBC), acute myeloid leukaemia (AML) or T-cell acute lymphoblastic leukaemia (T-ALL).