Casi announces partnership with Juventas Cell Therapy

CASI Pharmaceuticals announce its partnership with Juventas Cell Therapy. The China National Medical Products Administration, or NMPA, has granted market approval for Juventas’ investigational cell therapy, Inaticabtagene Autoleucel, for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in China. Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product comprised of a unique CD19 scFv, or HI19a,structure and utilizes leading CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of efficacy, with durable remissions, and substantially improved safety profile with reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL. This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China. The 9.3-month follow up data demonstrated very high durable response, overall response rate, or ORR: 82.1%, complete response rate, or CR: 66.7% within 3 month after infusion and median duration of response, or DoR, has not reached. The safety profile shown the decreased severity of CAR T-Cell related adverse events in patients with r/r B-ALL. Given the currently available treatment options in China, Inaticabtagene Autoleucel will be the first treatment CAR-T therapy option with a positive benefit-risk ratio for adult patients with r/r B-ALL and potentially be a best-in-class CAR-T product.