Genrix Bio has received a priority review designation from its homeland China's Centre for Drug Evaluation (CDE) for its bispecific antibody (BsAb) velinotamig, for the treatment of adults with relapsed or refractory multiple myeloma (r/r MM) who have received at least three prior lines of therapy. Velinotamig is a BCMA×CD3 BsAb designed with asymmetric affinity — its binding affinity for BCMA is two orders of magnitude higher than for CD3. This design aims to effectively recruit and activate T-cells against tumour cells while minimising off-target T-cell activation and associated toxicity.

Clinical data showed promising efficacy. In a Phase I study, the objective response rate (ORR) was 89.5% among 57 efficacy-evaluable patients. For the 48 patients treated at the recommended Phase II dose of 180 µg/kg, the ORR was 87.5%, with 70.8% achieving at least a very good partial response and 37.5% achieving at least a complete response. Furthermore, 54.2% of patients in this cohort achieved minimal residual disease (MRD) negativity.

According to PharmCube's NextBiopharm® database, velinotamig is also being developed in lupus and another unspecified autoimmune disease. Click here to request a free trial for NextBiopharm®.