BVX001

BVX001 is a first-in-class, bispecific antibody-drug conjugate (ADC) designed to target both CD33 and CD7 antigens, which are co-expressed on leukemic cells in approximately 30% of patients with acute myeloid leukemia (AML). Developed by BiVictriX Therapeutics, BVX001 utilizes the proprietary Bi-Cygni ADC platform and employs auristatin MMAF as its cytotoxic payload. The drug is engineered for high selectivity and potency against AML cells while sparing healthy tissues, aiming to reduce treatment-related toxicities such as bone marrow suppression and neutropenia that are common with existing therapies. Preclinical studies have demonstrated significant tumor regression in AML models and a favorable safety profile compared to current standard-of-care ADCs like gemtuzumab ozogamicin. In April 2024, BVX001 received orphan drug designation from the FDA for the treatment of AML.