On January 26, 2024, Adcoris, a leading developer of the next generation antibody drug conjugation technology, announced that it has received clearance from the China National Medical Products Administration (NMPA) for its investigational new drug (IND) application for ACR246, an injectable antibody-drug conjugate (ADC) that targets tumor associated antigen 5T4. Meantime, CDE official website also published the clinical trial approval of injection ACR246 (acceptance number: CXSL2300801) for advanced solid tumors. ACR246 is expected to start Phase 1 in human clinical trial in the first half of 2024 for solid tumors with known 5T4 expression such as esophageal, colorectal, non-small cell lung, prostate, ovarian, cervical, pancreatic, renal, breast cancers.

The drug clinical trial approval notice for injection ACR246

Clinical trial implied approval for injection ACR246

ACR246, developed independently by Adcoris, is an ADC targeting 5T4 which is highly expressed in a variety of solid tumors, with a novel TOP1 inhibitor as its payload and a stable and tumor microenvironment (TME) cleavable linker. In vivo efficacy of ACR246 significantly exceeded that of 5T4-Dxd ADC in all of the more than 10 tumor models tested. ACR246 is expected to initiate first in human clinical study in the first quarter of 2024, and is expected to become the best in its class and the world's first commercially available ADC drug against 5T4 targets.