Akeso and CStone Secure China Clearances for Next-Generation Antibody-Drug Conjugates
Hong Kong-based biopharma company Akeso has received clinical trial clearance in China for its next-generation antibody-drug conjugate (ADC), AK157D1, which targets B7-H3. This clearance paves the way for a Phase I study in patients with advanced solid tumors. AK157D1 is the third of Akeso’s next-generation ADC candidates to enter clinical development, following TROP2/Nectin-4-targeting AK146D1 and HER3-directed AK138D1. Akeso plans to test AK157D1 in combination with its bispecific antibodies, ivonescimab and cadonilimab, as part of its 'IO2.0 + ADC2.0' strategy. B7-H3 is an immune checkpoint protein found in various solid tumors, including non-small cell lung cancer, prostate, colorectal, and breast cancers, making it a prime target for antibody-based therapies. AK157D1 uses a humanized IgG1 antibody linked to Dxd, a topoisomerase I inhibitor, to deliver the treatment directly to cancer cells. Preclinical testing showed anti-tumor activity and a favorable safety profile, potentially addressing toxicity i...