Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.
Preclinical Efficacy and Safety Profile of AK132
Preclinical studies have demonstrated AK132’s high-affinity binding to human Claudin18.2 and CD47, effectively blocking the interaction between human CD47 and its ligand human SIRPα. The molecule has shown the ability to mediate the phagocytosis of cells co-expressing CLDN18.2 and CD47 by macrophages, thereby inhibiting tumor development in a mouse subcutaneous transplant tumor model. Additionally, AK132 has exhibited no antibody-dependent cellular cytotoxicity (ADCC) or antibody-dependent cellular phagocytosis (ADCP) activity in the human RBC target cell system and has not caused RBC agglutination, indicating a favorable safety profile.
Implications for Akeso Biopharma and Oncology Treatment
The approval of AK132 for clinical studies represents a significant step forward for Akeso Biopharma, as it continues to expand its pipeline of innovative oncology treatments. The molecule’s unique mechanism of action and preclinical data suggest potential for effective treatment of advanced solid tumors, offering new hope for patients in need of novel therapeutic options.-Fineline Info & Tech
