China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC).
AK117, a CD47 monoclonal antibody developed in-house, lacks hemagglutination effects and can bind to CD47 expressed on tumor cells, blocking the interaction between CD47 and SIRPα to enhance the phagocytic activity of phagocytes on tumor cells and inhibit tumor growth. Ivonescimab, independently developed by Akeso, is a PD-1/VEGF bispecific immunotherapy drug approved in China to treat EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. The AK117-302 study marks a significant milestone as the first global Phase III clinical trial to investigate a CD47 monoclonal antibody therapy for solid tumors.- Flcube.com
