Chinese biopharmaceutical company Akeso Biopharma (HK:9926) announced on Wednesday that the first patient has been enrolled in its randomised, controlled, multicentre Phase III clinical study for head and neck squamous cell carcinoma.

This study will assess the PD-1/VEGF bispecific antibody ivonescimab along with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS greater than or equal to 1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC).

According to Akeso, this is the first Phase III clinical trial worldwide to assess a CD47 monoclonal antibody therapy for solid tumours. It is the fifth Phase III study for ivonescimab, using PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab.

AK117 has been independently developed by Akeso and is a next-generation humanised lgG4 anti-CD47 antibody without hemagglutination impact. Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso.