Chinese biopharmaceutical company Akeso Inc (HKEX:9926) announced on Saturday that the first patient has been dosed in a Phase III clinical study (COMPASSION-40/AK104-313) evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody.

Cadonilimab is being studied as monotherapy in the neoadjuvant/adjuvant (perioperative) treatment of resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer.

This marks a new indication for cadonilimab beyond gastric, lung, and cervical cancers, and represents the 13th Phase III/registrational study of the therapy conducted globally. Cadonilimab has moved from later-line to first-line treatment of advanced disease and is now being evaluated in the perioperative setting, further broadening its clinical footprint in immuno-oncology (IO) 2.0.

As the first approved checkpoint bispecific antibody for cancer, cadonilimab has shown consistent clinical benefit across a range of patients, including both PD-L1-positive and PD-L1-negative individuals, in real-world use and multiple Phase III trials.