China-based Akeso Biopharma (HKG: 9926) has announced the first patient enrollment in a Phase Ia/Ib clinical study for its TIGIT monoclonal antibody (mAb) AK127, combined with cadonilimab (AK104), a novel bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), for the treatment of advanced malignant solid tumors. This combination therapy has previously concluded a dosage escalation study in Australia.
Cadonilimab’s Approval and Ongoing Studies
Cadonilimab received conditional approval in China in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who had previously failed platinum-based chemotherapy. As a global first-in-class PD-1/CTLA-4 BsAb, cadonilimab is under ongoing study for various indications, including gastric cancer/gastroesophageal junction cancer (GC/GEJ), hepatocellular carcinoma, and others. Patient enrollments have been finalized for a pivotal regulatory Phase III study combining cadonilimab with chemotherapy with/out bevacizumab for first-line recurrent or metastatic cervical cancer, as well as another pivotal regulatory Phase III study for the drug combined with chemotherapy in first-line gastric cancer.
AK127: An Innovative Approach to Immune Checkpoint Inhibition
AK127 is an in-house developed human IgG1k mAb that targets TIGIT, an immune checkpoint inhibitory receptor and a member of the growing poliomyelitis virus receptor (PVR)-like protein family. AK127 specifically binds to TIGIT, blocking the interaction between TIGIT and its ligands, which aims to relieve immunosuppression and promote an anti-tumor immune response. This innovative approach has the potential to enhance the efficacy of immunotherapies in cancer treatment.-Fineline Info & Tech
