Akeso, Inc. announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study on the treatment of patients with advanced solid tumors using self-developed Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104),  a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by Akeso, and VEGFR-2 monoclonal antibody (AK109) developed by AD Pharmaceuticals.

In recent years, immunotherapy represented by PD-1 has improved the prognosis of patients with a variety of advanced solid tumors, but the survival benefit of immunotherapy for patients is still limited. This study has found an interaction between immune cells and tumor angiogenesis, providing a theoretical basis for the combination of anti-angiogenic drugs and immune checkpoint inhibitors to treat malignant tumors.

Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4 that relieves immunosuppression and mobilizes and activates T cells to kill tumor cells at different cycles of the acquired immune pathway. AK109 can bind to human VEGFR2 protein with high affinity, thereby effectively inhibiting the proliferation of vascular endothelial cells induced by VEGF/VEGFR2 binding.

In this clinical study of PD-1/CTLA-4 bispecific antibody combined with VEGFR-2 monoclonal antibody, the combination of anti-angiogenic drugs and immune checkpoint inhibitors is expected to benefit patients with advanced solid tumors, especially those for whom standard treatment has failed and some treatment-naïve patients.

AD Pharmaceuticals previously initiated the Phase I clinical study of the VEGFR-2 monoclonal antibody (AK109) in the treatment of advanced solid tumors in China, as well as the Phase Ib/II clinical study of AK109 combined with Cadonilimab in the treatment of gastric cancer.