Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B and age-related diseases, announced that it has entered into a strategic collaboration with Shanghai Junshi Biosciences Co., Ltd. to explore the synergies of Ascentage’s Inhibitor of Apoptosis Proteins (IAP) inhibitor APG-1387, and Junshi Biosciences’ anti-PD-1 therapy toripalimab in clinical trials in solid and hematological tumors in China.
APG-1387 is a novel, small molecule IAP inhibitor that induces apoptosis by mimicking the dimeric form of the SMAC protein, which is being developed to treat advanced solid tumors and chronic HBV infection. APG-1387 has completed dose-escalation Phase I trials as a single agent in solid tumors in both China and Australia. It is currently in Phase Ib trial in combination with anti-PD-1 therapy in patients with advanced solid tumors in the United States. APG-1387 is the first IAP-targeting investigational drug to enter clinical trials in China. In preclinical studies, the combination of APG-1387 and anti-PD-1 immuno-oncology therapy demonstrated strong antitumor activity, resulting in clinically relevant responses such as Complete Response (CR). These results suggest that the combination treatment may enhance the activity of PD-1 blockade therapy and warrant further investigation in humans.
Junshi Biosciences’ self-developed toripalimab is the first anti-PD-1 monoclonal antibody marketed by a Chinese company that has been approved by China’s National Medical Products Administration to be used to treat unresectable or metastatic melanoma that has failed previous systemic therapy.
“We are delighted to be partnering with Junshi on evaluating this novel combination therapy. We are proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development in China,” Dajun Yang, M.D., Ph.D., Chairman and CEO of Ascentage, said.