Akeso, Inc. announced that it has entered into a collaboration agreement with Shenzhen Chipscreen Biosciences Ltd. to conduct a Phase Ib/II clinical study of combination therapy of Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104) and Chiauranib (a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor) in patients with ES-SCLC which progressed on combination therapy of platinum-based chemotherapy and PD-(L)1 inhibitor as first-line treatment. The drug development strategy of Akeso is to use its bispecific antibody as backbone of next generation immunotherapy to combo with innovative drugs or drug candidates from leading partners in respective fields. Akeso believes such a strategy will differentiate its therapy from peers, and further enhance the value of products, which will benefit the company and its partners.

This collaboration provides a solid proof for Akeso's commitment to promote combination therapy strategy. Combining the superior advantage of Cadonilimab as a dual immuno-checkpoint inhibitor and Chiauranib as an active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases, Akeso is confident this combination therapy will bring exciting new therapeutic solution for the patients suffering from cancers including lung cancer. Cadonilimab is a novel first-in-class PD-1/CTLA-4 bi-specific immuno-oncology backbone drug independently developed by the Company, and its major indications include lung cancer, liver cancer, stomach cancer, cervical cancer, renal cancer, esophageal squamous cell cancer, nasopharyngeal carcinoma and other malignant tumors.

The periodic research data show that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrates promising safety profile and efficacy. Based on the positive effects of Cadonilimab obtained in the clinical trial of recurrent/metastatic cervical cancer, CDE accepted the new drug application of Cadonilimab for the treatment of recurrent/metastatic cervical cancer in September 2021 and granted priority review designation. Cadonilimab is therefore expected to be the world's first-in-class PD-1 based bi-specific antibody approved for market launch.

In addition, a global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy combined with/without bevacizumab in the first-line treatment of persistent, recurrent or metastatic cervical cancer was initiated in May 2021. Chiauranib, a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor, was developed by Chipscreen Biosciences specifically to address drug resistance.Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. With a favorable safety profile, Chiauranib has outperformed drugs with a similar mechanism in its pharmacodynamic activity in animal studies.