PD-1/CTLA-4 Bi-specific Antibody in Combination with VEGFR-2 Monoclonal Antibody Obtained Approval to Initiate Phase Ib/II Clinical Trial for Treatment of Advanced Solid Tumors

[HONG KONG, 4 Aug 2021] Akeso, Inc. (9926.HK, the “Company”) announced that the Company has received the approval from the National Medical Products Administration of China to initiate an open-label, multicenter phase Ib/II clinical trial for the global first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, AK104), an immuno-oncology therapy independently developed by the Company, in combination with VEGFR-2 monoclonal antibody (AK109), jointly developed by the Company and Dawnrays Pharmaceutical (Holdings) Limited, for treatment of advanced solid tumors.


In recent years, immunotherapies represented by PD-1 has improved patient prognosis in a variety of advanced solid tumors. However, the survival benefits of immunotherapies to patients with advanced solid tumors are still limited. Research shows that there is interplay between immune cells and tumor angiogenesis, providing the theoretical rationale for anti-angiogenesis drug in combination with immune checkpoint inhibitor for treatment of malignant tumors.


Cadonilimab is a bi-specific antibody targeting PD-1 and CTLA-4, which unblocks immunosuppression at different cycles of the acquired immune pathway, mobilizing and activating T cells to kill tumor cells. AK109 binds to human VEGFR-2 protein with high affinity, inhibiting the proliferation of vascular endothelial cells induced by VEGF/VEGFR-2 binding.


By combining antiangiogenic drug and immune checkpoint inhibitors, the clinical trial of PD-1/CTLA-4 bi-specific antibody in combination with VEGFR-2 monoclonal antibody focuses on patients with advanced solid tumors who have failed in standard treatments and some patients receiving initial treatment, expecting to bring new hope to patients with advanced solid tumors.


Akeso, Inc. has previously initiated a phase I clinical trial of AK109 for treatment of advanced solid tumors and phase Ib/II clinical trial of AK109 in combination with Cadonilimab for treatment of gastric cancer in China.



Information about Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody, AK104)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/ CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.



Information about AK109 (VEGFR-2 Monoclonal Antibody)

AK109 is a new all-human VEGFR-2 monoclonal antibody drug jointly developed by the Company and Dawnrays Pharmaceutical (Holdings) Limited, which can be used for the treatment of various malignant tumors. AK109 does not activate ADCC and can bind specifically to human VEGFR-2 protein with high affinity, which blocks VEGF binding to VEGFR-2 and effectively inhibits the proliferation of vascular endothelial cells induced by VEGF/VEGFR-2 binding, thus interfering with tumor angiogenesis and inhibiting the occurrence and development of tumors. The Company will actively explore the relevant studies on the combination therapies of AK109 with other drugs from the Company’s product pipeline in the near future.



Information about Akeso, Inc.

Akeso, Inc. (stock code: 9926.HK) is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.


Information about Dawnrays Pharma

Dawnrays Pharma is a Chinese company engaged in the development, manufacturing and the sale of medicines, a subsidiary of Dawnrays Pharmaceutical (Holdings) Limited. (stock code: 02348). Dawnrays Pharma’s cephalosporin antibiotic products include  intermediates and bulk medicines, powder for injection, and oral preparations. Its specific

medicines cover the cardiovascular system, anti-HBV, anti-allergic, digestive system, urinary system and endocrine system. The dosage forms include tablets, capsules, granules, dripping pills, and dry suspensions. Dawnrays Pharma has developed its anti-infective agents series named "Xian" series, together with its cardiovascular drug product brands named "An" series. The market share of these product series are relatively high.