Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in Combination with VEGFR-2 Monoclonal Antibody Obtained Approval to Initiate Phase Ib/II Clinical Trial for Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Cancer

(HONG KONG, July 5, 2021) Akeso, Inc. (9926.HK) is pleased to announce that the Company has received the approval from the National Medical Products Administration (the NMPA) of the People’s Republic of China to initiate an open-label, multicentre phase Ib/II clinical trial for the global first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bispecific antibody, research and development code: AK104), an immunooncology therapy jointly developed by the Company, and VEGFR-2 monoclonal antibody (research and development code: AK109), jointly developed by the Company and Dawnrays Pharmaceutical (Holdings) Ltd., in combination with/without chemotherapy for second-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer.


Although the current PD-1 monoclonal antibody for first-line treatment of advanced gastric cancer has achieved positive results, the survival benefit of second-line treatment of advanced gastric cancer remains limited. In the future, a considerable part of the second-line population of gastric cancer may be post PD-1 monoclonal antibody immunotherapy patients. This clinical trial in combination with VEGFR-2 focuses on patients with advanced gastric cancer who have experienced failure of PD-(L)1 treatment, and is expected to become a new hope for the second-line treatment of advanced gastric cancer. This is the Companys another combination drug research rapidly launched for urgent clinical needs by fully utilizing the advantage of its diverse self-developed product pipeline. The Company has already started the phase III clinical study of Cadonilimab in combination with chemotherapy for first-line treatment of gastric cancer in China.

Gastric cancer is one of the common cancers in the world. In 2020, there were more than
one million new cases of gastric cancer worldwide with 769,000 cases of death, making it the fifth common cancer and the fourth leading cause of death in relation to cancer in the world. The incidence rate and mortality rate of gastric cancer in China is just second to lung cancer.


Information about Cadonilimab (PD-1/CTLA-4 Bispecific 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. Our AK104 project has been incorporated in the Major New Drug Innovation Program under the 13th Five-year Plan for Major Technology Project (十三五「重大新藥創製」科技重大專項支持專案) issued by the National Health Commission and Ministry of Science and Technology in 2017 and has been enlisted in the 2017 Pearl River Talent Program of Guangdong Province — Introduction of Innovation and Entrepreneurship Team Support Program (2017年廣東省「珠江人才計劃」 引進創新創業團隊支持專案). It was also jointly rated by the China Medical Biotechnology Association and Chinese Medicinal Biotechnology as one of the 2017 Top Ten Medicinal Biotechnology Advancements in China (2017年中國醫藥生物技術十大進展).


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) Ltd., 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 the Company

The Company 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 – 2 – 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.