Akeso Announced Collaboration With Chipscreen Biosciences To Initiated A Clinical Trial Of PD-1/CTLA-4 Bi-Specific Antibody In Combination With Chiauranib For PD-(L)1 Pretreated ES-SCLC

HONG KONG, March 1, 2022 /PRNewswire/ --Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide announced that it entered into a collaboration agreement with Shenzhen Chipscreen Biosciences Co., Ltd., a company listed on the Shanghai Stock Exchange (Stock code: 688321.SH) (Chipscreen Biosciences) to establish a clinical trial partnership to jointly conduct a Phase Ib/II clinical trial of PD-1/CTLA-4 bi-specific antibody Cadonilimab in combination with Chiauranib for the treatment of first-line platinum-based chemotherapy in combination with PD-(L)1 inhibitor treatment regimen for extensive stage small cell lung cancer (ES-SCLC).

This cooperation is the specific practice of the Company in the 2.0 era of tumor immunity by adhering to the innovative drug development ideas of openness, diversity and win-win, cooperating with advantageous resources in the industry, deeply exploring the value of products. Leveraging on the advantages of the Chiauranib's dual immunotherapy for oncology and the uniqueness of Chiauranib as a multi-pathway selective kinase inhibitor, the combination therapy is believed to bring more effective clinical benefits to patients in relevant studies of diseases such as lung cancer.


Cadonilimab (PD-1/CTLA-4 bi-specific antibody, AK104) is a novel, first-in-class PD-1/ CTLA-4 bi-specific immuno-oncology backbone drug independently developed by the Company. Its main indications include lung cancer, liver cancer, gastric cancer, cervical cancer, kidney cancer, esophageal squamous cell cancer, nasopharyngeal carcinoma and other malignant tumors. According to the research phase data of relevant tumors, the toxicity of Cadonilimab is significantly reduced compared with the combination therapy of PD-1 and CTLA-4, and it has obvious advantages in safety and efficacy. Based on the positive effect of Cadonilimab in the clinical trial of recurrent/metastatic cervical cancer, in August 2021, CDE has accepted the new drug application for the treatment of recurrent/metastatic cervical cancer of Cadonilimab and granted priority review qualification. As a result, Cadonilimab is expected to become the world's first PD-1-based bi-specific antibody approved for launch. In May 2021, the global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy in combination with/without Bevacizumab for the first-line treatment of continuous, recurrent or metastatic cervical cancer has also commenced.


Chiauranib is a novel chemical structure independently designed and developed by Chipscreen Biosciences with global patent protection. It is a multi-target multi-pathway selective kinase inhibitor that selectively inhibits multiple kinase targets such as Aurora B, CSF1R and VEGFR/PDGFR/c-Kit. By inhibiting mitosis in tumor cells, inhibiting tumor angiogenesis and regulating the tumor immune microenvironment, Chiauranib achieves antitumor efficacy in multi-pathway mechanisms, thereby playing a comprehensive anti-tumor effect. It has better animal efficacy and good safety profile than drugs with similar mechanisms. The clinical trial of Chiauranib for small cell lung cancer and ovarian cancer has been included as a ''breakthrough therapy type'' by the National Medical Products Administration. The Phase Ib/II clinical trial for the treatment of small-cell lung cancer by Chiauranib was in progress in the United States and has been granted orphan drug designation by the Food and Drug Administration of the United States in September 2021.


Akeso 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.


Chipscreen Biosciences, a company listed on the Shanghai Stock Exchange, (stock code: 688321.SH) is a modern biopharmaceutical company founded in 2001 by an experienced team of returnees from the United States. The Company specializes in the research and development (''R&D'') of original innovative molecular entities, and has developed a series of original innovative drug product lines in five major disease areas, including Chidamide (launched), Chiglitazar Sodium (launched), Chiauranib and CS12192, by virtue of its selfbuilt internationally advanced ''chemical genomics-based integrated drug discovery and early evaluation platform''. Chipscreen Biosciences has a global industrial layout with Shenzhen headquarters/R&D center/GMP production base, Chengdu regional headquarters/ R&D center/GMP production base, Beijing clinical research center, Shanghai commercial center and Chipscreen Biosciences (United States Limited). At the same time, as the first batch of ''Innovative Drug Incubation Bases'' in China and a national high-tech enterprise, the Company independently undertakes a number of national major scientific and technological projects and ''Major New Drug Innovation'' projects of ''863'', 10th, 11th, 12th, and 13th Five-Year-Plan. A total of 405 domestic and overseas invention patents have been applied, 113 of which have been authorized.

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SOURCE Akeso, Inc.

Company Codes: HongKong:9926

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