(HONG KONG, 18 Oct 2021) Akeso, Inc. (the Company, 9926.HK) announces that the Company will publish three clinical trials results on PD-1/CTLA-4 bi-specific antibody Cadonilimab monoclonal antibody (AK104) for treating nasopharyngeal carcinoma and PD-1/ VEGF bi-specific antibody AK112 for treating ovarian cancer, as well as three mechanism studies results on Cadonilimab, CD47 monoclonal antibody AK117 and CD73 monoclonal antibody AK119 at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (‘‘SITC 2021’’) on Nov 10-14, 2021.
Three clinical trials are as follows:
No. Research title
1 A phase II study of AK104, a bi-specific antibody targeting PD-1 and CTLA-4, in patients with metastatic nasopharyngeal carcinoma (NPC) who
had progressed after two or more lines of chemotherapy
2 Efficacy and safety of AK112, an anti-PD-1/VEGF bi-specific antibody, in patients with platinum-resistant epithelial ovarian cancer in a phase I study
3 A phase Ib/II clinical study of AK112, a PD-1/VEGF bi-specific antibody, in combination with olaparib in BRCA germline wild-type platinum sensitive
recurrent ovarian cancer
Three mechanism studies are as follows:
No. Research title
1 Cadonilimab, an anti-PD-1/CTLA-4 bi-specific antibody with Fc effector null backbone
2 AK117, a CD47 blocking antibody with robust macrophage activation without red blood cell hemagglutination
3 AK119, a CD73 targeting antibody with dual mechanism of action
About Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody)
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.
About AK112 (PD-1/VEGF Bi-Specific Antibody)
AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique Tetrabody technology, AK112 blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor microenvironment, AK112, as a single agent to block these two targets, may block these two pathways more effectively and enhance the anti-tumor activity, as compared to combination therapy.
About AK117 (CD47 Monoclonal Antibody)
AK117 is a novel humanized IgG4 mAb independently developed by the Company. It can bind with CD47 expressed on tumor cells to prevent the interaction between CD47 and its receptor, SIRPα, expressed on macrophages so as to enhance phagocytosis to inhibit the growth of tumor cells. Previously published data demonstrated exceptional safety profile. AK117 resulted in no dose-limiting toxicity and no anemia of clinical significance in subjects in all dose escalation cohort (the highest dose cohort was 45 mg/kg once-weekly), and was well tolerated by subjects in all cohorts. The CD47 receptor occupancy rate (RO) of the peripheral blood T cells has reached and maintained at 100% in the 3 mg/kg cohort.
About AK119 (CD73 Monoclonal Antibody)
As a full antagonist of CD73 activity, AK119 completely blocks CD73 activity, causes B cell activation and enhances antibody production. Enhanced antibody production in Novel Coronavirus (‘‘COVID-19’’) patients may potentially augment their ability to destroy SARS- CoV-2 virus. Therefore, AK119 could potentially be the effective treatment to be used for COVID-19 illness. AK119 may also result in stronger immunity to SARS-CoV-2 virus, and potentially be used in conjunction with vaccination of healthy people to enhance the efficacy of vaccines.
About Akeso, Inc.
Akeso, Inc. 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). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. 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.
