(HONG KONG, 27 Aug. 2021) Akeso, Inc. (9926.HK, the “Company”) announces that the Company has reached an agreement with Pfizer Inc.(“Pfizer”), to establish a partnership of clinical research. A phase II clinical study of Akeso’s Cadonilimab, with the combination of Pfizer’s Axitinib (product name: INLYTA®) for the treatment of advanced / metastatic clear cell renal cell carcinoma (ccRCC) is launched. This clinical study is to evaluate the efficacy and safety of Cadonilimab in combination with Axitinib as a first-line treatment for advanced/metastatic clear cell renal cell carcinoma (ccRCC).
Bi-specific antibody drug Cadonilimab, developed by Akeso Biopharma, is a novel, potential next-generation, immuno-oncology backbone drug. Cadonilimab simultaneously targets two validated immune checkpoint molecules: PD-1 and CTLA-4. The ongoing research data shows that, as compared with the PD-1 monoclonal antibody or the combination therapy of PD-1 monoclonal antibody and CTLA-4 monoclonal antibody, Cadonilimab has greater efficacy and better safety advantages.
Axitinib (INLYTA®), developed by Pfizer, is an oral, potent, highly selective tyrosine kinase receptor inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors). INLYTA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with a tyrosine kinase inhibitor (TKI) or a cytokine.
Riding on Cadonilimab’s advantage as a next-generation, bi-specific, immuno-oncology antibody drug, together with the unique efficacy of Axitinib in the treatment of renal cancer, the Company believes this combination therapy is expected to provide better treatment options for the patients in relevant researches of renal cancer or other indications.
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 INLYTA® （Axitinib）
INLYTA® is an oral, potent, highly selective tyrosine kinase receptor inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors). INLYTA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with a tyrosine kinase inhibitor (TKI) or a cytokine.
INLYTA® is the 1st target therapy approved for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy in the U.S.
INLYTA®, initially approved by FDA (U.S) in January 2012, was approved by NMPA (China) in April 2015. Now it has been approved in 81 countries/regions including EU, Japan and Korea.
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, Akeso’s first self-developed new anti-PD-1 antibody Penpulimab (安尼可®) officially obtained marketing approval. The Company’s vision is to become a global leading biopharmaceutical company through research and development (‘‘R&D’’) of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.
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