Akeso Announces Clinical Collaboration with Pfizer to Evaluate Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in Combination with Axitinib for First-Line Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma

【HONG KONG, August 27, 2021】Akeso (9926.HK) announced that the Company has entered into a collaboration agreement with Pfizer Inc. to establish a clinical research partnership and conduct a clinical study evaluating cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination with Pfizer’s axitinib (brand name: INLYTA®) for the treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC). This trial aims to evaluate the efficacy and safety of the combination of cadonilimab and axitinib as a first-line treatment for advanced/metastatic clear cell renal cell carcinoma (ccRCC).

Cadonilimab is a globally first-in-class, novel, potentially next-generation bispecific antibody developed by Akeso as a backbone therapy for tumor immunotherapy, simultaneously targeting the PD-1 and CTLA-4 immune checkpoint molecules. Interim data from ongoing clinical studies across multiple indications demonstrate that, compared to PD-1 monoclonal antibody monotherapy or the combination therapy of PD-1 and CTLA-4 monoclonal antibodies, Cadonilimab exhibits significant advantages in both efficacy and safety.

Axitinib (Inlyta®) is an oral, potent, and highly selective tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 that inhibits tumor growth, angiogenesis, and tumor progression, and is indicated for adult patients with advanced renal cell carcinoma (RCC) following failure of prior treatment with one tyrosine kinase inhibitor or cytokine therapy.

Leveraging the advantages of the Cadonilimab bispecific antibody in cancer immunotherapy and the unique efficacy of axitinib in renal cancer, this combination therapy is expected to provide patients with more effective treatment options in relevant studies on kidney cancer and other related diseases.

About Cadonilimab (PD-1/CTLA-4 Bispecific Antibody)

Cadonilimab (AK104) is a novel, potential first-in-class PD-1/CTLA-4 bispecific tumor immunotherapy drug independently developed by Akeso. Its primary indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, and renal cell carcinoma, among others. Preliminary interim data from clinical studies in cervical cancer, gastric cancer, and other tumors indicate that, compared with PD-1 plus CTLA-4 combination therapy, Cadonilimab exhibits significantly reduced toxicity and demonstrates clear advantages in safety and efficacy. AK104 was supported by the 2017 "Major New Drug Creation" Science and Technology Major Project under the 13th Five-Year Plan, sponsored by the National Health Commission and the Ministry of Science and Technology, as well as by the 2017 Guangdong Province "Pearl River Talent Plan" for introducing innovative and entrepreneurial teams. It was jointly recognized by the Chinese Association of Medical Biotechnology and the *Chinese Journal of Medical Biotechnology* as one of the "Top Ten Advances in Chinese Medical Biotechnology in 2017."

About Inlyta® (Axitinib)

INLYTA® is an oral, potent and highly selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 that inhibits tumor growth, angiogenesis, and tumor progression. It is indicated for adult patients with advanced renal cell carcinoma (RCC) following failure of prior treatment with one tyrosine kinase inhibitor or cytokine therapy.

Inlyta® (axitinib) was the first targeted drug approved in the United States for patients with advanced renal cell carcinoma who have failed prior therapy.

Inlyta® initially received marketing approval from the U.S. FDA in January 2012 and was subsequently approved by the NMPA in April 2015. To date, it has been approved in 81 countries/regions, including the European Union, Japan, and South Korea.

Managing Editor: Liuli

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