Akeso Announced Enrollment of First Patient in Phase 3 Trial of Cadonilimab for Consolidation Therapy After Concurrent or Sequential Chemoradiotherapy in NSCLC

HONG KONG, Feb. 13, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") announced the recent completion of the first patient enrollment in the Phase 3 randomized, double-blind, multicenter clinical trial (COMPASSION-30/AK104-309) for its independently developed PD-1/CTLA-4 bispecific antibody, cadonilimab. This study is evaluating the efficacy of cadonilimab compared to sugemalimab (PD-L1) as a consolidation therapy for patients with locally advanced, non-resectable, non-small cell lung cancer (NSCLC) who have not experienced disease progression following concurrent or sequential chemoradiotherapy.

The COMPASSION-30/AK104-309 study is led by Prof. Jinming Yu, Academician of the Chinese Academy of Engineering and Director of the Oncology Hospital at Shandong First Medical University.

Currently, consolidation therapy with immune checkpoint inhibitors following concurrent or sequential chemoradiotherapy is the standard of care for patients with unresectable NSCLC. The use of immune checkpoint inhibitors as consolidation therapy has demonstrated a modest improvement in overall survival for patients. However, despite these advancements, there continues to be a significant unmet clinical need within this patient population, underscoring the urgent demand for more effective treatment options.

As a global first-in-class bispecific antibody targeting both PD-1 and CTLA-4, cadonilimab is anticipated to enhance the efficacy of immunotherapy compared to PD-1/PD-L1 single-target antibodies. Cadonilimab exerts its effects through multiple mechanisms that contribute to the "normalization" of the tumor microenvironment. Its unique tetravalent symmetric structure, combined with Fc modifications, facilitates targeted accumulation in tumor tissues. These distinctive features enable cadonilimab to potentially improve the effectiveness of cancer immunotherapy while minimizing the risk of adverse effects.

About Cadonilimab
Cadonilimab is a novel global first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug independently developed by Akeso. In June 2022, cadonilimab was granted marketing approval by the NMPA for the treatment of recurrent/metastatic cervical cancer patients who have progressed on or after platinum-based chemotherapy, and became the world's first approved PD-1/CTLA-4 bi-specific antibody. In September 2024, cadonilimab as a first-line treatment of unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma was approved in China. Currently, the Company is conducting more than 23 clinical trials of cadonilimab combination therapies covering 16 indications including but not limited to cervical cancer, gastric cancer, liver cancer and lung cancer.

About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

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