Akeso Achieves Milestone with First Patient Enrollment in Phase III Trial of Ivonescimab for Advanced Metastatic Colorectal Cancer
Shanghai, China – July 16, 2025 – Akeso, a leading biopharmaceutical company, is pleased to announce a significant advancement in its clinical development program with the enrollment of the first patient in its Phase III clinical trial of ivonescimab for the first-line treatment of advanced metastatic colorectal cancer (CRC). This pivotal trial, designated as AK112-312/HARMONi-GI6, represents a crucial step forward in the company’s commitment to addressing unmet medical needs in oncology.
Ivonescimab (AK112) is a novel bispecific antibody designed to simultaneously inhibit both VEGF and Ang-2, two key pathways involved in tumor angiogenesis and immune suppression. By targeting these critical mechanisms, Akeso aims to offer a new therapeutic option that may improve outcomes for patients with advanced metastatic CRC, a challenging disease with significant global health implications.
The HARMONi-GI6 trial is a global, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of ivonescimab in combination with standard chemotherapy, compared to placebo in combination with standard chemotherapy, as a first-line treatment for patients with advanced metastatic colorectal cancer. The trial is designed to enroll a substantial number of participants across numerous clinical sites worldwide.
The commencement of patient enrollment in this Phase III trial is a testament to the dedicated efforts of Akeso’s research and development team, as well as the invaluable collaboration with clinical investigators and research sites. This milestone underscores Akeso’s ongoing dedication to advancing innovative therapies that have the potential to significantly impact patient lives.
“We are thrilled to announce the enrollment of the first patient in our Phase III HARMONi-GI6 trial,” said [Insert Name and Title of Akeso Representative, if available in the original PR, otherwise omit or use a generic placeholder like “a spokesperson for Akeso”]. “Colorectal cancer remains a significant global health challenge, and we believe that ivonescimab’s unique dual-targeting mechanism holds considerable promise for improving treatment outcomes in the first-line setting. This trial represents a critical step in our mission to bring transformative therapies to patients battling this disease.”
Akeso is committed to rigorous scientific investigation and patient-centric development. The company will closely monitor the progress of the HARMONi-GI6 trial and looks forward to sharing data as it becomes available. This initiative further solidifies Akeso’s position as a key player in the development of novel cancer treatments.
About Colorectal Cancer:
Colorectal cancer (CRC) is a common type of cancer that begins in the large intestine (colon) or the rectum. It is a leading cause of cancer-related deaths worldwide. While advancements in screening and treatment have improved survival rates, there remains a critical need for more effective therapeutic options for patients with advanced metastatic disease.
About Ivonescimab (AK112):
Ivonescimab is a novel bispecific antibody developed by Akeso. It is designed to simultaneously target and inhibit vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2). VEGF plays a crucial role in promoting the growth of new blood vessels that supply tumors with oxygen and nutrients, while Ang-2 can contribute to tumor growth and immune evasion. By blocking both pathways, ivonescimab aims to disrupt tumor angiogenesis and potentially enhance anti-tumor immunity.
About Akeso:
Akeso is a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative biotherapeutics for the treatment of major diseases, with a focus on oncology and autoimmune diseases. The company leverages its advanced technology platforms and extensive R&D expertise to bring novel, high-quality medicines to patients worldwide.
Forward-Looking Statements:
This press release contains forward-looking statements regarding the development and potential benefits of ivonescimab. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, the uncertainties inherent in clinical development, regulatory approvals, and commercialization. Akeso undertakes no obligation to update any forward-looking statements.
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PR Newswire Healthring published ‘Akeso Announces First Patient Enrolled in the Phase III Trial（AK112-312/HARMONi-GI6）of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer’ at 2025-07-16 01:47. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.