Akeso Initiates Phase III Clinical Trial for Triple-Negative Breast Cancer Treatment

Akeso Launches Phase III Clinical Trial for TNBC Treatment

Akeso, Inc., a prominent biopharmaceutical company listed on the Hong Kong Stock Exchange (9926.HK), recently announced a significant milestone in oncology research. The company has successfully enrolled its first patient in a multicenter, randomized, double-blind Phase III clinical trial focused on ivonescimab in conjunction with chemotherapy. This trial aims to provide first-line treatment for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) through the study designated as HARMONi-BC1/AK112-308.

Understanding ivonescimab’s Role

Ivonescimab is a unique, first-in-class bispecific antibody that targets PD-1 and VEGF. This innovative approach aims to enhance the mechanisms of cancer immunotherapy by targeting pathways involved in tumor growth and immune evasion. This Phase III trial aims to investigate the effectiveness of ivonescimab combined with standard chemotherapy options for patients battling advanced stages of TNBC—a notoriously aggressive form of breast cancer that lacks targeted treatment options.

Leading the Study: Expertise on Board

The trial is being led by Professor Xu Binghe, a distinguished breast cancer researcher and an academician at the Chinese Academy of Engineering, at the Cancer Hospital of the Chinese Academy of Medical Sciences. His leadership underscores the trial's potential as a vital part of advancing treatment methodologies for this challenging cancer.

Preliminary efficacy data presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting indicated that ivonescimab in combination with chemotherapy yields substantial therapeutic benefits while demonstrating a favorable safety profile. These findings enhance optimism about the drug's potential to revolutionize treatment strategies for TNBC patients.

Comprehensive Development Strategy

Akeso has strategically embedded ivonescimab within a broad development program aimed at redefining cancer immunotherapy. The drug has already received approval in China for use in cases of non-small cell lung cancer (NSCLC) that are resistant to EGFR-TKI. Additionally, a new drug application for ivonescimab as a standalone therapy for PD-L1 positive NSCLC is currently under review, having been awarded priority status in China.

The company’s ongoing research agenda portrays its commitment to innovation, with several international multicenter Phase III trials either ongoing or set to launch. These include studies focusing on various forms of lung cancer and biliary tract cancer, further showcasing Akeso's broad scope in cancer treatment development.

Global Competitive Edge

Akeso, founded in 2012, has built a robust research and development infrastructure, establishing itself as a globally competitive entity. With a focus on innovative medical solutions, the company boasts an impressive pipeline of over 50 assets targeting major health challenges such as cancer, metabolic diseases, and autoimmune disorders. Among these, 22 candidates are currently in clinical trials, including 11 bispecific and multispecific antibodies.

As Akeso embarks on this critical Phase III trial, it encapsulates a growing trend in the pharmaceutical industry towards leveraging breakthroughs in immunotherapy. The ongoing developments in Akeso's research pipeline are poised to offer new hope to patients battling cancer and to contribute to evolving therapy landscapes.

For further details on Akeso's missions and its array of innovative drugs, visit Akeso Bio's Corporate Profile. Staying at the forefront of biopharmaceutical advancements, Akeso strives to improve patient outcomes and transform treatment paradigms worldwide.