Akeso Enrolls First Patient in Phase III Trial for Triple-Negative Breast Cancer Treatment

Akeso Biopharma (HKEX: 9926.HK), a leading biopharmaceutical company, has announced the enrollment of the first patient in its multicenter, randomized, double-blind Phase III clinical trial of ivonescimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This trial, known as HARMONi-BC1/AK112-308, is led by Professor Xu Binghe, a renowned breast cancer expert and academician of the Chinese Academy of Engineering, from the Cancer Hospital of the Chinese Academy of Medical Sciences.

The initiation of this trial marks a significant milestone in Akeso's comprehensive development plan for ivonescimab, a first-in-class PD-1/VEGF bispecific antibody. Ivonescimab has already demonstrated promising clinical data in various indications, including non-small cell lung cancer (NSCLC) and recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The enrollment of the first patient in this Phase III trial for TNBC further underscores Akeso's commitment to advancing innovative therapies for cancer patients and expanding the clinical development of ivonescimab.



TNBC is an aggressive subtype of breast cancer with a high recurrence rate and poor prognosis. Despite advancements in treatment options, there is still a significant unmet need for more effective therapies, particularly in the first-line setting. Ivonescimab, in combination with chemotherapy, has the potential to address this unmet need and provide a novel and effective treatment option for TNBC patients.

The enrollment of the first patient in this Phase III trial is a crucial step in Akeso's clinical development plan for ivonescimab. It demonstrates the company's commitment to advancing the timeline for ivonescimab's regulatory approval and market penetration in the TNBC indication. If the Phase III trial confirms the promising results seen in early-stage trials, Akeso could offer a novel and effective treatment option for TNBC patients, further expanding its revenue streams.

In conclusion, Akeso's enrollment of the first patient in the Phase III clinical trial of ivonescimab in combination with chemotherapy for first-line treatment of TNBC is a significant milestone in the company's quest to advance innovative therapies for cancer patients. The successful completion of this trial, along with other ongoing and planned trials, will provide valuable data to support the regulatory approval of ivonescimab in different indications, including TNBC. Once approved, ivonescimab has the potential to generate significant revenue streams for Akeso, further enhancing the company's investment appeal.