Akeso Enrolls First Patient in Phase 3 Trial of Ivonescimab and Ligufalimab for HNSCC, Compared to Pembrolizumab

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) has commenced the enrollment process for the first patient in its Phase III clinical trial (AK117-302) focused on head and neck squamous cell carcinoma. This study aims to assess the efficacy of the PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's CD47 monoclonal antibody ligufalimab (AK117), compared to pembrolizumab, for first-line treatment in patients with PD-L1 positive (CPS≥1) recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC).

This AK117-302 study marks a significant achievement as it is the first Phase III trial worldwide to test a CD47 monoclonal antibody treatment for solid tumors. It is also the fifth Phase III trial for ivonescimab, and the third to compare ivonescimab with pembrolizumab. This trial highlights Akeso's dedication to advancing cancer immunotherapy and establishing new global standards for cancer treatment. The study also emphasizes the company's aim to expand the benefits of their product portfolio to a larger pool of cancer patients globally through strategic clinical development.

In 2022, there were 770,000 new cases of head and neck cancer worldwide, with 84,000 cases in China alone. Squamous cell carcinoma of the head and neck (HNSCC) constitutes over 90% of these cases. The five-year survival rate for patients with recurrent or metastatic HNSCC is a mere 3.6%. Despite advancements in targeted therapies and immunotherapies, the median overall survival (OS) for these patients remains under one year.

Pembrolizumab is currently the standard first-line treatment for R/M HNSCC as recommended by both CSCO and NCCN guidelines. However, many patients do not respond adequately to this treatment, and the overall survival benefit is limited. There is a pressing need for more effective treatments to improve long-term survival for HNSCC patients.

At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso presented promising initial data on the combination therapy of ivonescimab and ligufalimab. The combination showed significant tumor reduction and survival benefits, especially for HNSCC patients who need rapid tumor shrinkage. The preliminary efficacy data from this combination therapy exceeded those of previous PD-1 studies, suggesting it could become a new immunotherapy option for HNSCC patients.

About Ligufalimab (AK117):
Developed independently by Akeso, AK117 is a next-generation humanized lgG4 anti-CD47 antibody that does not cause hemagglutination. It binds to CD47 on tumor cells, blocking its interaction with SIRPα, thereby enhancing the phagocytic activity of phagocytes on tumor cells and inhibiting tumor growth. Several phase II clinical trials are in progress to explore the potential of AK117 in combination with azacitidine for hematological tumors, and AK117 alone or combined with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles without dose-limiting toxicity events. Ongoing studies include the Chinese Phase II clinical trial for first-line treatment of unfit AML using AK117 with venetoclax and azacitidine and an international multicenter Phase II trial of AK117 for treating MDS.

About Ivonescimab (AK112/SMT112):
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug developed by Akeso. Known as SMT112 in Summit Therapeutics' license territories including the United States, Canada, Europe, Japan, Central America, South America, the Middle East, and Africa, ivonescimab has received marketing approval from NMPA for treating EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Its first indication has been approved in China, and Akeso is conducting six registrational trials versus anti-PD-1/L1 therapies. Multiple clinical trials for ivonescimab, covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma, and colorectal cancer, are ongoing.

About Akeso:
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing, and commercialization of world-class innovative biological medicines. Founded in 2012, Akeso has established a comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody). The company has developed a robust pipeline with over 50 innovative assets in fields such as cancer, autoimmune disease, inflammation, and metabolic disease. Among these, 22 candidates are in clinical trials, including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates. Five new drugs are commercially available, and five new drugs across seven indications are under regulatory review. Akeso aims to develop first-in-class and best-in-class drugs, providing affordable therapeutic antibodies for patients worldwide and continuously creating commercial and social value to become a leading global biopharmaceutical enterprise.