Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combined with Ligufalimab (CD47) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC), Compared to Pembrolizumab

HONG KONG,Oct. 31,2024 --Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized,controlled,multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC).

The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab,utilizing PD-1/L1 monoclonal antibody therapy as a positive control,and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore,it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development.

In 2022,there were 770,000 new cases of head and neck cancer globally,with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately,the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options,the median overall survival (OS) remains below one year.

Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. There is a critical unmet need for more effective therapies to helpHNSCC patients achieve long-term survival.

At the 2024 European Society for Medical Oncology (ESMO) Congress,Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits,particularly for HNSCC patients,who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies,positioning it as a potentially new immunotherapy option for HNSCC patients.

About Ligufalimab (AK117)

AK117,independently developed by Akeso,is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα,in order to enhance the phagocytic activity of phagocytes on tumor cells,thereby inhibiting the growth of tumors.

Currently,several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors,as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles,with no observed dose-limiting toxicity events. Additionally,the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine,as well as the international multicenter Phase II clinical study of AK117 for treating MDS,are both ongoing with patient enrollment.

About Ivonescimab (AK112/SMT112)

Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories,including the United States,Canada,Europe,Japan,Central America,South America,the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently,ivonescimab's first indication has been approved in China,and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer,hepatocellular carcinoma and colorectal 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.