Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer

HONG KONG, July 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer.

Pancreatic cancer remains one of the most challenging types of tumors to find effective treatments for. While immunotherapies have demonstrated significant efficacy in different types of of solid tumors, pancreatic cancer's unique immune evasion mechanisms and its highly immunosuppressive tumor microenvironment (TME) have rendered it resistant to current therapies. As a result, previous Phase III studies on using immunotherapies as first-line treatments for metastatic pancreatic cancer have mostly failed. To date, no immunotherapy has been approved for first line metastatic pancreatic cancer.

Ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomized, controlled, multi-center Phase III trial is a key component of Akeso's broader strategy to address the significant unmet clinical needs in global oncology.

Pancreatic cancer is an extremely aggressive form of malignancy that often result in poor patient prognosis. Its global incidence is on the rise, and the mortality rate closely mirrors the incidence, resulting in alarmingly low overall survival rates. In 2022, approximately 511,000 new cases of pancreatic cancer were diagnosed worldwide, and 467,000 deaths were recorded. Early diagnosis remains challenging, with around 80% of patients being diagnosed at an advanced stage. Even those diagnosed with early-stage or locally advanced disease may see progression to metastatic pancreatic cancer within a year following surgery or other treatments. Current first-line treatments are predominantly chemotherapies and have showed very limited success, with a median overall survival (OS) of less than one year.

PD-1 and VEGF are often co-expressed in the tumor microenvironment. As a PD-1/VEGF bispecific antibody, Ivonescimab can accumulate in the TME and effectively block both the PD-1 and the VEGF signaling pathways. While these pathways are independently active, they are also complementary. Inhibition of both PD-1 and VEGF enhances immune cells' ability to target and destroy tumor cells. In addition, ligufalimab binds to CD47 on tumor cells, disrupting the interaction with signal regulatory protein alpha (SIRPα) on phagocytic cells. This process boosts phagocytosis and inhibits tumor growth. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumor activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer.

Professor Yu Xianjun, Director of Fudan University Shanghai Cancer Center, Professor Ying Jie'er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators of HARMONi-GI2 study.

Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are 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.

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