- Becomes the 7th International Registrational Clinical Trial for Ivonescimab
- Clinical Trial Site Activations in the United States Expected to Begin Q4 2026
HONG KONG, Oct. 21, 2026 /PRNewswire/ — Akeso, Inc. (HKEX: 9926.HK) today announced that Summit Therapeutics Inc. (NASDAQ: SMMT), its global partner for ivonescimab, has entered into a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate ivonescimab in a registration-enabling Phase II/III study in biliary tract cancer (BTC). The new study, EA2251 (NCT07765433), is designed to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in the first-line treatment of patients with advanced BTC.
This marks the 7th international registrational Phase II/III clinical trial for ivonescimab. Previously, the Phase III HARMONi-GI1 study conducted by Akeso in China, evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for patients with BTC, achieved a positive overall survival (OS) result that was both statistically significant and clinically meaningful.
“Biliary tract cancer is often diagnosed at an advanced stage, and despite recent progress, there is a need for more effective first-line options that can extend survival and improve disease control,” said lead investigator Deirdre J. Cohen, MD, MS, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of the Gastrointestinal Oncology Program for the Mount Sinai Health System and Co-Director of the Center of Excellence for Pancreatic Cancer at the Mount Sinai Tisch Cancer Center. “EA2251 will explore a novel therapeutic approach in the front-line setting by evaluating ivonescimab with chemotherapy against current immunotherapy-based standards of care.”
“We are delighted to see the global clinical development of ivonescimab further expand into the field of biliary tract cancer. Against the background of the positive OS results from the Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy, the advancement of the Phase III EA2251 study by a leading cooperative oncology group in the United States further strengthens our confidence in achieving global success,” said Dr. Michelle Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso. “We look forward to the progress of ivonescimab’s registrational clinical development worldwide and its potential to become a superior treatment option for patients with biliary tract cancer globally as early as possible.”
“We are honored to collaborate with ECOG-ACRIN on EA2251 as we continue to expand the development program for ivonescimab in areas of meaningful unmet need,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “The sponsorship and conduct of this registration-enabling study by a leading cooperative oncology group underscores the scientific interest in evaluating ivonescimab in difficult-to-treat cancers, including BTC, and supports Summit’s commitment to building a robust body of clinical evidence across multiple tumor types and treatment settings.”
EA2251 is the second Phase III registrational clinical study of ivonescimab in BTC. Detailed results from HARMONi-GI1 (AK112-309), which evaluated ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with BTC, will be presented at the European Society for Medical Oncology 2026 Congress (ESMO 2026) on Sunday, October 25, during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT).
About ECOG-ACRIN
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is one of the world’s leading scientific organizations, known for innovative multicenter clinical trials involving adults with cancer or at risk of developing it. Its expansive membership network includes over 1,400 hospitals and cancer centers across the United States and around the world, involving nearly 21,000 research professionals and advocates. To learn more, visit www.ecog-acrin.org and follow ECOG-ACRIN on X, Facebook, LinkedIn, YouTube, Instagram, and BlueSky, or call 215-789-3631.
About Ivonescimab
Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world’s first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab.
Building on its strong clinical profile in the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company’s IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide.
More than 18 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).
Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion.
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, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms.
Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the Company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multi-specific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval.
Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world.
Forward-Looking Statements
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 the 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 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.
