HONG KONG, Oct. 19, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") and its partner Summit Therapeutics Inc. jointl y announced an international multicenter Phase II clinical study (SMT112-216 / AK112-216 / NCT078 77194).
Built on Akeso's first-in-class immuno-oncology (IO) cornerstone therapy ivonescimab (PD-1/VEGF bispecific antibody), the study will assess the efficacy and safety of multiple treatment regimens, including the combination of ivonescimab with Akeso's first-in-class bispecific antibody cadonilimab (PD-1/CTLA-4 bispecific antibody), in previously untreated patients with advanced clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or the established international standard-of-care comparator regimen of nivolumab plus ipilimumab.
Cadonilimab is the world's first approved immuno-oncology bispecific antibody and the only PD-1/CTLA-4 bispecific antibody to have received regulatory approval. It is currently approved for three indications: first-line gastric cancer, first-line cervical cancer, and recurrent or metastatic cervical cancer.
Cadonilimab is being evaluated in 13 Phase III/registrational clinical studies, including two international multicenter trials. In addition, dozens of Phase I/II studies have been conducted across more than 30 tumor types, including renal cell carcinoma, demonstrating robust anti-tumor activity and a favorable safety profile.
Currently, regimens combining a PD-1 inhibitor with a CTLA-4 inhibitor, such as nivolumab plus ipilimumab, and those combining a PD-1 inhibitor with a tyrosine kinase inhibitor (TKI), such as pembrolizumab plus axitinib, represent established first-line standards of care for advanced renal cell carcinoma internationally. Building on ivonescimab as a cornerstone therapy, combinations with the next-generation IO agent cadonilimab, a PD-1/CTLA-4 bispecific antibody, and additional agents will allow further exploration of the synergistic, complementary and differentiated effects across distinct targets and mechanisms of action. This approach has the potential to further improve clinical benefit and offer patients with advanced renal cell carcinoma more diverse and precise novel treatment options.
Early clinical studies have shown that both cadonilimab and ivonescimab demonstrate promising antitumor activity with manageable safety profiles in renal cell carcinoma, providing a strong rationale for further evaluation of their combination in advanced disease.
Earlier this year, Summit announced a clinical trial collaboration to evaluate the safety and efficacy of ivonescimab in combination with casdatifan, a HIF2a inhibitor from Arcus Biosciences, in ccRCC, including first-line metastatic disease.
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.
SOURCE Akeso, Inc.
