Akeso Announces First Patient Dosed in Phase I Trial of Personalized mRNA Vaccine AK154 as Monotherapy or in Combination with Cadonilimab or Ivonescimab for Adjuvant Treatment of Pancreatic Cancer

HONG KONG, Nov. 10, 2025 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926. HK) is pleased to announce that the first patient has been dosed in a Phase I clinical trial evaluating the personalized mRNA vaccine AK154. This trial is investigating AK154 both as a monotherapy and as a combination with the company's first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), for the adjuvant treatment of pancreatic cancer following surgical resection.

AK154 is Akeso's first mRNA-based therapeutic candidate to enter clinical development. This achievement marks a significant breakthrough for the company in the field of mRNA technology, following its established leadership in multi-specific antibodies, and entry into the clinic for its antibody-drug conjugates (ADCs).

AK154 is a personalized neoantigen vaccine developed by Akeso using its mRNA platform. It designs sequence-specific mRNA vaccines by sequencing tumor tissue and identifying immunogenic mutations with high affinity. This approach aims to overcome the "cold tumor" phenotype seen in pancreatic cancer.

AK154 shows a synergistic therapeutic effect with Akeso's bispecific antibodies in enhancing anti-tumor immunity. Preclinical data demonstrated strong immunogenicity, potent anti-tumor activity, and a favorable safety profile. The combination of AK154 with cadonilimab or ivonescimab offers potentially promising new therapeutic options for pancreatic cancer patients.

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. 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

SOURCE Akeso, Inc.