Akeso Doses First Patient in Phase 1 Trial of Personalized mRNA Vaccine AK154 for Pancreatic Cancer
HONG KONG — Nov. 10, 2025 /PRNewswire/ — Akeso, Inc. (HKEX: 9926.HK) today announced a significant expansion of its clinical pipeline with the dosing of the first patient in a Phase 1 clinical trial evaluating AK154, its personalized messenger RNA (mRNA) vaccine. This milestone marks the company’s first mRNA-based therapeutic candidate to enter clinical development, signifying a major advance in its mRNA platform technology.
The Phase 1 trial will investigate AK154 as an adjuvant treatment for pancreatic cancer following surgical resection. This cutting-edge mRNA vaccine is being tested both as a monotherapy and in combination with Akeso’s leading bispecific antibodies: cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF).
Harnessing mRNA to Target “Cold Tumors”
AK154 is a personalized neoantigen vaccine developed by Akeso using its proprietary mRNA platform. The design utilizes sequence-specific mRNA vaccines created by sequencing tumor tissue and identifying immunogenic mutations with high affinity. This highly specific mRNA approach aims to overcome the “cold tumor” phenotype often observed in pancreatic cancer, where the tumor microenvironment is typically resistant to immune attack. The development of this mRNA therapeutic moves Akeso beyond its established leadership in multi-specific antibodies and its recent clinical entry into antibody-drug conjugates (ADCs).
Synergistic mRNA Combination Potential
Preclinical data strongly supports the rationale for combining this mRNA vaccine with Akeso’s bispecific antibodies. The mRNA vaccine demonstrated strong immunogenicity, potent anti-tumor activity, and a favorable safety profile.
The combination of AK154 mRNA with either cadonilimab or ivonescimab is hypothesized to offer a powerful synergistic therapeutic effect in enhancing anti-tumor immunity. If successful, this mRNA regimen could provide a promising new therapeutic option for pancreatic cancer patients, a population with historically limited treatment alternatives and poor prognoses.
Source:
https://www.prnewswire.com/news-releases/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-302610059.html
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