Akeso Initiates First-in-Human Trial of Personalised mRNA Vaccine AK154 for Pancreatic Cancer

11 November 2025 | Tuesday | News


Akeso has dosed the first patient in a Phase I study of AK154 — its first mRNA-based therapeutic — exploring use alone and in combination with bispecific antibodies cadonilimab and ivonescimab to boost anti-tumour immunity and improve post-surgical outcomes in pancreatic cancer.
Image Source : Public Domain

Image Source : Public Domain

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.

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