Geneos Therapeutics shares data from phase 1/2 trial for cancer vaccine

Betsy Goodfellow | April 8, 2024 | News story | Research and Development Cancer, Geneos Therapeutics, Oncology, clinical trial 

Geneos Therapeutics has announced that it has published positive safety, immunogenicity and efficacy data from the full cohort of patients enrolled in its phase 1/2 GT-30 clinical trial for its personalised therapeutic cancer vaccine.

The data from the trial was published in Nature Medicine, and is included in a paper entitled Personalized Neoantigen Vaccine and Pembrolizumab in Advanced Hepatocellular Carcinoma: A phase 1/2 trial. The 36-patient, single-arm, open-label, multi-centre, phase 1/2 study assessed GNOS-PV02 and pembrolizumab in second-line patients with advanced hepatocellular carcinoma (HCC) which has been previously treated with a multi-tyrosine kinase inhibitor.

The trial met its primary endpoints of safety and immunogenicity, as well as the secondary endpoint of efficacy based on observed response rate (ORR).

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Personalised therapeutic cancer vaccine (PTCV)-related adverse events were all limited to grades 1 and 2 with no dose-limiting toxicities or grade 3 adverse events observed. The most common adverse events were injection site reactions.

Niranjan Sardesai PhD, chief executive officer and president of Geneos Therapeutics, commented: “Other recent industry trials have tested personalised cancer vaccines in patients with highly immune-sensitive tumour phenotypes and no measurable disease. In marked contrast, the GT-30 trial assesses PTCVs in HCC, a cancer with very low tumour mutational burden and an immune-excluded phenotype, and in patients with significant late-stage unresectable and metastatic disease. Despite the small size of this study, our results are important for the advancement of the field. We have not only met endpoints for safety, immunogenicity and clinical efficacy based on ORR in this difficult-to-treat setting, but our mechanism of action data traces and confirms every step, from vaccination to tumour reduction, required to explain the immunological basis for the observed clinical responses.”

Betsy Goodfellow

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