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Geneos Therapeutics Unveils Promising Phase 1/2 Findings for GT-30 Trial of Personalized Cancer Vaccine

Monday, April 08, 2024

Geneos Therapeutics, a company focusing on biotherapeutics in clinical stages, has revealed positive findings from its GT-30 clinical trial in Nature Medicine.

The trial, titled "Personalized Neoantigen Vaccine and Pembrolizumab in Advanced Hepatocellular Carcinoma: A phase 1/2 trial," details the investigation of GNOS-PV02, a DNA plasmid encoded PTCV, in combination with pembrolizumab (a PD-1 inhibitor) and DNA plasmid encoded IL-12 (a cytokine adjuvant). This study enrolled 36 patients with advanced hepatocellular carcinoma (HCC) who had previously undergone treatment with a multi-tyrosine kinase inhibitor. The trial successfully met its primary endpoints of safety and immunogenicity, as well as its secondary endpoint of efficacy, as evidenced by the observed response rate (ORR).

Adverse events associated with PTCV were mostly Grades 1 and 2, with no severe toxicities observed. The most frequent adverse events were injection site reactions. Importantly, the addition of PTCV to a PD-1 inhibitor did not lead to a significant decrease in patient safety and tolerability.

The ORR for GT-30 was 30.6%, which included three complete responses and eight partial responses, demonstrating statistical significance compared to historical controls of pembrolizumab monotherapy. The median overall survival (mOS) in GT-30 was 19.9 months, an improvement over previous studies of pembrolizumab monotherapy. Immunological analyses showed the induction of new T cell responses to vaccine-encoded neoantigens in all evaluated patients, suggesting a promising mechanism of action for the observed clinical responses.

At the 2024 American Association for Cancer Research (AACR) Annual Meeting, Geneos presented updated longitudinal circulating tumor DNA (ctDNA) biomarker data from the GT-30 trial, demonstrating significant reductions in ctDNA levels correlated with ongoing survival.

Dr. Niranjan Sardesai, CEO and president of Geneos, highlighted the importance of the study's results, particularly in a cancer type like HCC with low tumor mutational burden and an immune-excluded phenotype. Dr. Ildiko Csiki, chief medical officer of Geneos, emphasized the promising therapeutic potential of personalized cancer vaccines, especially in combination with PD-1 inhibitors.

The success of the GT-30 trial underscores the potential of personalized cancer vaccines in enhancing clinical responses to immunotherapy, offering hope for improved outcomes in cancer patients.



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