Geneos Therapeutics Reveals Favorable Phase 1/2 Results for Customized Cancer Vaccine in GT-30 Trial

Geneos Therapeutics has reported successful results from its GT-30 clinical trial, showcasing the safety and effectiveness of a personalized therapeutic cancer vaccine (PTCV) for patients with advanced hepatocellular carcinoma (HCC). The study, published in Nature Medicine and presented at the 2024 AACR Annual Meeting, involved 36 patients who received a combination treatment of GNOS-PV02, a DNA-based PTCV with the cytokine adjuvant IL-12, and pembrolizumab, a PD-1 inhibitor. 

The trial achieved its primary goals of safety and immunogenicity and exceeded its secondary efficacy target based on the observed response rate (ORR). The ORR for the GT-30 trial stands at 30.6%, which includes three complete and eight partial responses, a significant improvement over the historical control rate for pembrolizumab monotherapy. Importantly, adverse events were mild, with no severe toxicities observed. The study's findings are particularly notable given that it targeted HCC, a cancer type with a low tumor mutational burden and an immune-excluded phenotype, which typically poses a challenge for immunotherapy. 

Despite the small sample size, the results are considered a significant step forward in cancer vaccine development. The immunological analysis revealed that the vaccine induced new T cell responses to specific tumor neoantigens in all evaluated patients, a critical factor for anti-tumor activity. 

Furthermore, the GT-30 trial demonstrated a correlation between the number of vaccine epitopes and the number of reactive epitopes post-vaccination, suggesting that a higher number of targeted neoantigens can enhance the vaccine's effectiveness. This is a significant advantage over other personalized vaccine platforms that may be limited in the number of neoantigens they can target. The company's proprietary GT-EPIC™ platform is utilized to create PTCVs by targeting neoantigens unique to each patient's tumor, offering a highly personalized approach to cancer treatment. Geneos Therapeutics is now planning a potentially pivotal clinical trial for advanced HCC, highlighting the promising therapeutic potential of their personalized cancer vaccines.

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