Plasmid-DNA vaccines encoding neoantigens, typically delivered by electroporation — the platform behind Geneos' and several academic programs.
[RECRUITING · PHASE2 · Geneos Therapeutics] This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on p…
Geneos Therapeutics has launched a randomized, open-label Phase II study (NCT07722741) for GNOS-PV02, a personalized neoantigen DNA vaccine combined with plasmid-encoded IL-12 (INO-9012). The trial targets patients with high-risk hepatocellular carcinoma (HCC) who are disease-free post-resection, aiming to prevent recurrence. This marks a significant clinical step for Geneos in validating its DNA-based platform in a adjuvant setting.
A study on plasmid DNA electroporation for neoantigen vaccines reveals that the technique sequesters activated CD8+ T cells in the treated muscle tissue rather than promoting tumor infiltration. While the method induces strong local immune gene activation, flow cytometry showed neoantigen-specific T cells accumulating at the vaccination site instead of the tumor. This suggests that electroporation-induced tissue remodeling may limit therapeutic efficacy by trapping effector cells away from the cancer.
GT Biopharma’s GNOS-PV01, a personalized DNA vaccine targeting patient-specific mutations in MGMT-unmethylated glioblastoma, is being evaluated in a Phase 1 study published in Nature Cancer. The trial utilizes multi-regional tumor sampling to address high heterogeneity, aiming to induce immune responses against dozens of neoantigens rather than single targets. This approach addresses the lack of efficacy seen with prior immunotherapies in this aggressive cancer subtype.