ONVAX-01 Personalized Peptide Nanovaccine Plus Anti-PD-1 Antibody and Chemotherapy Phase 1/2 Trial in Advanced Pancreatic Cancer Recruiting (NCT07637786, Late June 2026 Listing) — Targets KRAS Neoantigens in a Tumor with 90% KRAS-Mutation Prevalence
A Phase 1/2 study (NCT07637786) of ONVAX-01, a personalized peptide nanovaccine, in combination with an anti-PD-1 antibody and standard-of-care chemotherapy in patients with advanced pancreatic cancer began recruiting in late June 2026. The trial design has participants receive doses of the nanovaccine along with intravenous infusions of an anti-PD-1 checkpoint inhibitor plus chemotherapy, with serial imaging and blood-marker monitoring for tumor response. ONVAX-01 sits in the same broad therapeutic space as Elicio Therapeutics' ELI-002 7P (which missed its Phase 2 AMPLIFY-7P primary disease-free survival endpoint on June 15) but with a different delivery vehicle (nanoparticle self-assembly versus amphiphile-modified CpG oligonucleotide adjuvant). KRAS mutations drive approximately 90% of pancreatic ductal adenocarcinoma cases and 50% of colorectal cancers, making KRAS-targeting peptide vaccines one of the highest-impact unmet targets in solid-tumor oncology. The peptide nanovaccine modality has roots in 2022 case-report literature on neoantigen nanovaccine immunotherapy in advanced pancreatic cancer and broader nanovaccine work using DP7-C antimicrobial peptide as carrier-plus-adjuvant.