Updated Phase 1 data from Elicio’s AMPLIFY-201 program reported a 16.3-month median recurrence-free survival and 28.9-month median overall survival across the full study population with earlier, smaller-peptide formulations of its KRAS-targeted vaccine platform. That backdrop sets the stage for the company’s next move into the neoadjuvant setting in pancreatic cancer.
Elicio plans an investigator-initiated, multi-center Phase 1 trial testing ELI-002 7P with mFOLFIRINOX, with or without an anti-PD-1 agent, in borderline and resectable PDAC. The study, led out of Memorial Sloan Kettering and funded by the Lustgarten Foundation, will enroll 20 patients in two 10-patient cohorts. First patients are expected in the first half of 2026. The design separates chemotherapy plus vaccine from the addition of PD-1 blockade, aiming to parse whether a KRAS-directed vaccine can convert PDAC’s immune-cold microenvironment into one amenable to checkpoint inhibition while preserving feasibility in pre-surgical timelines.
Strategically, this is an early-move bet on timing and practicality. Personalized vaccines in PDAC have produced promising signals post-surgery, but they are operationally heavy and slow. Elicio’s off-the-shelf KRAS 7-peptide construct targets seven common KRAS mutations, trading personalization for speed, broader eligibility, and simpler logistics—attributes that matter when cycles of FOLFIRINOX are compressed between diagnosis and resection. Positioning the program as an IIT reduces cash burn and aligns the readout with influential academic validators, while the dual-cohort structure generates a signal on whether PD-1 adds enough incremental biology to justify the added toxicity and cost in a population historically refractory to single-agent checkpoint therapy.
For sites, the burden will sit in orchestration. Neoadjuvant PDAC windows are tight, and this protocol layers subcutaneous vaccination plus optional PD-1 onto multi-agent chemotherapy, biopsy schedules, and surgical planning. Expect intensive translational sampling—tumor and peripheral blood—to characterize T-cell priming, trafficking, and clonality, and to connect immunogenicity with surgical endpoints such as R0 resection rates and margin status. Central lab capacity for immunomonitoring and ctDNA will be critical. CROs and vendors with established neoadjuvant logistics and chain-of-custody for fresh tissue will be advantaged, but site staffing constraints and OR scheduling remain gating risks. For Elicio, off-the-shelf supply mitigates some operational fragility relative to autologous vaccines; however, dependable manufacturing, cold-chain delivery, and coordination with PD-1 sourcing will still define site uptake.
Regulators are increasingly receptive to earlier-intervention immuno-oncology when backed by robust translational evidence, but PDAC remains a high bar. With only 20 patients, the study will be powered for safety, feasibility, and immunologic signal rather than hard efficacy. Any observed shifts in tumor-infiltrating lymphocytes, KRAS-specific T-cell responses, ctDNA clearance, or pathologic response could frame a subsequent randomized neoadjuvant or perioperative trial with clinically anchored endpoints (event-free survival, R0 rates, or MRD-guided outcomes). Competitive pressure is rising from multiple angles: personalized neoantigen vaccines in adjuvant PDAC, emerging KRAS G12D inhibitors, and combinations exploring stromal modulation to unlock checkpoint activity.
Key watch items over the next 12–18 months include protocol finalization and site activation pace, selection of the specific anti-PD-1 agent, biomarker, and tissue-handling requirements that can make or break site participation, and clarity on primary endpoints and decision criteria to expand. If the IIT demonstrates clean feasibility with a convincing immunologic bridge to surgical outcomes, Elicio gains a practical development path and a differentiated operational story in PDAC. If not, the program may need to pivot back to post-operative minimal residual disease, where timelines and biology may be more forgiving.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
