Elicio Therapeutics Advances Phase 2 Study, Continues Without Modifications.

Elicio Therapeutics announced that an Independent Data Monitoring Committee recommended the continuation of its Phase 2 AMPLIFY-7P study without modifications, following a positive interim review of safety and efficacy data for ELI-002 7P in treating mutant KRAS-driven pancreatic ductal adenocarcinoma. The company plans to proceed with a final disease-free survival analysis in Q4 2025 and aligns with the FDA on the Phase 3 study design.

Elicio Therapeutics, Inc. (Nasdaq: ELTX), a clinical-stage biotechnology company, has received a positive recommendation from an Independent Data Monitoring Committee (IDMC) to continue its Phase 2 AMPLIFY-7P study without modifications. The recommendation is based on the interim review of safety and efficacy data for ELI-002 7P in treating mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC).

The IDMC's positive recommendation indicates that ELI-002 7P has shown preliminary signals of efficacy. The study is designed to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to the standard of care (observation) in improving disease-free survival (DFS) in patients with PDAC in the adjuvant setting post local therapy. The study enrolled 144 patients at 24 U.S. sites [1].

Elicio plans to proceed with the final DFS analysis in the fourth quarter of 2025. The company has previously reached alignment with the FDA on the key elements of the planned pivotal Phase 3 study design. Following the final DFS analysis, Elicio intends to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study [1].

ELI-002 7P is an investigational, off-the-shelf, immunotherapy vaccine administered by subcutaneous injection targeting seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors. The company remains blinded to the trial clinical efficacy outcomes [1].

Elicio's current cash runway extends into the first quarter of 2026, past the anticipated final DFS analysis. The company's pipeline includes additional off-the-shelf therapeutic cancer vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively [1].

References:
[1] https://www.biospace.com/press-releases/elicio-therapeutics-announces-positive-recommendation-by-idmc-to-continue-eli-002-7p-randomized-phase-2-study-in-pancreatic-cancer-without-modifications-to-final-analysis