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Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Globenewswireยท 2025-08-05 11:00
Core Insights - Elicio Therapeutics announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2 AMPLIFY-7P trial for ELI-002 7P without modifications, indicating preliminary efficacy signals [1][5] - The final disease-free survival (DFS) analysis is expected in Q4 2025, and the company plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the Phase 3 study [2][5] - ELI-002 7P is an investigational immunotherapy targeting seven KRAS mutations, which are prevalent in 88% of PDAC patients and 25% of all solid tumors [3][8] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company utilizes its proprietary Amphiphile (AMP) technology to enhance the immune response against cancer, aiming for durable cancer immunosurveillance [4][9] - ELI-002 is designed as an off-the-shelf vaccine candidate targeting common KRAS mutations, with potential benefits including low cost and rapid availability for patients [4][6] Clinical Trial Details - The AMPLIFY-7P trial is a 2:1 randomized, open-label study involving 144 patients across 24 U.S. sites, comparing ELI-002 7P monotherapy to standard of care [2][5] - ELI-002 7P treatment consists of six doses followed by an eight-week observation period and four booster doses [2] - The trial aims to improve DFS in patients with PDAC who have undergone local therapy, surgery, and chemotherapy [2] Future Plans - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer and additional mKRAS-positive cancers [6] - The company is also developing other off-the-shelf therapeutic cancer vaccine candidates, such as ELI-007 and ELI-008, targeting BRAF-driven cancers and p53 hotspot mutations [6]