Elicio Therapeutics, Inc. (ELTX), a clinical-stage biotechnology company, announced that it has completed enrollment in its AMPLIFY-7P Study.
AMPLIFY-7P is a phase II study of ELI-002, a cancer vaccine targeting mutant KRAS (mKRAS)-driven pancreatic ductal adenocarcinoma in patients who are at high risk of relapse following surgery. In this trial, 135 patients have been enrolled, randomized 2:1 to receive subcutaneous injections of ELI-002 7P versus standard of care observation.
The primary endpoint of the study is disease-free survival (DFS), with secondary endpoints focused on serum tumor biomarker responses, overall survival, and vaccine immunogenicity.
The first patient was dosed in January 2024, and an interim DFS analysis is expected in the first half of 2025.
Dr. Christopher Haqq, Elicio's Executive Vice President and Chief Medical Officer, highlighted the speed of enrollment, which exceeded expectations.
The company looks forward to the pre-planned interim data analysis as it continues to explore the potential of ELI-002 as an off-the-shelf treatment for mKRAS-driven PDAC.
ELI-002 utilizes Elicio's proprietary Amphiphile (AMP) platform, designed to enhance immune responses. The AMPLIFY-7P study is expected to be completed by November 2026.
In addition to ELI-002, Elicio is advancing other AMP peptide vaccines, including ELI-007, which targets BRAF gene mutations found in melanoma, colorectal cancer (CRC), and lung cancer, and ELI-008, which targets p53 hotspot mutations, in solid tumors such as melanoma, CRC, and non-small cell lung cancer (NSCLC). Both vaccines aim to generate T-cell immunity for tumor elimination.
ELTX closed Monday's trading at $5.20, up 2.16%
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