Elicio Therapeutics, Inc. (Nasdaq: ELTX) has announced that it has received supportive feedback from the U.S. Food and Drug Administration (FDA) regarding its registrational strategy for ELI-002, an investigational cancer vaccine targeting KRAS-mutated cancers. This positive feedback, obtained during an End of Phase 1 Type B meeting, covers key aspects of the planned Phase 3 study design, including dose, dosing schedule, target patient population, and the primary endpoint of disease-free survival (DFS).
Alignment on Phase 3 Trial Design
The FDA's feedback supports Elicio's proposed Phase 3 study design, aligning with their therapeutic approach. Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, stated that the alignment with the FDA on the principal elements of the Phase 3 study design is a significant step forward in bringing this cancer immunotherapy to patients. The target patient population for the Phase 3 trial is KRAS-mutated pancreatic adenocarcinoma, with disease-free survival, based on modified RECIST criteria, as the primary study endpoint.
ELI-002: Targeting KRAS Mutations
ELI-002 is an Amphiphile (AMP) cancer vaccine designed to target cancers driven by mutations in the KRAS gene, a prevalent driver in many human cancers. The vaccine comprises AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant, administered via subcutaneous injection. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.
AMPLIFY-7P Phase 2 Study
The ongoing Phase 2 AMPLIFY-7P study is fully enrolled and is on track for a pre-planned interim data analysis in the first half of 2025. This randomized study is evaluating ELI-002 in patients with mKRAS-driven pancreatic cancer. Robert Connelly, Chief Executive Officer of Elicio, believes that ELI-002 could have a transformational role in the management of difficult-to-treat mKRAS cancers as an off-the-shelf monotherapy treatment for patients who completed neoadjuvant, perioperative or adjuvant chemotherapy and yet remain at elevated risk of disease recurrence. Encouraging clinical results have demonstrated a favorable safety profile and a strong correlation between T cell response, tumor biomarker reductions, and reduced risk of recurrence or death.
Clinical Development and Future Plans
The earlier 2-peptide formulation of ELI-002 (ELI-002 2P) was studied in the Phase 1 AMPLIFY-201 trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). The current ELI-002 7P formulation is being studied in the Phase 1/2 AMPLIFY-7P trial (NCT05726864) in patients with mKRAS-driven pancreatic cancer. If the interim results from the Phase 2 AMPLIFY-7P study are positive, Elicio intends to rapidly advance the program into a Phase 3 study, which could potentially support regulatory approval and a Biologics License Application (BLA) filing.
About Elicio Therapeutics
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies to prevent the recurrence of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio's Amphiphile (AMP) technology aims to enhance the education, activation, and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients.
