Core Insights - Elicio Therapeutics has received supportive FDA feedback on the design of the Phase 3 study for ELI-002, which includes key elements such as dose, schedule, patient population, and primary endpoint analysis [1][2] - The Phase 2 randomized study of ELI-002 is fully enrolled, with an interim analysis of disease-free survival expected in the first half of 2025; positive results could lead to rapid advancement into Phase 3 development [1][2] Company Overview - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer treatment, particularly targeting high-prevalence cancers like mKRAS-positive pancreatic and colorectal cancers [3] - The company aims to leverage recent clinical successes in personalized cancer vaccines to create effective off-the-shelf vaccines [3] - Elicio's lead program, ELI-002, targets common KRAS mutations, which are responsible for approximately 25% of all solid tumors [3][4] Product Details - ELI-002 is an investigational AMP cancer vaccine designed to target cancers driven by KRAS mutations, utilizing Elicio's proprietary AMP technology [4] - The ELI-002 7P formulation is currently being studied in a Phase 1/2 trial for patients with mKRAS-driven pancreatic cancer, aiming to provide immune response coverage against seven common KRAS mutations [5] Technology Platform - Elicio's AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, enhancing the education and activation of immune cells [6][8] - The platform has shown potential in preclinical models to drive therapeutic immune responses with increased magnitude, function, and durability [6][8] - Originally developed at the Massachusetts Institute of Technology, the AMP platform has broad potential for advancing various cancer treatment initiatives [7]
Elicio Therapeutics Reaches Alignment with FDA on ELI-002 Registrational Strategy