Phase 2 Pancreatic Cancer Trial Begins with First Patient Dosed

Elicio Therapeutics, a clinical-stage biotech firm, has initiated a Phase 2 study named AMPLIFY-7P for its investigational therapeutic cancer vaccine, ELI-002 7P. The first patient has been dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research in New York. The vaccine targets seven common KRAS mutations associated with 25% of solid tumors, including 88% of pancreatic ductal adenocarcinoma (PDAC) patients. This approach differs from other KRAS-targeted treatments, which focus on fewer mutations and may lead to resistance due to the development of escape mutants.
Christopher Haqq, Elicio’s EVP and Chief Medical Officer, highlighted that while most pancreatic cancers have KRAS mutations, only a small percentage are treatable with small molecules. The Phase 2 study is expected to build on positive results from a previous 2-peptide formulation of ELI-002, which showed a significant reduction in tumor biomarkers and strong T cell responses linked to a lower risk of relapse and death.
Elicio plans to present the AMPLIFY-7P trial's design at the ASCO Gastrointestinal Cancers Symposium from January 18-20, 2024, in San Francisco. Initial data from the Phase 1A arm of the ELI-002 7P monotherapy will be shared in the first half of 2024. ELI-002 is an innovative AMP therapeutic immunotherapy aimed at mutant KRAS-driven cancers, with the 7P formulation covering seven prevalent KRAS mutations, potentially increasing the treatable patient population and reducing resistance mechanisms.
ELI-002 2P is currently in a Phase 1 trial for patients with high relapse risk mKRAS-driven solid tumors. Elicio Therapeutics is focused on developing novel immunotherapies to target aggressive cancers by leveraging their expertise in immunology and immunotherapy. Their AMP immunotherapies are designed to engage the lymph nodes, where the immune response is coordinated.