Elicio Therapeutics, Inc. announced positive interim clinical data from the ongoing Phase 1 (AMPLIFY-201) study of its lead asset, ELI-002, an investigational therapeutic cancer immunotherapy. This study evaluated ELI-002 2P, a 2-peptide formulation designed to treat cancers driven by G12D and G12R mutations in KRAS. ELI-002 was studied as a monotherapy in patients with mutant KRAS-driven tumors who are at high risk for relapse due to detection of minimal residual disease (MRD) following standard surgery and chemotherapy (NCT04853017).

The data will be presented in a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, a hybrid event taking place online and at McCormick Place in Chicago from June 2-6, 2023. ELI-002 2P was well-tolerated, with no dose limiting toxicity or cytokine release syndrome across 5 cohorts that evaluated ascending doses from 0.1 to 10.0 mg of the adjuvant Amph-CpG. Responses were observed at all dose levels, with a high proportion of patients having tumor biomarker reduction including a subset with clearance.

Robust mKRAS-specific T cell responses were induced in 87% of patients with an average of a 56-fold [range 2-423-fold] increase directly ex vivo.