Elicio Therapeutics Announces Positive Interim Data from the Phase 1 Study of an Investigational Therapeutic Cancer Immunotherapy, ELI-002, in Patients with High Relapse Risk Pancreatic and Colorectal Cancer at the ASCO Annual Meeting

• ELI-002 was shown to be well-tolerated with no dose limiting toxicity or cytokine release syndrome
  
• A high proportion of patients had tumor biomarker reduction (77%) with 32% having complete clearance
  
• Robust mKRAS-specific T cell responses induced in 87% of patients
  

BOSTON, June 03, 2023 (GLOBE NEWSWIRE) -- Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today 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.

“mKRAS-specific T cells have been shown to mediate anti-tumor efficacy, which prompted us to assess ELI-002 in high relapse-risk patients where tumor biomarkers can provide an early efficacy signal,” said Eileen M. O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology; Co-Director, Medical Initiatives, David M. Rubenstein Center for Pancreatic Cancer Research; Section Head, Hepatopancreaticobilary & Neuroendocrine Cancers, Memorial Sloan Kettering Cancer Center (MSK). “We are encouraged by the findings which showed that ELI-002 was well-tolerated. The trial enabled patients to enroll with minimal disease which reduces the chances of an immunosuppressive tumor environment and increases the ratio of T cells to target tumor cells.”