Elicio Therapeutics Announces Preliminary Data from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P in Patients with mKRAS-driven Solid Tumors at the 2024 ASCO Annual Meeting

• ELI-002 7P administered as a monotherapy was well tolerated and able to generate a ~100x mKRAS-specific expanded T cell response relative to baseline levels
  
• ELI-002 7P generated an mKRAS-specific T cell response in 100% of patients including responses targeting all mKRAS mutations enrolled (G12D, V, R and G13D)
• mKRAS-specific T cells were polyfunctional with 66.7% (4/6) of evaluable patients having both CD8+ and CD4+ responses at the 4.9 mg Phase 2 dose level
• Tumor biomarker reductions were observed in 5/7 (71%) of evaluable patients at the 4.9 mg Phase 2 dose level
• ELI-002 7P was shown to induce antigen-spreading with increased T cell responses targeting non-immunizing, personalized tumor neoantigens in 6/6 (100%) of evaluable patients at the 4.9 mg Phase 2 dose level
  

BOSTON, May 23, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced preliminary data from the ongoing AMPLIFY-7P Phase 1a study of its off-the-shelf investigational therapeutic cancer vaccine candidate, ELI-002 7P, in a poster presentation at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL. The preliminary data showed ELI-002 7P was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose (“RP2D”).

The AMPLIFY-7P study is evaluating the 7-peptide formulation of Elicio’s cancer vaccine candidate, ELI-002 7P, in patients with mKRAS-driven solid tumors that are positive for minimal residual disease following standard locoregional treatment. ELI-002 7P was developed with Elicio’s proprietary lymph node-targeting Amphiphile (“AMP”) technology designed to stimulate an immune response against the seven KRAS mutations (G12D, G12R, G12V, G12A, G12C, G12S and G13D) that drive 25% of all solid tumors. 

“KRAS mutated cancers are difficult to target in part due to the number of diverse mutations and bypass resistance mechanisms. We are encouraged by the first data from the ongoing AMPLIFY-7P trial, which demonstrate ELI-002 7P has a favorable safety profile and early antitumor effects that correlate with induction of T cells specific for multiple KRAS mutations potentially providing broader coverage for patients,” said Craig E. Devoe, M.D., MHCM., Chief, Division of Medical Oncology & Hematology, R.J. Zuckerberg Cancer Center, and Scientific Investigator, Northwell Health.