Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting - Seite 2

"Earlier data published in Nature Medicine demonstrate that our off-the-shelf lymph node-targeted cancer vaccine candidate, ELI-002, induces memory T cell responses. With longer follow-up, we observed response durability and added antigen-spreading to the mechanism of ELI-002, where we saw additional personal neoantigen responses join together with mutated KRAS responses creating a precision response that may lead to enhanced clinical activity,” said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. “Following positive early findings from the 2-peptide formulation of ELI-002, we initiated a randomized Phase 2 study of our 7-peptide formulation, ELI-002 7P, in adjuvant pancreatic cancer (NCT05726864). We expect to share interim 7-peptide ELI-002 data from the Phase 1A arm in the second quarter of 2024.”

Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics, added, “These preclinical data demonstrate that ELI-007 and ELI-008 induce strong tumor antigen-specific T cell responses targeting BRAF and p53 mutations, respectively. ELI-007 and ELI-008 induced highly potent and functional T cell responses, often ten to a hundred-fold higher than comparator. These data build on previous data showing that the AMP strategy can improve the potency of vaccine immunotherapy by delivering vaccine components directly to the lymph nodes, the ‘command center’ of the immune system. These data support the broad applicability of the technology and represent promising therapeutic product opportunities targeting mutations shared in a large fraction of human solid cancers.”

Poster Presentation Summary

Presentation Title: Durable immunogenicity of ELI-002 2P in AMPLIFY-201: Lymph node targeted mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer
Session Title: First-in-Human Phase I Clinical Trials 1
Session Date and Time: Monday, April 8, 2024, 1:30 PM – 5:00 PM PT

• ELI-002 2P consists of 2 Amph-modified mKRAS peptide antigens, Amph-G12D and Amph-G12R (Amph-Peptides 2P), and an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909).
• ELI-002 2P was administered as an adjuvant treatment for patients with high relapse-risk mutant KRAS PDAC and CRC.
• 25 patients received ELI-002 2P at 1.4 mg of Amph-Peptides 2P and Amph-CpG-7909 at 5 escalating dose levels: 0.1, 0.5, 2.5, 5, and 10 mg.
• Peripheral blood and circulating tumor DNA (“ctDNA”) or serum tumor antigen were collected longitudinally to assess T cell immunogenicity and reductions in clinical tumor biomarkers.
• A majority of patients who received ELI-002 booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline. Durable responses were associated with increased memory T cell phenotype compared to baseline.
• ELI-002 induced increased mKRAS-specific CD4 and CD8 T cells with cytotoxic function, associated with increased memory phenotype in a majority of patients.
• CD4⁺ T regulatory cells were not induced after ELI-002 2P immunization.
• Antigen spreading was observed with T cell responses to patient-specific tumor mutations (not mKRAS) after ELI-002 2P vaccination in a majority of patients tested.
• Data demonstrated several advantages of ELI-002 including lymph node-targeted vaccine design, potent immunogenicity with durable and balanced CD4+ and CD8+ T cell responses, increased T cell cytotoxic function, and antigen spreading to induce T cells targeting additional tumor mutations beyond mKRAS.