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

• 68% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD4+ T cells
  
• 84% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD8+ T cells
• The majority of ELI-002-treated patients tested had antigen spreading where induced T cells targeted additional patient-specific tumor mutations beyond mKRAS
• The majority of patients who received a ELI-002 booster dose were observed to have durable mKRAS-specific T cell response with increased memory T cell phenotype
• Preclinical studies of ELI-007 and ELI-008 demonstrated that AMP vaccination resulted in a 42-fold to a several-hundred-fold increased immune response when compared to conventional vaccines
• Initial ELI-002 7P clinical data expected to be presented in the second quarter of 2024

BOSTON, April 05, 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 that it will be sharing pipeline updates for all investigational candidates at the upcoming American Association for Cancer Research (“AACR”) Annual Meeting, taking place in San Diego, California from April 5-10, 2024. Among the data presented will be updated immunogenicity data from the ongoing Phase 1 (AMPLIFY-201) study of ELI-002, an off-the-shelf investigational therapeutic cancer vaccine for patients with mutant Kirsten rat sarcoma (“mKRAS”)-driven pancreatic and colorectal cancers. Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.

In the first-in-human, Phase 1 (AMPLIFY-201) study, ELI-002 was given as adjuvant treatment for patients with high relapse-risk mKRAS-driven colorectal cancer (“CRC”) and pancreatic ductal adenocarcinoma (“PDAC”). A majority of patients who received the booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline.   ELI-002 demonstrated several key advantages, including lymph node-targeted vaccine design, potent immunogenicity with balanced CD4⁺ and CD8⁺ T cell responses, HLA-agnostic activity, and targeting of mKRAS antigens critical for tumor survival. The mKRAS-specific CD4 and CD8 T cells generated by ELI-002 exhibited increased cytotoxic function and development of favorable memory phenotype. Regulatory T cell responses were not detected. Antigen spreading was observed following ELI-002 vaccination, with patient-specific tumor neoantigen-directed T cell responses detected in the majority of evaluated patients using direct ex vivo immunogenicity assays.