Elicio Therapeutics Reports Positive Results in Ongoing Phase 2 AMPLIFY-7P Trial with ELI-002 7P
BOSTON, December 11, 2025 (GLOBE NEWSWIRE) – Elicio Therapeutics, Inc. (Nasdaq: ELTX), a forward-looking biotechnology firm, has announced significant findings from the ongoing Phase 2 AMPLIFY-7P trial. The analysis highlights the ability of ELI-002 7P to induce immune responses beyond the primary target, mKRAS, demonstrating the potential for a broader, personalized anti-tumor approach.
Key Findings from the Phase 2 AMPLIFY-7P Trial
In a subset analysis of the Phase 2 trial, 87% (13 out of 15) of evaluated patients showed effective antigen spreading. This phenomenon involves the immune system's ability to target non-mKRAS neoantigens that were not originally included in the treatment, indicating a promising expansion of immune response.
This finding aligns with prior data collected during Phase 1 trials, where treatment also yielded engaging T cell responses to personalized tumor antigens. ELI-002 7P appears capable of amplifying the immune response, providing a multi-faceted attack on various tumor markers, which may enhance durability against tumors.
Understanding Antigen Spreading
Antigen spreading, or epitope spreading, occurs when the immune response expands from the targeted antigens to additional tumor-specific antigens. This process initiates as tumor cells are destroyed, releasing tumor proteins that trigger a more extensive immune response.
The results from the AMPLIFY-7P study suggest that such enhanced immunity can potentially thwart tumor evasion, offering a promising avenue for more durable treatment outcomes. In the trial, 90 patients were evaluated, with 15 selected for antigen spreading analysis based on their blood samples and tumor genetic data.
Detailed Efficacy Results
- Patients Evaluated: 90
- Patients Demonstrating T Cell Responses to Non-mKRAS Antigens: 13 out of 15
- T Cell Response Rates:
- Phase 1: 84% (21/25)
- Phase 2: 99% (89/90)
- Median Number of Non-mKRAS Antigens Tested: 10 (range 5 to 12)
These findings suggest that a significant majority of patients may develop robust anti-tumor immunity through ELI-002 7P, potentially mitigating the risk of cancer relapse.
Insights from Leadership
Robert Connelly, CEO of Elicio Therapeutics, expressed his satisfaction with the trial results: “We are extremely pleased to observe induction of personalized neoantigen-specific T cell responses in a significant majority of assessed Phase 2 patients, suggesting that ELI-002 7P possesses the potential to generate broad tumor-specific immunity.”
Connelly emphasized the implications of these findings for personalized cancer treatment, highlighting the broader clinical applications of ELI-002 7P beyond just targeting mKRAS.
About Elicio Therapeutics and ELI-002
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is advancing the field of cancer immunotherapy. The company’s lead candidate, ELI-002, is designed to treat high-prevalence cancers driven by mutations in the KRAS gene. The proprietary Amphiphile (AMP) technology aims to improve the immune system's education and activation, enhancing the efficacy of cancer treatments.
ELI-002 is under investigation in the AMPLIFY series of clinical trials focusing on patients who are at high risk of cancer relapse. Elicio's innovative approach to immunotherapy aims to provide rapid access to effective treatment options, showcasing their commitment to confronting prevalent cancer types.