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Elicio Therapeutics Advances mKRAS-Targeting Cancer Vaccine, Anticipates Phase 2 Results in H1 2025

8 months ago2 min read

Key Insights

  • Elicio Therapeutics anticipates completing enrollment for the AMPLIFY-7P Phase 2 trial of ELI-002 in Q4 2024, with interim disease-free survival (DFS) analysis expected in H1 2025.

  • Data presented at SITC 2024 highlighted durable T cell responses and antigen spreading in KRAS mutant tumors following ELI-002 Phase 1a trial.

  • Updated relapse-free survival (RFS) and overall survival (OS) data from the AMPLIFY-201 study will be presented at the ESMO Immuno-Oncology Congress in December 2024.

Elicio Therapeutics is making strides in the development of its novel immunotherapies for cancer treatment. The company's lead program, ELI-002, is currently being evaluated in a randomized Phase 2 study (AMPLIFY-7P) involving 135 patients with pancreatic ductal adenocarcinoma. Enrollment is anticipated to be completed in Q4 2024, with a formal interim analysis of disease-free survival (DFS) expected in H1 2025.

Clinical Data Highlights

At the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting, Elicio presented a poster showcasing Phase 1a translational data from the AMPLIFY-7P trial. The data demonstrated durable T cell responses and antigen spreading in patients with KRAS mutant tumors treated with ELI-002. These findings suggest a potential DFS benefit, warranting further investigation in the ongoing Phase 2 trial.
Elicio is also set to present updated relapse-free survival (RFS) and overall survival (OS) data from the AMPLIFY-201 study at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress in December 2024. This presentation will provide further insights into the long-term efficacy of ELI-002 in patients with mKRAS-driven solid tumors.

Pipeline Expansion and Financial Stability

In addition to ELI-002, Elicio is advancing ELI-007 and ELI-008, targeting mBRAF and mTP53 mutations, respectively. The company plans to provide additional information about these programs and their clinical development plans in H1 2025.
Elicio's financial position has been strengthened through recent funding, which is expected to support operations into Q2 2025, beyond the anticipated AMPLIFY-7P interim analysis. This financial stability will allow the company to continue its clinical development programs and explore new opportunities in cancer immunotherapy.

About ELI-002 and the Amphiphile Platform

ELI-002 is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. The vaccine is designed to elicit a strong T cell response against mutant KRAS antigens, potentially leading to durable cancer immunosurveillance.
Elicio's Amphiphile (AMP) technology enhances the delivery of immunotherapeutics to the lymph nodes, the "brain center" of the immune system. This targeted delivery aims to improve the education, activation, and amplification of cancer-specific T cells, resulting in a more potent and durable immune response.
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