Elicio Therapeutics Reports Initial Disease-Free Survival Data from AMPLIFY-7P Phase 1a Study of ELI-002 7P

Elicio Therapeutics, Inc., a clinical-stage biotechnology firm focused on developing innovative immunotherapies for cancer treatment, has announced encouraging preliminary results from its ongoing AMPLIFY-7P Phase 1a study. The study centers on ELI-002 7P, an off-the-shelf investigational therapeutic cancer vaccine designed for patients with mKRAS-driven solid tumors, particularly after standard locoregional treatments.

As of the May 24, 2024, data cutoff, the 14 patients diagnosed with minimal residual disease had yet to reach the median disease-free survival (DFS) endpoint. Notably, those receiving the Phase 2 dose of 4.9mg AMP-peptide demonstrated significant promise, with their median DFS still undetermined at this early juncture in the trial.

The AMPLIFY-7P study focuses on the 7-peptide formulation of ELI-002 7P. Data highlighted the performance of different dosages: patients administered the 4.9mg dose (n=8) had not reached the median DFS, in stark contrast to the 12.6-week median DFS observed in patients taking the 1.4mg dose (n=6). Furthermore, patients who showed a reduction in tumor biomarker levels experienced no progression events, compared to an 11.0-week median DFS for those whose biomarkers did not respond to the treatment. Importantly, patients exhibiting an above-median T cell response to ELI-002 saw no progression events.

Dr. Christopher Haqq, Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, expressed optimism regarding these early findings. He noted that the strong T cell response and reductions in tumor biomarker levels correlated with decreased risk of progression or mortality. These promising results mirror those observed in the earlier AMPLIFY-2P trial, published in Nature Medicine. Haqq also mentioned that further clinical data updates are anticipated later in 2024, with a randomized Phase 2 interim analysis expected in the first quarter of 2025.

ELI-002, Elicio’s lead product candidate, is an investigational Amphiphile (AMP) cancer vaccine targeting cancers driven by mKRAS gene mutations, a common driver of various human cancers. The vaccine employs AMP technology, incorporating AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant. This combination is designed for off-the-shelf subcutaneous administration. ELI-002 2P, a 2-peptide formulation, is being studied in an ongoing Phase 1 trial in patients with high-risk mKRAS-driven solid tumors post-surgery and chemotherapy. Meanwhile, ELI-002 7P, a 7-peptide formulation, is under investigation in a Phase 1/2 trial targeting mKRAS-driven pancreatic cancer. This 7-peptide formulation aims to elicit an immune response against seven prevalent KRAS mutations found in 25% of all solid tumors, thereby expanding the potential patient population for ELI-002.

Elicio Therapeutics is committed to advancing its pipeline of novel lymph node-targeted immunotherapies to combat some of the most aggressive cancers. By leveraging their AMP technology, Elicio aims to enhance the immune system’s cancer-fighting capabilities by delivering therapeutic payloads directly to the lymph nodes. This approach seeks to optimize the lymph nodes' natural ability to educate, activate, and amplify cancer-specific T cells, which are crucial for identifying and destroying tumor cells. The company's research and development pipeline includes off-the-shelf therapeutic cancer vaccines such as ELI-002 for mKRAS-driven cancers, ELI-007 for BRAF-driven cancers, and ELI-008 for p53 hotspot mutations.

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