Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutics’ AMPLIFY-201 Phase 1 Solid Tumor Study Of ELI-002

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By Jeremy Golden, Benzinga

Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the second and third leading causes of cancer death, respectively. Pancreatic and colorectal cancers are often Kirsten rat sarcoma (KRAS) mutated and are incurable when tumor DNA or protein persists or recurs after curative intent therapy.

KRAS mutations are among the most prevalent human cancers. For these cancers, caused by a mutation of the KRAS gene, clinical-stage biotechnology company Elicio Therapeutics Inc. (NASDAQ: ELTX) is developing a pipeline of novel immunotherapies for treatment.

Founded in 2011, Elicio Therapeutics has developed an innovative pipeline of cancer immunotherapies addressing critical unmet needs. Three vaccine candidates are currently in Elicio Therapeutics pipeline: ELI-002, ELI-007 and ELI-008. Elicios lead clinical program, ELI-002, is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. It was designed to stimulate an immune response against the seven KRAS mutations driving 25% of solid tumors.

ELI-002 2P has been studied in a phase 1 dose-escalation study in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. After early findings from AMPLIFY-201 were released, ELI-002 was the subject of a publication in Nature Medicine.

The paper Lymph Node Targeted, mKRAS-specific Amphiphile Vaccine in Pancreatic and Colorectal Cancer: The phase 1 AMPLIFY-201 Trial details expanded and updated results that point to the power of Elicio Therapeutics use of precision vaccines, immunomodulators and cell-based therapies to assemble cancer-killing immune responses against solid tumors.

Originally presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2023 AACR Special Conference on Pancreatic Cancer, the data detailed in the publication is as of September 6, 2023. It is based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional treatment.

When tumor DNA or protein persists or recurs after treatment, patients with pancreatic and colorectal cancers are unfortunately not left with many options and are often incurable, said study author Shubham Pant, M.D., Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. These are promising early findings from the AMPLIFY-201 study with follow up ongoing. Most patients reduced their tumor biomarkers with some having complete clearance following treatment with ELI-002.

The lymph node-targeted cancer vaccine candidate induced direct ex vivo mKRAS-specific T cell responses in 84% of patients, with 59% of patients demonstrating a response with two key types of T cells: helper cells and killer cells, according to Christopher Haqq, M.D., Ph.D., Elicios Executive Vice President, Head of Research and Development, and Chief Medical Officer. Past studies have not produced this large a fraction of patient response, this high a magnitude of a response or the expansion of both key populations of T cells, he said.

Importantly, these T cell responses were specific to tumor-driver mutant KRAS neoantigens, correlated with reduced risk of relapse and we saw a pool of memory T cells form that we believe hold promise to confer long-term protection, Haqq said. We look forward to progressing ELI-002 into a randomized phase 2 trial as a monotherapy for patients with PDAC.

ELI-002 7P is currently being studied in AMPLIFY-7P, a phase 1/2 trial in patients with high relapse risk mKRAS-driven solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and possibly reducing the chance of bypass resistance mechanisms.

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