Elicio Therapeutics Presents Early Data from AMPLIFY-7P Phase 1a Study at 2024 ASCO

Elicio Therapeutics Inc., a clinical-stage biotechnology firm focused on developing innovative immunotherapies for cancer treatment, has released promising preliminary data from the ongoing AMPLIFY-7P Phase 1a study of its investigational therapeutic cancer vaccine, ELI-002 7P. This data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, Illinois.

Key Findings:
The results indicate that ELI-002 7P, administered as a monotherapy, was well tolerated by patients and significantly boosted mKRAS-specific T cell responses—up to 100 times relative to baseline levels. Impressively, the treatment elicited a specific T cell response in all patients, targeting all included mKRAS mutations (G12D, G12V, G12R, and G13D). Furthermore, 66.7% of evaluable patients exhibited both CD8+ and CD4+ T cell responses at the 4.9 mg Phase 2 dose level.

Tumor biomarker reductions were observed in 71% of evaluable patients at the 4.9 mg dose, indicating a direct correlation between T cell response and reduction in tumor biomarkers. Additionally, ELI-002 7P demonstrated antigen-spreading capability, with enhanced T cell responses targeting non-immunizing, personalized tumor neoantigens in all evaluable patients at this dose.

Study Overview:
AMPLIFY-7P is assessing the 7-peptide formulation of ELI-002 7P in patients with mKRAS-driven solid tumors who have minimal residual disease post-standard locoregional treatment. This formulation utilizes Elicio's proprietary lymph node-targeting Amphiphile (AMP) technology, aimed at stimulating an immune response against the seven KRAS mutations responsible for 25% of all solid tumors.

Dr. Craig E. Devoe, Chief of the Division of Medical Oncology & Hematology at R.J. Zuckerberg Cancer Center, expressed optimism, stating that the early data shows ELI-002 7P's potential in targeting diverse KRAS mutations and overcoming resistance mechanisms. The data demonstrates favorable safety and early antitumor effects, promising broader coverage for patients.

Expert Insights:
Christopher Haqq, Elicio’s Executive VP and Chief Medical Officer, emphasized that the lymph node-targeted approach of ELI-002 7P generates a robust and differentiated T cell response, aligning with significant tumor biomarker reductions. Across multiple trials, ELI-002 has shown efficacy in generating strong T cell responses against all enrolled mKRAS mutations and personalized tumor neoantigens.

Further Developments:
As of the December 18, 2023, data cutoff, polyfunctional mKRAS-specific T cells were observed in 100% of evaluable patients, with both CD8+ and CD4+ responses induced in 66.7% of patients at the recommended Phase 2 dose (RP2D) of 4.9 mg. Notably, biomarker reductions were seen in 71% of patients at this dose, with clearance observed for all common KRAS mutations enrolled in the study.

The study also noted the absence of dose-limiting toxicities, treatment-related serious adverse events, or cytokine release syndrome, underscoring the treatment's safety profile.

About ELI-002:
ELI-002 is Elicio's lead investigational product, a novel AMP cancer vaccine designed to target cancers driven by mKRAS gene mutations. The 7-peptide formulation of ELI-002 is currently being evaluated in a Phase 1/2 trial for mKRAS-driven pancreatic cancer. The vaccine aims to provide immune response coverage against seven prevalent KRAS mutations, potentially benefiting a significant patient population.

Conclusion:
Elicio Therapeutics continues to advance its pipeline of lymph node-targeted immunotherapies, with promising early data for ELI-002 7P showing potential in addressing the high unmet needs of patients with KRAS-mutated tumors. The company's ongoing research and clinical trials aim to harness and amplify the immune system's natural cancer-fighting abilities, potentially transforming cancer immunotherapy.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!