Elicio Therapeutics Unveils Promising Phase 1a Data For ELI-002 7P In mKRAS Tumors

Elicio Therapeutics ELTX has announced that preliminary data from their AMPLIFY-7P Phase 1a Study of ELI-002 7P in patients with mKRAS-driven solid tumors was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose ("RP2D").

Elicio Therapeutics is a clinical-stage biotechnology company focused on developing innovative lymph node-targeted immunotherapies to treat aggressive cancers. Given the firm's expertise in materials science, immunology and oncology, it plans to forge a new path forward for cancer treatment by utilizing its diverse capabilities to fulfill its mission of amplifying the potential of immunotherapies, empowering patients to fight cancer with full force.

The initial findings from its study are encouraging, given that KRAS mutated cancers are difficult to target in part due to the number of diverse mutations and bypass resistance mechanisms.

"We are encouraged by the first data from the ongoing AMPLIFY-7P trial, which demonstrate ELI-002 7P has a favorable safety profile and early antitumor effects that correlate with induction of T cells specific for multiple KRAS mutations potentially providing broader coverage for patients, said Craig E. Devoe, M.D., MHCM., chief of the Division of Medical Oncology & Hematology and the R.J. Zuckerberg Cancer Center, and scientific investigator at Northwell Health.

Elicio Therapeutics Pipeline

Elicio Therapeutics' lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (AMP) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene — a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio Therapeutics' AMP technology, consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy. ELI-002 7P (7 peptide formulation) is being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations(G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

Compelling Results From The Ongoing AMPLIFY-7P Phase 1a Study

The company reports that the efficacy of ELI-002 7P as a treatment solution was successful in several instances, demonstrating the versatility of the drug and its ability to provide a strong T cell response. The preliminary data findings from the ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P include:

• ELI-002 7P administered as a monotherapy was well tolerated and able to generate a ~100x mKRAS-specific expanded T cell response relative to baseline levels
• ELI-002 7P generated an mKRAS-specific T cell response in 100% of patients including responses targeting all mKRAS mutations enrolled (G12D, V, R and G13D)
• mKRAS-specific T cells were polyfunctional with 66.7% (4/6) of evaluable patients having both CD8+ and CD4+ responses at the 4.9 mg Phase 2 dose level
• Tumor biomarker reductions were observed in 5/7 (71%) of evaluable patients at the 4.9 mg Phase 2 dose level
• ELI-002 7P was shown to induce antigen-spreading with increased T cell responses targeting non-immunizing, personalized tumor neoantigens in 6/6 (100%) of evaluable patients at the 4.9 mg Phase 2 dose level

In speaking about these findings, Christopher Haqq, MD, PhD, executive vice president, head of Research and Development and chief medical officer at Elicio Therapeutics, stated, "These early immunogenicity and biomarker response data from ELI-002 7P continue to provide encouraging results showing that our lymph node-targeted approach generates a robust and differentiated T cell response that strongly correlates with tumor biomarker reductions."

"Across two trials, ELI-002 has demonstrated an ability to generate a robust T cell response against all mKRAS mutations of enrolled patients as well as T cell responses against non-immunizing personalized tumor neoantigens. ELI-002's broader KRAS mutation coverage and higher T cell responses with the 7-peptide vaccine at the Phase 2 dose holds promise for the high unmet need of patients with KRAS-mutated tumors," Haqq said.

The AMPLIFY-7P Phase 1a Study data findings of ELI-002 7P were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4, 2024, in Chicago, IL. The ASCO Annual Meeting is considered the premier international forum for presenting scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world.

An Immunotherapeutics Company

Founded as a spin-out from the Massachusetts Institute of Technology (MIT), Elicio Therapeutics leverages the research of Professor Darrell Irvine, a Howard Hughes Investigator and expert in biomedical engineering and immunology. The company’s main innovation, the Amphiphile (AMP) platform, delivers immunotherapeutics directly to the body's lymph nodes to enhance the immune system’s cancer-fighting mechanisms. By delivering cancer immunotherapies to the center of the immune response, Elicio Therapeutics intends to optimize the natural ability of the lymph nodes to educate, activate, and amplify cancer-specific T cells.

Elicio Therapeutics’ mission is to give patients battling cancer the best possible outcome. The firm's leadership and scientific advisory board are composed of determined and experienced individuals who are committed to engineering lymph node–targeted immunomodulators, adjuvants, and vaccines for an array of aggressive cancers.

The Path Forward

Elicio Therapeutics' recent findings are encouraging news and a tailwind for the firm's innovation activities. Given the applicability of ELI-002 7P in treating patients with differing cancers, this is a milestone moment for Elicio Therapeutics and an encouraging step forward in the firm's research and development and eventual commercialization of its treatment offering. As such, the benefit that Elicio Therapeutics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance.

Featured photo by CDC on Unsplash.

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