On August 10, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported the opening of the investigator-initiated ("IIT") Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable PDAC. The multi-center IIT is being conducted by MSK Cancer Center and is being funded by a strategic partnership between The Lustgarten Foundation and Break Through Cancer.
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"The activation of this study marks an important milestone as we prepare to evaluate the potential of ELI-002 7P across multiple stages of pancreatic cancer," said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. "Building on the complete responses observed in patients with metastatic PDAC treated with sequential ELI-002 7P followed by checkpoint inhibitor and chemotherapy, this study prospectively evaluates the combination beginning in the neoadjuvant setting and continuing after surgery. We hope to generate important clinical insights into ELI-002 7P’s potential to harness the immune system and improve surgical outcomes and long-term survival for patients facing this devastating disease."
Kevin Soares, MD, Assistant Attending Surgeon Hepatopancreatobiliary Service, MSK and Principal Investigator of the Phase 1 study added, "Despite advances in the treatment of pancreatic cancer, patients with resectable and borderline resectable disease continue to face a high risk of recurrence, highlighting the need for new therapeutic strategies. This trial offers an important opportunity to investigate how ELI-002 7P may reshape the tumor immune environment when initially combined with neoadjuvant therapy, while offering the potential to generate valuable translational data that could inform future treatment strategies."
The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant PDAC. Participants will receive ELI-002 7P with standard chemotherapy, mFOLFIRINOX, with or without tislelizumab, an anti-PD1 checkpoint inhibitor, starting before surgery. Throughout treatment, researchers plan to collect tumor tissue and blood samples to better understand immune activation, characterize changes within the tumor microenvironment, and identify biomarkers that could guide future clinical trials.
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.
ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further inform a refined Phase 3 development strategy. Elicio intends to initiate a Phase 1 study in metastatic PDAC designed to provide a rapid assessment of clinical activity using an open label design to assess the objective response rate including partial and complete radiographic responses. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic PDAC and the adjuvant PDAC Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.
(Press release, Elicio Therapeutics, AUG 10, 2026, View Source [SID1234669923])