Announcement • Aug 11

Elicio Therapeutics Announces Activation Of Investigator-Initiated Phase 1 Study Of Neoadjuvant ELI-002 7P For Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics, Inc. announced the opening of the investigator-initiated Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable pancreatic ductal adenocarcinoma. The multi-center investigator-initiated trial is being conducted by Memorial Sloan Kettering Cancer Center and is being funded by a strategic partnership between The Lustgarten Foundation and Break Through Cancer. The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant pancreatic ductal adenocarcinoma. 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. 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 pancreatic ductal adenocarcinoma 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 pancreatic ductal adenocarcinoma and the adjuvant pancreatic ductal adenocarcinoma 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. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer in Phase 1 studies. In the future, Elicio plans to expand ELI-002 7P to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively.

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Elicio Therapeutics Announces Activation Of Investigator-Initiated Phase 1 Study Of Neoadjuvant ELI-002 7P For Pancreatic Ductal Adenocarcinoma

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