Boston, Aug. 10, 2026
Elicio Therapeutics, Inc. announced the activation of an investigator-initiated Phase 1 clinical study evaluating its investigational cancer immunotherapy ELI-002 7P in combination with chemotherapy and anti-PD1 checkpoint inhibition for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC). The multicenter study is being conducted by Memorial Sloan Kettering (MSK) Cancer Center and funded through a strategic partnership between The Lustgarten Foundation and Break Through Cancer. The randomized, open-label study is expected to enroll 20 patients with KRAS-mutant PDAC and will investigate ELI-002 7P in the neoadjuvant setting, meaning treatment will begin before surgery. Patients will receive the investigational immunotherapy alongside standard mFOLFIRINOX chemotherapy, with or without tislelizumab, an anti-PD1 checkpoint inhibitor. The study represents an important clinical development step for Elicio as it evaluates whether its immune-targeting approach can improve treatment outcomes for patients undergoing potentially curative pancreatic cancer surgery.
ELI-002 7P to Be Evaluated Before and After Surgery
The Phase 1 study is designed to investigate the potential of ELI-002 7P across multiple stages of pancreatic cancer treatment, beginning before surgery and continuing afterward. Researchers will evaluate the combination in patients whose tumors are considered resectable or borderline resectable, populations that can undergo surgery but continue to face substantial risks of disease recurrence. During the study, investigators will collect tumor tissue and blood samples to examine immune activation, changes in the tumor microenvironment and potential biomarkers associated with treatment response. Elicio said the trial builds on earlier clinical observations involving sequential treatment with ELI-002 7P followed by checkpoint inhibition and chemotherapy in patients with metastatic PDAC, where complete responses were observed in some patients. The new study will prospectively examine the combination strategy in an earlier disease setting, potentially providing information about whether immune activation before surgery could influence surgical outcomes and longer-term disease control.
Study Targets KRAS-Mutant Pancreatic Cancer
The investigation focuses on KRAS-mutant PDAC, a major molecular subtype of pancreatic cancer in which KRAS mutations act as important drivers of tumor growth. ELI-002 7P is an investigational off-the-shelf cancer immunotherapy designed to stimulate immune responses against seven common KRAS mutations. The therapy uses Elicio’s proprietary AMP technology, which combines AMP-modified mutant KRAS peptide antigens with ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant. The approach is intended to activate and amplify cancer-specific T-cell responses, potentially enabling the immune system to recognize and attack tumor cells carrying KRAS mutations. According to Elicio, the seven-peptide formulation is designed to cover KRAS mutations responsible for approximately 25% of solid tumors, potentially allowing the approach to address a broad patient population. The company previously evaluated ELI-002 7P in the Phase 2 AMPLIFY-7P trial involving patients with KRAS-mutant pancreatic cancer who had completed standard treatment but remained at high risk of relapse.
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Elicio Therapeutics Advances Broader Cancer Immunotherapy Program
The newly activated study expands Elicio Therapeutics’ clinical development strategy for ELI-002 7P while the company continues evaluating its potential in pancreatic and other KRAS-driven cancers. Elicio plans to use findings from the neoadjuvant study to generate translational data, assess immune responses and identify biomarkers that could help guide future clinical development. The company also intends to initiate a separate Phase 1 study in metastatic PDAC designed to rapidly evaluate clinical activity, including objective responses such as partial and complete radiographic responses. ELI-002 has additionally been studied in patients with KRAS-mutant colorectal cancer, while Elicio plans to explore potential applications in KRAS-mutant lung cancer and other cancers. Beyond ELI-002, the company’s pipeline includes ELI-007, an off-the-shelf immunotherapy targeting BRAF-driven cancers, and ELI-008, designed to target p53 hotspot mutations. The activation of the Phase 1 neoadjuvant trial therefore represents a significant step in Elicio’s effort to develop off-the-shelf immunotherapies for high-prevalence cancers, while generating clinical evidence that could shape future combination and Phase 3 development strategies.
Source: Elicio Therapeutics press release
