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Elicio Therapeutics Begins Phase I/II Trial of Vaccine Against KRAS-Driven Tumors

NEW YORK – Elicio Therapeutics on Tuesday said it has begun a Phase I/II trial exploring the preliminary activity of a therapeutic vaccine for patients with KRAS-driven tumors who have minimal residual disease after surgery.

ELI-002 is a therapeutic vaccine that joins up with albumin proteins in the blood and travels to lymph nodes to delivers mutated KRAS peptides and a proprietary adjuvant. Using this strategy, Elicio is hoping to train patients' immune system to recognize and attack KRAS-mutated cancer cells.

"Our lymph node-targeted therapeutic vaccine ELI-002 is designed to target all seven common KRAS mutations, including G12C," Christopher Haqq, Elicio's chief medical officer, said in a statement. "We believe that the ability of our proprietary [Amphiphile] platform to deliver ELI-002 directly to the lymph nodes, the control center of the immune system, may stimulate an enhanced immune response."

The newly launched AMPLIFY-201 study is being conducted at multiple US clinical sites, including MD Anderson Cancer Center, Memorial Sloan Kettering, Sarah Cannon Research Institute, Massachusetts General Hospital, City of Hope, Washington University St. Louis, and Henry Ford Health System. Researchers hope to enroll 150 patients with various types of KRAS-mutated cancers, specifically patients with pancreatic ductal adenocarcinomas characterized by RAS mutations and patients with colorectal cancer and other solid tumors driven by KRAS and NRAS mutations.

In the study, patients will also be tested on an investigational in vitro diagnostic that detects ctDNA to determine if they have minimal residual disease before imaging scans pick up signs of relapse. Researchers will follow patients to gauge ELI-002's safety and maximum tolerated dose, as well as their ctDNA change from baseline, relapse-free survival, and immunological responses to the drug. Elicio expects to report initial safety, dose escalation, and correlative biomarker data from the Phase I portion of the trial in the first half of 2022.