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Elicio Therapeutics Begins Phase II Cancer Vaccine Trial in KRAS-Mutant Pancreatic Cancer

NEW YORK – Elicio Therapeutics on Thursday began treating patients with KRAS-mutant pancreatic ductal carcinoma in the Phase II portion of the AMPLIFY-7P trial in which it is testing the cancer vaccine ELI-002 7P as an adjuvant treatment.

AMPLIFY-7P is a Phase I/II trial, and in Phase I, researchers enrolled patients with KRAS and NRAS mutated solid tumors who were ctDNA positive to measure the reduction or clearance of ctDNA from ELI-002 7P treatment. In Phase II, researchers will randomize 135 KRAS-mutated pancreatic ductal carcinoma patients to either ELI-002 plus a mixture of lipid-conjugated peptide-based antigens (Amph-Peptides 7P) or observation. The first patient to receive treatment within the Phase II portion was enrolled at Northwell Health Cancer Institute's Feinstein Institutes for Medical Research in New York.

ELI-002 is designed to treat cancers driven by seven common mutations in KRAS: G12D, G12R, G12V, G12A, G12C, G12S, and G13D. These seven mutations occur in 25 percent of solid tumors and 88 percent of pancreatic ductal carcinomas.

"Approximately 90 percent of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1 percent, amenable to small molecule treatment," Christopher Haqq, Elicio's chief medical officer, said in a statement. "ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations."

Boston-based Elicio has two other cancer vaccines in preclinical development: ELI-007, which targets BRAF, and ELI-008, which targets p53. In June, Elicio merged with Angion Biomedica to support development of ELI-002 and its other cancer vaccines.