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Elicio Therapeutics to Test KRAS-Targeted Cancer Vaccine With Regeneron Immunotherapy

NEW YORK – Elicio Therapeutics said Monday that it signed an agreement with Regeneron to supply Libtayo (cemiplimab) for a clinical trial exploring the activity of the immune checkpoint inhibitor with Elicio's KRAS-targeted cancer vaccine ELI-002 in patients with certain types of KRAS-mutated cancers.

In the trial, which is expected to begin in 2023, Elicio will enroll patients with advanced non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

The ELI-002 vaccine combines mutated KRAS peptides with an immune stimulatory oligonucleotide using Elicio’s Amphiphile platform, which targets the vaccine directly to the lymph nodes using albumin as a carrier. There, it trains immune cells to target and attack tumor cells. The Amphiphile technology came from Massachusetts Institute of Technology, where Elicio Cofounder Darrell Irvine and colleagues figured out how to target the drug to the lymphatic system without it escaping into the blood stream.

"We're investigating ELI-002's immune education in combination with the ability of Libtayo to block PD-1 and potentially activate the ELI-002-induced T cells to target cancers," Christopher Haqq, chief medical officer at Elicio, said in a statement, explaining that "the AMP technology allows for ELI-002 to be delivered in high quantities to the lymph nodes and remain there, where it will 'educate' the immune cells to target tumor cells for killing."

Boston-based Elicio is also evaluating ELI-002 in a Phase I trial with a mixture of lipid-conjugated peptide-based antigens (Amph-Peptides) as an adjuvant therapy in patients with KRAS- or NRAS-mutated solid tumors who also test positive for minimal residual disease using an investigational ctDNA test. This formulation of ELI-002 is designed to target the seven most common KRAS mutations.