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Elicio Therapeutics Carves Out Registrational Path for KRAS Cancer Vaccine

NEW YORK – Elicio Therapeutics earlier this week said it has reached an agreement with the US Food and Drug Administration on a planned Phase III trial and registrational strategy for its KRAS-targeted cancer vaccine ELI-002.

The firm said it received positive feedback from the FDA during an end of Phase I Type B meeting to discuss the design of a Phase III trial for ELI-002 in KRAS-mutant pancreatic cancer, and they settled on an appropriate dose and schedule, the patient population, and the primary endpoint of disease-free survival. If the Phase III trial is positive, Elicio said it would expect to file a biologics license application (BLA) for ELI-002 in this setting.

Boston-based Elicio is studying ELI-002 as an adjuvant treatment for KRAS-mutated pancreatic ductal carcinoma patients in the Phase II AMPLIFY-7P trial. The firm also has an ongoing Phase I/II study of ELI-002 in KRAS-driven pancreatic, colorectal, ovarian, bile duct, gallbladder, and non-small cell lung cancer patients who have circulating tumor DNA after surgery or chemotherapy.

"We believe that ELI-002 could have a transformational role in the management of difficult-to-treat mutant KRAS cancers as an off-the-shelf monotherapy treatment for patients who completed neoadjuvant, perioperative, or adjuvant chemotherapy and yet remain at elevated risk of disease recurrence," Elicio CEO Robert Connelly said in a statement.

Connelly added that the company expects to report interim data in the first half of this year from the AMPLIFY-7P trial in KRAS-mutant pancreatic cancer. "If these results are positive, we intend to rapidly advance the program into a Phase III study, which could potentially support regulatory approval," he said.

Elicio's pipeline also includes two preclinical off-the-shelf therapeutic cancer vaccines: ELI-007 for BRAF-driven cancers and ELI-008 targeting p53 hotspot mutations.