Elicio Therapeutics, a cancer-focused biotechnology company, has dosed the first patient in randomised Phase 2 AMPLIFY-7P trial of ELI-002 7P as an adjuvant monotherapy in KRAS mutated pancreatic ductal adenocarcinoma (PDAC).

ELI-002 is a structurally investigational therapeutic immunotherapy. It is designed to target mutant KRAS-driven cancers.

The cancer vaccine has been developed using Elicio’s lymph node targeting Amphiphile (AMP) technology.

AMP treats cancers driven by seven common mutations in KRAS present in 25% of all solid tumour cancers and 88% of PDAC patients.

ELI-002 2P is now being examined in Phase 1 AMPLIFY-201 trial in patients with high relapse risk mKRAS-driven solid tumours, following surgery and chemotherapy.

AMPLIFY-7P, a Phase 2 trial, is presently investigating the 7-peptide (7P) formulation of ELI-002 in patients with mKRAS-driven solid tumours that have a high risk of relapse.

The ELI-002 7P formulation aims to expand the pool of viable patients and lower the likelihood of bypass resistance mechanisms by offering immune response coverage against seven of the most prevalent KRAS mutations.

Elicio executive vice president and research and development head Christopher Haqq said: “Approximately 90% of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1%, amenable to small molecule treatment.

“ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations.

“The Phase 2 study builds on positive findings from our 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating a significantly improved decrease in tumour biomarkers, along with strong T cell responses that correlated with a reduced risk of relapse and death.

“We anticipate results from this study will yield definitive data to support clinical efficacy assessment.”

Elicio is scheduled to deliver a Trial in Progress poster regarding the AMPLIFY-7P trial design at the ASCO Gastrointestinal Cancers Symposium in San Francisco, California on 18-20 January.

In the first part of 2024, preliminary intermediate data from the Phase 1A arm of ELI-002 7P monotherapy will be released.