Elicio Therapeutics has initiated the Phase II AMPLIFY-7P clinical trial of its investigational therapeutic cancer vaccine, ELI-002 7P, designed to treat Kirsten Rat Sarcoma (KRAS)-mutated PDAC.

The first patient in the trial was dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research in New York, US.

The trial will enrol 135 subjects with PDAC. They will be randomised into a 2:1 ratio for the ELI-002 7P vaccine or undergo observation.

During the immunisation and booster periods, those in the treatment group will receive subcutaneous injectable doses of ELI-002 7P.

The study aims to further evaluate the antitumor activity of the vaccine.

ELI-002 7P is an adjuvant monotherapy developed using the lymph node-targeting Amphiphile (AMP) technology of Elicio.

The vaccine is designed to treat cancers driven by seven common mutations in KRAS, which are seen in 25% of all solid tumour cancers as well as 88% of PDAC patients.

ELI-002 includes AMP-adapted mutant KRAS peptide antigens and ELI-004.

An AMP-modified immune-stimulatory oligonucleotide CpG adjuvant, ELI-004 is offered as an off-the-shelf subcutaneous injection.

The AMP mKRAS peptides and AMP CpG are specifically directed at the lymph node, where they can bolster crucial immune cells’ action.

This approach contrasts with other KRAS-targeted drugs currently in development, which target fewer mutations.

Elicio research and development head, executive vice-president and chief medical officer 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.  

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