The study evaluated ELI-002 in patients with high relapse risk pancreatic and colorectal cancer. Credit: National Cancer Institute on Unsplash.

Elicio Therapeutics has reported positive interim clinical data from its ongoing Phase I AMPLIFY-201 study evaluating its cancer immunotherapy, ELI-002, in patients with high relapse risk pancreatic and colorectal cancer.

The multicentre study evaluated ELI-002 as a monotherapy in patients with mutant KRAS-driven tumours who are at high risk for relapse due to minimal residual disease detection after standard surgery and chemotherapy.

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Five cohorts of patients received a 1.4 mg fixed dose of the two mutant KRAS peptide antigens including Amph-mKRAS G12D and Amph-mKRAS G12R and 0.1mg, 0.5mg, 2.5mg, 5mg or 10.0mg doses of AMP TLR-9 agonistic DNA adjuvant, Amph-CpG-7909.

ELI-002 2P was found to be well-tolerated with no dose-limiting toxicity or cytokine release syndrome observed across five cohorts.

Responses were observed at all dose levels, with an increased proportion of patients having tumour biomarker reduction including a subset with clearance.

Notable mKRAS-specific T cell responses were induced in 87% of patients with an average of a 56-fold increase directly ex vivo.

The recommended Phase II dose (RP2D) is Amph-CpG-7909 10mg.

Elicio executive vice-president, research and development head and chief medical officer Christopher Haqq said: “ELI-002 is designed with our proprietary AMP technology, which allows for smart delivery to the lymph nodes, the ‘brain centre’ of the immune system.

“The immune responses observed were robust and durable in addition to being able to carry out multiple anti-tumour functions.

“These data validate the clinical activity of ELI-002 with two peptides and support our bridge to the seven-peptide formulation of ELI-002, designed to stimulate an immune response against the seven most common KRAS mutations present in 25% of solid cancer patients.”