Elicio Therapeutics announced that an independent data monitoring committee (IDMC) has recommended continuation of the Phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) following a pre-specified interim review of unblinded safety and efficacy data. The IDMC recommended that the trial continue to final analysis without modifications and confirmed the favorable safety profile of ELI-002 7P to date.
IDMC Decision Signals Preliminary Efficacy
"We are encouraged by the IDMC's recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy," said Robert Connelly, Chief Executive Officer of Elicio. The company views the IDMC's positive recommendation as an indication that ELI-002 7P has demonstrated early signs of therapeutic benefit in this challenging cancer indication.
The final disease-free survival (DFS) analysis is anticipated to occur in the fourth quarter of 2025. Elicio previously reached alignment with the U.S. Food and Drug Administration (FDA) on key elements of the planned pivotal Phase 3 study design and plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study upon completion of the final DFS analysis.
Trial Design and Patient Population
The AMPLIFY-7P trial is a 2:1 randomized, open-label, multicenter clinical trial that enrolled 144 patients at 24 U.S. sites to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to standard of care (observation) to improve DFS in patients with PDAC in the adjuvant setting post local therapy, following surgery, chemotherapy, with or without radiation. Currently, the standard of care in this setting is to conduct serial imaging scans to monitor closely for cancer progression.
ELI-002 7P treatment consists of six doses, followed by an observation period of eight weeks, and followed with four additional booster doses. In the experimental phase 1A portion of the trial, patients received 10.0 mg of ELI-002 Amph-CpG-7909 admixed with 1.4 mg or 4.9 mg of ELI-002 Amph-Peptides 7P via weekly subcutaneous injection for 4 weeks followed by biweekly dosing over the next 4 weeks during the immunization period. After 2 months of no dosing, additional subcutaneous injections were given weekly for 4 weeks during the booster period.
Addressing Significant Unmet Medical Need
PDAC is an aggressive cancer with a five-year survival rate of 13% and is projected to become the second leading cause of cancer death in the U.S. by 2030. ELI-002 7P is an investigational, off-the-shelf, immunotherapy vaccine administered by subcutaneous injection targeting seven KRAS mutations in 88% of PDAC patients and 25% of all solid tumors.
The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002. Off-the-shelf vaccine approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized vaccines approaches.
Amphiphile Platform Technology
ELI-002 7P is built with Elicio's proprietary Amphiphile (AMP) technology, which aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. The AMP platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes.
ELI-002 is comprised of two powerful components that are built with Elicio's AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.
Financial Position and Timeline
The company's current cash runway extends into Q1 2026, past the anticipated final DFS analysis. Elicio remains blinded to the trial clinical efficacy outcomes pending the final analysis expected in Q4 2025.
