FDA feedback provided on potential ELI-002 Ph 3 study design, including dose, schedule, patient population and primary endpoint analysis
Robert Connelly, Chief Executive Officer of Elicio, commented, “We believe that ELI-002 could have a transformational role in the management of difficult-to-treat mKRAS 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. The continued development of ELI-002 is supported by encouraging clinical results that have demonstrated a favorable safety profile, a strong correlation between T cell response, tumor biomarker reductions and reduced risk of recurrence or death. Our ongoing Phase 2 AMPLIFY-7P study, which is fully enrolled, remains on track for a pre-planned interim data analysis in H1 2025. If these results are positive, we intend to rapidly advance the program into a Phase 3 study, which could potentially support regulatory approval.”
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