gengleucel (IGNK001) / Ingenium Therap - LARVOL DELTA

Ingenium Therapeutics Receives FDA Feedback Enabling Direct Phase 2 Trial for Gengleucel in MRD+ AML (PRNewswire) - "Ingenium Therapeutics...announced that it has received positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Pre-Investigational New Drug (Pre-IND) meeting...Ingenium has conducted multiple investigator-initiated trials in South Korea, enrolling over 140 patients with acute myeloid leukemia (AML), including a Phase 2 randomized clinical trial with long-term overall survival follow-up. These studies have generated robust non-clinical and clinical data supporting the safety and efficacy profile of Gengleucel...Based on its review of these data, the FDA has provided positive feedback on Ingenium's proposal to initiate a Phase 2 trial of Gengleucel in the United States without a preceding Phase 1 study. This regulatory milestone may streamline Gengleucel's clinical development pathway and may accelerate access for patients with measurable residual disease-positive (MRD+) AML....The trial is expected to begin in early 2026..."

FDA event • New P2 trial • Acute Myelogenous Leukemia

Ingenium Therapeutics Novel NK Cell Therapy Receives Orphan Drug Designation From FDA (PRNewswire) - "Ingenium Therapeutics...announced today that its investigational therapy IGNK001 (Gengluecel) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML)....'Gengluecel has already received approval from the Korean Ministry of Food and Drug Safety for phase 2 clinical trials, and we are preparing to initiate clinical trials in the U.S. targeting 80 subjects with the goal of completing the studies by December 2027.'"

New P2 trial • Orphan drug • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology