Azer-cel FDA IND Transferred to Imugene

On September 27, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that the US Food and Drug Administration (FDA) has transferred the Investigational New Drug (IND) Application for its allogeneic CD19 CAR T azer-cel from Precision Biosciences Inc. (NASDAQ GS: DTIL) to Imugene, following the exclusive worldwide license acquired in August (Press release, Imugene, SEP 28, 2023, View Source [SID1234635467]).

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Imugene MD & CEO, Ms Leslie Chong said, "We are actively progressing the ongoing multi-centre Phase 1b (ClinicalTrials.gov ID NCT03666000) study using the recommended Phase 2 regimen of azer-cel as we prepare for the start of a potential Phase 2 registrational study at the earliest opportunity, and we expect the Clinicaltrials.gov ID will be updated to reflect Imugene being the sponsor imminently."