FDA backs Imugene's azer-cel treatment plan - ICYMI

Core Insights - Imugene Ltd has received full support from the US FDA for its Phase 1B study data regarding its CAR-T cell therapy, azer-cel, validating the proposed dosing regimen, lymphodepletion schedule, and manufacturing process [1][2] - The FDA's feedback allows the company to proceed with its pivotal study design, confirming the efficacy, safety, and process standards of azer-cel [2][8] - The company reported an 82% overall response rate from its Phase 1B trial, indicating strong potential for the therapy [4][10] FDA Support and Study Progress - The FDA has not requested further data or dosing adjustments, which is considered a rare outcome at this stage of development [2][8] - The CEO emphasized that the FDA's affirmation provides a clear path for the pivotal study, as all aspects of the proposed plan have been approved [8][10] - Imugene is currently dosing its CAR-T naïve cohort, which has no approved CAR-T therapies, representing a rapid opportunity for data generation and regulatory engagement [3][9] Future Plans and Data Collection - The company is actively presenting azer-cel at the ASH conference and plans to continue collecting clinical data while preparing for pivotal manufacturing steps in the upcoming year [3][10] - The strategy includes gathering data in both DLBCL and the CAR-T naïve cohort, aiming for a fast-to-market approach [10]