Imugene CEO Leslie Chong talked with Proactive about the company’s recent receipt of FDA written minutes concerning its phase 1b study of azer-cel.
The FDA confirmed support for Imugene’s conditioning chemotherapy regimen and dosing approach, a key milestone for the azer-cel program. Chong explained that the regulatory body has approved the exact dose and combination regimen used in their trials, saying, “We've got the absolute dose of how we treat azer-cel, approved by the FDA. So that's… gold.”
She noted that the FDA's response was exceptionally positive and unusual in its lack of additional data requests. “Whatever you're doing, we like the formula and your dosing as well as your manufacturing process,” she said. This affirmation clears the path for Imugene to move forward confidently with its pivotal study, with no changes requested to dosing or manufacturing plans.
Chong also shared that the azer-cel team is currently presenting at the ASH hematology conference, and that further dosing of the CAR-T naïve cohort is underway. The company is targeting patients with no prior CAR-T treatment, where no therapies are currently approved.
The company recently reported an 82% overall response rate in its phase 1b trial for azer-cel, and the FDA’s feedback provides added confidence as Imugene prepares for its next regulatory steps.
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