Imugenes Azer-cel Achieves Milestone

Imugene Limited (ASX: IMU) has reached a significant milestone with the dosing of the first patient in the Phase 1b clinical trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T cell therapy. The achievement follows a successful Phase 1 trial involving 84 patients at leading US centers. Azer-cel is currently undergoing a multi-center Phase 1b trial in patients with non-Hodgkin’s lymphoma (NHL), serving as a precursor to a Phase 2 registrational study in 2024, subject to FDA agreement.

The Phase 1b trial has shown strong safety and efficacy signals based on the positive outcomes observed in the Phase 1 study. Azer-cel is manufactured and supplied from Imugene's advanced facility in North Carolina. The first patient, treated at Banner Health in Phoenix, Arizona, is diagnosed with Diffuse-Large B-cell lymphoma (DLBCL), a challenging subset of NHL.

Dr. Paul Woodard, Imugene’s Chief Medical Officer, emphasized the critical need for effective therapies for DLBCL patients who have relapsed after autologous CART therapy. The success of the Phase 1b study may pave the way for a registrational study in 2024, aiming to make azer-cel the first approved allogeneic CAR T cell therapy for cancer.

Imugene received positive feedback from the FDA in September 2023 on the azer-cel manufacturing process for the registrational clinical trial. The company's manufacturing facility, utilizing Good Manufacturing Process (GMP), is recognized for its state-of-the-art capabilities. Imugene's CEO, Ms Leslie Chong, commended the team for initiating the Phase 1b study within three months of acquiring the technology.

Azer-cel, beyond its application in blood cancers, holds promise for combining with Imugene’s onCARlytics for treating solid tumors, expanding its potential market share in the broader oncology landscape. Imugene's advancements signify a breakthrough in the development of innovative cell therapies with the potential to address critical unmet medical needs.

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