US FDA transfers azer-cel IND application to Imugene

The US Food and Drug Administration (FDA) has transferred an investigational new drug (IND) application for allogeneic CD19 CAR T azer-cel from Precision Biosciences Inc to Imugene (ASX: IMU).

The transfer follows Imugene’s acquisition of a worldwide license for the drug in August, as part of an exclusive agreement with Precision.

Under the terms of the agreement, Imugene will also acquire the lease to a state-of-the-art 3047 square metre manufacturing facility in North Carolina, as well as drug material for the completion of a Phase 1b clinical trial and a team of 50 highly-experienced cell therapy and manufacturing staff.

Clinical study

Imugene managing director Leslie Chong said the IND application allows the company to start a registration-enabling clinical study in 2024 for patients with third and fourth line diffuse large B cell lymphoma and other blood cancer indications.

“We are actively progressing an ongoing multi-centre Phase 1b study of azer-cel as we prepare for the start of a potential Phase 2 registrational study at the earliest opportunity,” she said.

“We expect the US government’s online clinical trials database will soon be updated to reflect Imugene being the sponsor.”

Imugene has licenced Precision’s cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) for use in the treatment of certain blood cancers.

The company also plans to combine the drug with its existing onCAR19 therapies to treat solid tumors.

Allogeneic drug

Azer-cel has been developed as an off-the-shelf (allogeneic) drug, meaning it will be available to the market on-demand and immediately.

It will not require leukapheresis (a lab procedure where white blood cells are separated from a patient’s bloodstream) nor will it need any bridging therapies such as steroids, chemotherapy or radiation.

This compares to the development pathway for traditional cancer drugs which often involves a long and complex manufacturing process and wait time inclusive of leukapheresis and bridging.

onCARlytics platform

Azer-cel is expected to sit well alongside Imugene’s onCARlytics platform.

“By adding azer-cel to the Imugene pipeline, our onCARlytics program will form the foundation of a novel and broadened approach to cell therapy,” Ms Chong said.

“OnCARlytics can enhance the expression of CD19 on solid tumours [while] azer-cel is designed to identify and kill malignant cells expressing the CD19 marker… we are thrilled about the potential benefits of combining these technologies.”