Imugene gains FDA tick for allogeneic CAR-T manufacturing changes

The US FDA has approved changes in the manufacturing process for azer-cel, an allogeneic (off the shelf) CAR-T recently added to Imugene’s pipeline.

Azercabtagene zapreleucel (azer-cel) is an anti-CD19 allogeneic CAR T candidate being studied in an ongoing multi-centre Phase Ib clinical trial in patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL).

Leslie Chong, CEO of the Australian immuno-oncology company Imugene, said: “Azer-cel has the potential to be the first CD19 directed allogeneic cell therapy and having the FDA support on the manufacturing process that can be used for the pivotal trial is an extremely important milestone for Imugene as it improves the overall robustness and scalability of the product.”

DepositPhotos/grandbrothers

The process has been validated and optimised along the way for 84 patients to date, and the drug product for Phase Ib confirmatory trial has been completed.

“There are several CAR-T on the shelf because they never received FDA clearance on a particular manufacturing batch. […] Our 1.2 batch is the one that we will place into an expansion study and validate that process and hopefully, in 2024, this is the batch we are going to take into a pivotal Phase II study,” said Chong.

The stepping stone for Imugene to bring the product to the market is the GMP facility in Durham, North Carolina, recently leased from Precision Biosciences, from which Imugene acquired the rights to azer-cel.

The 32,800 square-foot plant – of which 17,300 square feet are already dedicated to manufacturing and 15,500 square feet will be available after an expansion – will provide drug material for completion of the Phase I clinical trial and comes with an experienced cell therapy and manufacturing team of around 50 people.

Deal with Precision Biosciences

Imugene paid Precision $21 million upfront in cash and equity for global rights to azer-cel last month. When the therapy completes the Phase Ib trial, Precision is eligible for another $8 million. The company could receive up to $198 million in milestone payments, plus royalties on net sales, if the drug is successful.

“We are very pleased to partner with Imugene as they plan to leverage azer-cel’s clinical data package and recent regulatory feedback to continue its path toward a pivotal trial in LBCL (Large B-Cell Lymphoma) and potentially help patients in dire need. Our commercial and scientific interests are closely aligned, and we believe Precision’s allogeneic CAR-T technology can complement the novel oncology approaches being pursued by Imugene, especially its OnCARlytics platform for solid tumors,” said Michael Amoroso, CEO of Precision.

Imugene also has the option to develop up to three other cancer research programs in the future, each of which is tied to up to $145 million in milestone payments.