Imugene Ltd (ASX:IMU, OTC:IUGNF) has passed a major milestone for its Azer-cel cell therapy treatment with the dosing of the first patient for its Phase 1b Allogeneic CAR T Clinical Trial.
It follows a Phase 1a trial that included 84 patients across leading US healthcare centres and offered strong safety and efficacy signals according to IMU.
The second part of this Phase 1 trial involves the study of Azer-cel in an ongoing, mult-centre clinical trial in patients with non-Hodgkin’s lymphoma blood cancer, and serves as a precursor to Phase 2 registrational (subject to FDA approval) in 2024.
Under three months from acquisition
“It is a great credit to our team that the Phase 1b study has been initiated and the first patient dosed, in under three months since acquiring the technology,” Imugene CEO and managing director Leslie Chong said.
Azer-cel, or allogeneic off-the-shelf CD19 CAR T, a type of cell therapy, was given to a patient suffering from a difficult to treat sub-set of NHL called Diffuse-Large B-cell lymphoma (DLBCL).
“Patients with DLBCL who have relapsed after autologous CART therapy have limited therapeutic options and are an unmet medical need,” Imugene chief medical officer Dr Paul Woodard said.
“New and effective therapies are needed for these patients.”
The Azer-cel clinical drug supplied for the trial came from Imugene’s state-of-the-art manufacturing facility in North Carolina, which is a registered GMP (Good Manufacturing Process) site.
IMU says the proprietary next generation azer-cel process has evolved into a potential first-in-class cell therapy drug.