- Imugene (ASX:IMU) reaches a major milestone in its phase 1b clinical trial using azer-cel, dosing its first patient after a successful flagship program in America
- It’s hoped the phase 1b trial will lead to a registrational trial in 2024, subject to US FDA approval
- Following the completion of the phase 1b study, Imugene could become the only company to be approved to offer the first allogeneic CAR T cell therapy for cancer
- So far, all 84 patients to date, who have tested the drug, experience strong safety efficacy, and tolerability of the drug.
- IMU shares are up 18.2 per cent, trading at 13 cents at 11:45 am AEDT
Imugene (ASX:IMU) has reached a milestone in its phase 1b clinical trial using a cell therapy drug, azer-cel, dosing its first patient after a successful flagship program in America.
It’s hoped the phase 1b trial will lead to a registrational trial in 2024, subject to US Food and Drug Administration (FDA) approval.
Azer-cel is being used in immunotherapy studies for patients with a blood cancer called non-Hodgkin’s lymphoma (NHL), however, the latest patient dosed is suffering from a subset 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, new and effective therapies are needed for these patients,” IMU Chief Medical Officer Dr Paul Woodard said.
Following the completion of the Phase 1b study, Imugene could become the only company to be approved to offer the first allogeneic CAR T cell therapy for cancer.
So far, all 84 patients to date, who have tested the drug, have experienced strong safety efficacy, and tolerability of the drug.
IMU shares were up 18.2 per cent, trading at 13 cents at 11:45 am AEDT.