Imugene Ltd (ASX:IMU, OTC:IUGNF) has achieved the first milestone under its licence agreement with Precision BioSciences and will issue 19,491,635 shares along with a US$3 million cash payment. The milestone was triggered as the company began discussions with the US FDA on a potential pivotal trial for azer-cel — the allogeneic CAR T-cell therapy it licensed from Precision in mid-2023.
“This marks an important milestone for Imugene. We look forward to meeting with the FDA in November to obtain guidance on the optimal design and pathway for a Phase 2/3 clinical trial to advance this exciting technology to patients and clinicians,” Imugene’s CEO, Leslie Chong, said. “The clinical data is highly encouraging, and the recent update on patients who have not previously received CAR T therapy further strengthens our confidence in the program."
Multi-centre Phase 1b study
Azer-cel (azercabtagene zapreleucel) is being evaluated in an ongoing, open-label, multi-centre Phase 1b study in the US and Australia. The trial initially enrolled patients with relapsed diffuse large B-cell lymphoma (DLBCL) following prior CAR T therapy and has since expanded to include CAR T-naïve patients with a broader range of non-Hodgkin lymphoma subtypes, including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), Waldenström macroglobulinaemia (WM) and follicular lymphoma (FL).
Treatment with azer-cel alongside lymphodepletion and IL-2 has shown encouraging clinical activity with durable responses to date, and a manageable safety profile.
“We are impressed with the progress Imugene has made in advancing azer-cel in CAR T relapsed patients with DLBCL, as well as patients who are CAR T naïve,” Precision’s CEO, Michael Amoroso, said.
“The decision to proceed to a meeting with the FDA to discuss a pivotal trial reflects the positive, durable clinical data that has been generated to date. We are following azer-cel’s progress with great interest and anticipation as it adds to the growing clinical dataset supporting the ARCUS platform."
Early signs of efficacy
Last week Imugene reported early signs of efficacy from the CAR T-naïve arm of its ongoing Phase 1b study of azer-cel, an off-the-shelf, allogeneic CD19 CAR T-cell therapy under evaluation across multiple B-cell lymphoma indications.
Read more: Imugene posts 83% response rate in CAR T-naïve lymphoma cohort
Among six patients assessed to date with no prior CAR T therapy, five (83%) achieved an overall response, including three complete responses (50%). Results for an additional treated patient are pending. In total, 10 patients have been dosed in this cohort, which includes several rare and hard-to-treat subtypes — Waldenström macroglobulinemia, marginal zone lymphoma and primary CNS lymphoma — where no CAR T therapies are currently approved.