Imugene Limited (ASX:IMU) has entered into an agreement with US-based Precision Biosciences, Inc. to acquire a worldwide exclusive license to Precision’s azer-cel allogeneic CD19 CAR T cell therapy programme.
Imugene MD and CEO, Leslie Chong said azer-cel has one of the most extensive clinical data sets for a CD19 directed allogeneic cell therapy, a fast-to-market development strategy and a potential registration-enabling clinical trial in 2024 for patients with 3rd and 4th line DLBCL.
“We plan to complete the ongoing multi-centre Phase 1b (ClinicalTrials.gov ID NCT03666000) study using the recommended Phase 2 regimen as we prepare for the start of a potential registrational study at the earliest opportunity. We are very excited as azer-cel has the potential to be the first approved allo CAR T.
“By adding azer-cel to the Imugene pipeline, our onCARlytics program will form the foundation of a novel and broadened approach to cell therapy. CD19 is a well validated clinical target in blood cancers.
“OnCARlytics can enhance the expression of CD19 on solid tumours. Azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19. We are thrilled about the potential benefit for patients from the combination of these two technologies.”
In an ongoing multi-centre Phase 1b clinical trial that includes 84 patients with non- Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL), azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile.
Notably, the azer-cel data were especially strong in patients with DLBCL who had relapsed following auto CAR T therapy. Azer-cel achieved 83% Overall Response Rate (ORR), 61% Complete Response (CR) Rate with 55% durable response greater than or equal to six months in this difficult to treat auto CAR T relapse setting (n=18). It is estimated that 60-70% of patients treated with an approved auto CD19 CAR T cell therapy such as Kymriah, Yescarta or Breyanzi will unfortunately have cancer progression or recurrence.
In the broader group of patients with relapsed/refractory NHL, irrespective of prior treatment with auto CAR T cell therapy, azer-cel showed encouraging response rates and an acceptable safety profile with a 58% ORR and 41% CR rate across all doses and lymphodepletion (chemotherapy) regimens.