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Highlights
- Imugene is acquiring a license to azer-cel allogeneic CD19 CAR T cell therapy program.
- Azer-cel has the potential to become the first approved allo CAR T cell therapy for cancer.
- onCARlytics program and azer-cel complement each other.
- Imugene to lease a GMP manufacturing facility to complete clinical trials.
Imugene Limited (ASX: IMU) has inked an agreement with Precision Biosciences, Inc., based in North Carolina in the US, for an exclusive licence to the latter’s azer-cel (azercabtagene zapreleucel) allogeneic CD19 CAR T cell therapy program.
Azer-cell reported encouraging results in the ongoing multi-centre Phase 1b clinical trial (patients with non-Hodgkin’s lymphoma (NHL) and acute B-cell lymphoblastic leukaemia (B-ALL)). The results indicated clinically meaningful activity with an acceptable safety profile. Also, it was found that the therapy was especially strong in DLBCL (Diffuse Large B Cell Lymphoma) patients who relapsed after CAR T therapy.
The company also highlighted that azer-cel complements its onCARlytics platform.
IMU believes that there is the potential to begin a registrational study in 2024 in patients with 3rd and 4th line DLBCL. With this development, azer-cel is expected to become the first FDA-approved allogeneic CAR T therapy for blood cancers.
Azer-cel demonstrated significant results across different trials
Currently, the therapy is under a multi-centre Phase 1b clinical trial. As discussed above, in this trial, azer-cel delivered substantial results, especially in DLBCL patients who had relapsed after auto CAR T therapy.
The data set indicated an overall response rate of 83%, a complete response rate of 61%, with 55% durable response more than or equal to six months in this auto CAR T relapse setting.
The update suggested that 60-70% of patients treated with auto CD19 CAR T cell therapy such as Kymriah®, Yescarta® or Breyanzi® will have cancer recurrence or progression.
Azer-cel reported a positive response rate along with an acceptable safety profile in the broader group of patients with relapsed NHL.
Azer-cel also indicated positive results in DLBCL patients who relapsed after CAR T, and the response rate with molecular remissions in this setting was positive. IMU said that considering this dataset, azer-cel can improve outcomes in the growing and large population with unmet needs.
Data source: Company update
In June 2023, a meeting was held with the FDA to get guidance for entering a phase 2 registration study. IMU said that the intended commercial azer-cel product will be evaluated in the clinic and will be used in the potential registrational clinical trial.
Consideration for acquiring right from Precision
As per the licence agreement, Imugene has agreed to pay Precision Biosciences-
Data source: Company update
The company will fund the transaction through existing cash reserves and can partially pay through its equity if it elects to do so. Moreover, IMU will pay US$3 million as an introduction fee to Chimeric Therapeutics Limited in relation to the acquisition.
Advancing Phase 1b clinical trial
Imugene will lease a state-of-the-art 32,800 sq feet GMP manufacturing facility in North Carolina to finalise a phase 1b and phase 2 registrational clinical trial.
IMU’s shares last traded at AU$0.094 apiece on 15 August 2023 with a market cap of AU$603.76 million.