Imugene doses first patient in US trial of Azer-cel allogeneic CAR T therapy

Sydney-headquartered clinical stage immuno-oncology company Imugene (ASX: IMU) has achieved an early milestone with the dosing in the US of the first patient using its recently acquired Azer-cel blood cell therapy.

Earlier this year, Imugene reached an agreement with US-based Precision Biosciences to acquire the global exclusive license to the Azer-cel allogeneic CD19 CAR T cell therapy program.

Azer-cel is an off-the-shelf CD19 CAR T, a type of cell therapy which is being manufactured and supplied from Imugene’s state-of-the-art facility in North Carolina.

The dosing of the first patient in the Phase 1b clinical trial follows a successful Phase 1 trial which involved 84 patients at leading US centres.

Confirmation received

Azer-cel had previously demonstrated clinically-meaningful activity with an acceptable safety profile for patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL).

Notably, the Azer-cel data were found to be especially strong in patients with diffuse large B cell lymphoma (DLBCL) who had relapsed following auto CAR T therapy.

Azer-cel achieved an 83% overall response rate, a 61% complete response rate with 55% durable response greater than or equal to six months in this difficult to treat auto CAR T relapse setting.

Imugene’s chief medical officer Dr. Paul Woodard said the initial Phase 1b patient dosed at Banner Health in Phoenix, Arizona, suffers from DLBCL, a difficult to treat sub-set of NHL.

“Patients with DLBCL who have relapsed after autologous CAR T therapy have limited therapeutic options and are an unmet medical need. New and effective therapies are needed for these patients.”

On a development path

Since that early success, Imugene has progressed through a number of approval processes in the lead-up to the commencement of the current Phase 1b clinical trial.

Dr. Woodard said the commencement of the Phase 1b trial has placed the company on a development path focused on conducting a registrational study in 2024, which would see the company well-placed to move forward with the first approved allogeneic CAR T cell therapy for cancer.

Ongoing multi-centre study

Imugene managing director and chief executive officer Leslie Chong said the Phase 1b allogeneic CAR T study is an ongoing multi-centre Phase 1b clinical trial in patients with NHL and ALL.

“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.”

“Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile, including promising results in DLBCL patients who relapsed following CAR T.”

Beyond using Azer-cel in blood cancers, Imugene plans to combine the therapy with its own treatment of patients with solid tumours, opening a potentially large market for Azer-cel in the 90% of oncology not beyond blood cancers.

FDA thumbs up

In September 2023, Imugene received positive feedback from the US Food and Drug Administration (FDA) on the Azer-cel manufacturing process to be used in the registrational (to-market) clinical trial, and potentially for the manufacturing of the commercial drug product.

The Phase 1b trial and further development of Azer-cel are backed by a $65 million capital raising launched by Imugene in August after it inked the agreement with Precision Biosciences to acquire the global exclusive license for the therapy.

A costly, complex treatment

The Leukemia Foundation reports that by 2035, blood cancer will cost the Australian economy $71.9 billion each year.

Treatment for blood cancer is often long and complex and can result in people and their carers needing to stop working for a long time – or altogether.

Some types of blood cancer remain among the most expensive cancers to treat.

Research published in 2022 found myeloma is the most expensive cancer to treat, and leukemia the third, due to high hospitalisation and pharmaceutical costs.

A third of people with blood cancer face $10,000 in out-of-pocket expenses, while almost one in three people with blood cancer haven’t been able to return to work since their diagnosis.