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FDA throws support behind Imugene cancer drug trial

Updated: Apr 19


Imugene’s laboratory cell and blood studies. Credit: File

Cancer-fighter Imugene says it has received positive feedback from the United States Food and Drug Administration on its proposed trials and commercial manufacture of “Azer-cel” to treat patients with certain blood cancers.


The company says the early imprimatur from the FDA is a significant boost for its ambition to provide the lucrative health industry’s first approved off-the-shelf CAR T-cell cancer therapy. It plans to now test the proposed commercial Azer-cel product in pivotal clinical trials next year.


Imugene is a clinical-stage immuno-oncology company developing a range of new treatments that seek to activate the immune system in cancer patients to identify and eradicate tumours. Azer-cel is aimed at attacking blood cancers where a patient who has been both a donor and a recipient of treated cells has relapsed following previous CAR T-cell therapy.


Azer-cel has the potential to be the first CD19 directed allogeneic cell therapy and having the FDA support on the manufacturing process that can be used for the pivotal trial is an extremely important milestone for Imugene as it improves the overall robustness and scalability of the product. Imugene managing director and chief executive officer Leslie Chong

The CD19 antigen protein the company is targeting is a cancer marker commonly found on the surface of B-cells – a type of white blood cell that plays an important role in clinical oncology and identification of cancer.


T-cells are an important part of the immune system and can hunt down and destroy abnormal cells, including some cancer cells. However, cancer cells can also find ways to evade the immune system, requiring a trigger to retrain a person’s immune system to recognise and attack the cancer cells.


CAR T-cell therapy is designed to train and strengthen the immune system to attack some forms of cancer. It involves collecting a small number of T-cells from the patient’s blood, then re-engineering the cells to carry special structures on their surfaces, which are called chimeric antigen receptors (CARs).


The modified T-cells are then added back into the patient as CAR T-cells, with the overall intent being that the re-engineered T-cells will multiply and attack cancer throughout the body. The company describes Azer-cel as a supercharged T-cell designed to identify and kill malignant cells expressing CD19.


Imugene is currently studying Azer-cel in an ongoing multi-centre phase-1b clinical trial in patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukaemia. It says Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile, including promising results in diffuse large B-cell lymphoma (DLBCL) patients who relapsed following previous CAR T treatment.


DLBCL is an aggressive type of NHL that develops from the B-cells in the lymphatic system that are normally responsible for producing antibodies to fight infectious disease. Management also says it is encouraged by the high overall response rates with molecular remissions in that type of patient.


Based on the phase-1b trials data, it believes Azer-cel has the potential to improve patient outcomes in a growing part of the population.


Imugene proposes manufacturing Azer-cel at its state-of-the-art manufacturing facility in North Carolina, where it believes the improved process will allow for increased robustness, consistency, and scalability.


The company may also combine Azer-cel with its onCARlytics platform to deliver and present CD19 antigen on the surface of cancer cells to promote CD19 CAR T-cell anti-tumour responses against solid tumours in patients once approvals are in place. Current approvals for CAR-T cell therapy are already in place in Australia for B-cell acute lymphoblastic leukaemia, adult DLBCL, mantle cell lymphoma and multiple myeloma.


Imugene is also working on gaining approvals for treatments on solid tumour-type cancers, including the use of the chimeric Vaxinia virus.


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