Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) is drawing fresh attention to its experimental cancer therapy azer-cel after a Channel 10 news report highlighted a patient who entered remission following treatment in the company’s clinical trial.
The report followed Central Coast mother Judy Proctor, who had spent nearly a decade battling aggressive blood cancer and had exhausted standard treatment options before enrolling in the trial. Doctors involved in her care said that without another option she may have had only weeks to live.
After receiving the therapy, Proctor entered remission and was able to undergo a stem cell transplant she had previously been unable to receive — an outcome clinicians described as particularly significant for patients with advanced disease who have relapsed after multiple lines of treatment.
The case offers a human perspective on the science behind azer-cel, an immunotherapy Imugene believes could expand treatment options for patients with difficult-to-treat blood cancers.
Off-the-shelf CAR-T therapy
Azer-cel is an allogeneic CAR-T therapy, a form of immunotherapy that uses genetically engineered immune cells to recognise and destroy cancer cells.
Traditional CAR-T treatments are typically manufactured individually from a patient’s own immune cells, a process that can take several weeks and may not be suitable for patients whose disease is progressing rapidly.
Imugene’s therapy instead uses donor-derived T cells that are engineered in advance, allowing them to be stored and delivered when needed — an approach designed to make treatment faster and more accessible.
During a recent interview on the Fear and Greed Podcast, Imugene chief executive and managing director Leslie Chong said the therapy has already shown encouraging activity in patients with very advanced disease.
“The thing we know about cancer is that every time you fall off of a therapy, it just gets harder and harder, and the cancer gets, unfortunately, very clever in finding an escape route,” Chong said.
She noted that the azer-cel trial is showing complete clearance of cancer for some patients, with others experiencing partial response, where the cancer burden is reduced by at least 50%.
“We know that this is working in a certain population, especially in late stage,” she said.
Early trial results show promising responses
Azer-cel is currently being evaluated in a global Phase 1/1b clinical trial enrolling patients across multiple sites in the United States and Australia.
Earlier clinical data from the study — which Imugene chief medical officer Dr John Byon presented last week at the TD Cowen Health Care Conference in Boston — showed strong response rates in patients with aggressive B-cell lymphomas whose disease had relapsed after previous treatments.
Imugene on Tuesday also reported encouraging new results in additional lymphoma subtypes within the trial’s CAR-T-naïve cohort.
The company recorded a 100% overall response rate in chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL) and an 80% response rate in marginal zone lymphoma, including several complete responses, among patients who had already received multiple prior lines of therapy.
“We are encouraged to see activity emerging across multiple lymphoma subtypes within the CAR-T-naïve cohort, which highlights the potential breadth of azer-cel in areas of significant unmet medical need,” Chong said.
The Phase 1b trial is structured as a multi-indication basket study, allowing researchers to evaluate the therapy across a range of B-cell malignancies and prioritise the indications showing the strongest clinical activity.
Moving toward later-stage trials
The company is now working towards later-stage studies after engaging with the US Food and Drug Administration on the therapy’s development strategy.
Imugene has received regulatory feedback supporting a potential registrational study pathway, which could form the basis for future approval if the therapy continues to demonstrate strong clinical results.
“We’re at that really great spot where we’re at Phase 1b — so, far-progressed Phase 1 — and we’ve already gone to the FDA to get our strategy approved… for a registrational study,” Chong said.
The company is also expanding research into additional rare and niche indications, which could support faster regulatory pathways if results continue to show meaningful activity.
Expanding the program
Beyond the main trial cohorts, Imugene is also exploring combinations of azer-cel with BTK inhibitors, a class of targeted therapies widely used in the treatment of several B-cell cancers.
The combination strategy aims to expand the therapy’s clinical scope and potentially improve outcomes for patients whose disease has progressed after existing treatments.
Further data from the study are expected as patient enrolment continues across clinical sites in Australia and the United States.
For patients like Proctor, the research represents more than just promising clinical data.
After years of treatment and being told there were no remaining options, her latest scans show no evidence of disease — a result that underscores the hope new immunotherapies may offer for patients facing some of the most challenging forms of cancer.
