Imugene Ltd (ASX:IMU, OTC:IUGNF) has opened the first Australian site for its azer-cel (azercabtagene zapreleucel) Phase 1b clinical trial, which expands its allogeneic CAR T-cell therapy program for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The Royal Prince Alfred Hospital in Sydney will spearhead Australian patient recruitment, which begins in November 2024, becoming Australia’s only actively enrolling allogeneic CAR T-cell trial.
Benefit to Australian patients
The initiation of patient recruitment at the Royal Prince Alfred Hospital expands access to the pioneering azer-cel therapy, with the potential to benefit patients in Australia who are in critical need of new therapeutic options.
“We’re proud to be able to bring this trial to Imugene’s home country and provide an opportunity for Australian patients to benefit from this unique technology,” Imugene managing director and CEO Leslie Chong said.
“This is the first of up to five sites we plan to open in Australia, as we seek to speed up enrolment and deliver improved outcomes in this form of blood cancer.”
DLBCL is an aggressive form of non-Hodgkin’s lymphoma, with around 80,500 cases annually and some 30,000 new diagnoses in the United States alone.
Among these patients, the majority who receive treatments, including autologous CAR T-cell therapies targeting the CD19 protein, experience relapse.
Azer-cel would plug this gap by providing an off-the-shelf, allogeneic CAR T-cell option.
This therapy uses donor T-cells rather than requiring cells from the patient, allowing for quicker treatment and expanded accessibility, which is a notable advantage over traditional autologous CAR T therapies that involve complex harvesting and engineering processes.
Data from US shows promise
Imugene recently reported promising results from its US trial sites, where three patients achieved complete responses (CR), including two in Cohort B, who were treated with azer-cel in combination with lymphodepletion chemotherapy and interleukin-2 (IL-2).
These responses have demonstrated durability, with some extending beyond 90 and 120 days, suggesting that azer-cel could offer meaningful benefits for patients with limited treatment options.
For patients in Cohort B, the combination therapy showed ‘clinically meaningful activity and durability’, which increases optimism for a potential breakthrough in DLBCL treatment.
A key step forward
Unlike autologous CAR T-cell therapies that require patients’ own cells, azer-cel leverages donor T-cells, offering a more efficient path to treatment for DLBCL patients.
This off-the-shelf approach has the potential to reduce wait times and eliminate logistical challenges, providing a critical therapeutic option in the high-demand landscape of blood cancer treatment.
Safety data from the ongoing US and Australian trials also reinforced the acceptable safety profile observed in patients treated with azer-cel, including those in Cohort B who received lymphodepletion and IL-2.