Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week announced that the US Food and Drug Administration (FDA) granted Fast Track Designation to its allogeneic CAR T therapy azer-cel for relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory marginal zone lymphoma (MZL), providing additional momentum for the company's cell therapy program.
Speaking with Proactive, managing director and chief executive officer Leslie Chong said the designation followed ongoing engagement with the FDA and reflected both the unmet medical need in these blood cancer indications and the clinical activity observed to date.
Chong said azer-cel had generated encouraging results in heavily pre-treated patients. In CLL, patients had failed at least three prior lines of therapy before entering the study, while MZL patients recorded an 83% response rate. Responses ranged from partial responses to complete responses, with one patient progressing from a partial response to a complete response after several months on treatment.
According to Chong, the company was particularly encouraged by the durability and depth of responses being observed. She noted that partial responses can already support regulatory approval in some settings, making the conversion of patients to complete responses especially noteworthy.
The regulatory milestone follows Imugene's recent oral presentation at the American Society of Clinical Oncology (ASCO) conference, where the company presented updated azer-cel data. Chong described the reception from the oncology community as highly positive.
Fast Track Designation is designed to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs. The designation provides more frequent communication with the FDA and may allow for rolling review of submissions, as well as potential eligibility for accelerated approval and priority review if future clinical data support those pathways.
Chong said the company had already secured FDA acceptance of its pivotal study design, manufacturing process and dosing regimen, providing a foundation for future development activities.
Looking ahead, key catalysts for Imugene include continued patient enrolment in the Fast Track-designated indications, additional clinical data from ongoing studies and further progress in combination cohorts involving Bruton's tyrosine kinase inhibitors. Future interactions with regulators and potential discussions with pharmaceutical partners may also attract investor attention as the program advances.
Chong said, "This designation really expedited development and review for therapies," while noting that Fast Track status creates a more open framework for engagement with the FDA.
With azer-cel continuing to generate data across multiple blood cancer indications, investors will be watching closely for further clinical and regulatory developments.
Interview highlights
- FDA granted Fast Track Designation to Imugene's azer-cel program in relapsed/refractory CLL/SLL and MZL.
- Azer-cel is an allogeneic CD19-targeting CAR T therapy.
- CLL patients treated had failed at least three prior lines of therapy before receiving azer-cel.
- MZL patients demonstrated an 83% response rate.
- Some patients progressed from partial responses to complete responses over time.
- Imugene presented azer-cel data in an oral presentation at the ASCO conference.
- The FDA had previously accepted the company's pivotal study design, dosing regimen and manufacturing process.
- Fast Track Designation allows more frequent FDA engagement and may support accelerated approval and priority review pathways.
- Imugene continues patient enrolment across key indications.
- The company has also begun evaluating combinations with Bruton's tyrosine kinase inhibitors.
- Management remains focused on data generation, regulatory engagement and potential commercial opportunities.
Proactive: Welcome back to Proactive Investors. I'm your host Kerry Stevenson. Joining me again is Leslie Chong, Managing Director and CEO of Imugene (ASX: IMU). The last time we spoke, the company was heading to the ASCO conference in the US, where Imugene was invited to present a paper. Today, the company has announced FDA Fast Track Designation for azer-cel in CLL and MZL. Leslie, congratulations on ASCO and on this latest regulatory milestone. Can you explain what Fast Track Designation means for Imugene and its shareholders?
Leslie Chong: Imugene has been developing azer-cel since acquiring the program and has advanced it across several blood cancers, particularly lymphomas. CLL behaves similarly to a lymphoma, and patients treated had failed at least three prior lines of therapy. All of those patients responded to treatment. In MZL, patients achieved an 83% response rate, ranging from complete responses to partial responses.
One particularly exciting development was seeing a patient move from a partial response to a complete response after approximately four months. Partial responses can already support FDA approval, so converting those into complete responses is very encouraging.
At ASCO we presented these results during an oral presentation to a full audience, and the response was extremely positive. Meanwhile, we have continued enrolling patients and communicating with the FDA. In November, the FDA accepted our pivotal study design, dosing regimen and manufacturing process, allowing us to proceed into pivotal development.
We submitted Fast Track applications for these indications and were pleased to receive the designation sooner than expected. Fast Track supports expedited development and review, particularly in serious diseases with unmet medical needs, and reflects the strength of the data generated so far.
Proactive: What would be different if the company had not received Fast Track Designation?
Leslie Chong: It could potentially take much longer. The FDA only grants Fast Track when it believes a therapy may address a significant unmet need and has shown sufficient promise. The designation creates a more open and frequent dialogue with the agency, allowing us to engage regularly, seek guidance and potentially move more efficiently toward approval.
Proactive: Does the designation include any funding support?
Leslie Chong: No. The FDA does not fund drug development.
Proactive: Why is this important for shareholders?
Leslie Chong: Fast Track Designation gives us greater access to the FDA and more frequent interactions. It also creates the potential for accelerated approval pathways and priority review. Ultimately, these advantages may help bring a drug to market sooner.
Proactive: What are the next steps?
Leslie Chong: We will continue enrolling patients in these indications. We have also started a cohort combining azer-cel with Bruton's tyrosine kinase inhibitors, which are blockbuster therapies marketed by several major pharmaceutical companies.
We're focused on generating more data and preparing for future discussions with regulators, pharmaceutical companies, investors and other stakeholders. Azer-cel has performed strongly across multiple indications, and we're proud of the impact it may have for patients who need new treatment options.
Proactive: Thank you for the update. Congratulations on the Fast Track Designation.
Leslie Chong: Thank you.