Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week provided an update on its cell therapy candidate azer-cel, highlighting strong response rates and upcoming regulatory and scientific milestones.
The company said azer-cel achieved an 81% response rate in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had previously failed autologous CAR-T therapy. It added that a newly opened cohort of CAR-T naïve patients, a group with no approved CAR-T options, showed an 83% response rate.
Imugene told investors that the data support potential registration strategies in DLBCL as well as other blood cancers such as marginal zone and primary CNS lymphoma.
It confirmed that a meeting has been scheduled with the US FDA in November to seek guidance on the design and regulatory pathway for a planned Phase 2/3 trial. The company said a detailed briefing document has been submitted in preparation for that discussion.
Imugene also noted that azer-cel will be featured in an oral presentation at the 67th American Society of Hematology Annual Meeting in December. The company said oral presentations are peer-reviewed and reserved for data considered highly significant.
It highlighted that enrolment in the CAR-T naïve cohort had increased fourfold, which it said demonstrates growing confidence from clinicians in the azer-cel programme.
Proactive: Phase 1B trial of azer-cel has returned a pretty impressive response rate. The full rundown is with Imugene CEO Leslie Chong. Leslie, it's good to see you again. How are you?
Leslie Chong: I'm good. I'm doing great. How are you?
Proactive: I'm very good. Leslie, it's always good to see you. You've been the bearer of good news the past few months, but we haven't caught up in about 3 or 4 weeks. I know you've been immensely busy behind the scenes. There's a fair bit to go through this morning. Let's start off with Phase 1b. That's topped the headlines in the past couple of weeks. We know at least five of the first six patients that went through this evaluation responded to the treatment, in a pretty positive way. To put it into simple terms, how promising is this, and how should investors view those results?
Leslie Chong: I'm incredibly excited about the news. Let me distinguish between our initial Phase 1b results, which showed an 81% response rate in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), with patients who had failed autologous CAR-T. That's the key point—DLBCL, CAR-T failure. Now we've opened a cohort of CAR-T naïve patients—those who have never had CAR-T. This is a niche area with no approved CAR-T therapy. To see an 83% response rate in this population is significant. It gives us an opportunity to go into approval or registration studies more easily because there’s no approved CAR-T. It also shows azer-cel’s strength in other blood cancers like marginal zone and primary CNS lymphoma. So it's not just DLBCL anymore—it’s multiple indications. I'm excited about how well azer-cel is performing across these populations.
Proactive: All of that is building towards some major milestones. You're set to meet with the FDA in November. That’s huge—guidance on the design and pathway for Phase 2/3. What are you expecting out of the meeting?
Leslie Chong: You're absolutely right. Getting a meeting with the FDA to discuss pivotal study design is a major step. The FDA doesn't always accept meetings. The fact that we secured one means a lot. We've prepared a strong briefing document focused on relapsed/refractory autologous CAR-T failed patients in DLBCL. This meeting also allows us to talk about our CAR-T naïve population and various design options. We welcome this meeting—it will help us gain perspective and a unique design path for azer-cel.
Proactive: It's a busy couple of months. You’re off to Orlando to present at the 67th American Society of Hematology (ASH) Annual Meeting in December. That’s the world's premier hematology event. You’ve been given the chance to speak publicly to investors and participants, which not many companies do at this stage. What should investors look forward to now that azer-cel is getting more exposure?
Leslie Chong: You're right. Getting an oral presentation is rare and peer-reviewed. That means other hematologists reviewed and selected our data. It’s the biggest hematology conference in the world. We get to spotlight azer-cel and highlight its strong performance—not just to pharmaceutical companies but also to hematologists and investors. Enrollment in our CAR-T naïve cohort has gone up four times the previous rate. That tells us that clinicians are voting with their feet—they're putting patients into our study and trusting us. To get 83% in that group and 81% in DLBCL is huge. I'm really looking forward to presenting the data and speaking with everyone there.
Proactive: So many building blocks over the last month—FDA meeting, ASH in December, and Phase 1b progress with azer-cel. Lots to look forward to. We’ll look forward to having you back to discuss the milestones.
Leslie Chong: Thank you so much for having me.