Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week confirmed that the US FDA has fully supported the company’s Phase 1B study data for its CAR-T cell therapy, azer-cel. The company said the regulator has validated its proposed dosing regimen, lymphodepletion schedule, and manufacturing process.
Imugene told investors that no further data or dosing adjustments were requested, which it described as a rare outcome for this stage of development. CEO Dr. Leslie Chong said: “We’ve got the absolute dose of how we treat azer-cel approved by the FDA – that’s just gold.”
The company said the FDA’s written feedback provides a green light to proceed with its pivotal study design. It highlighted that the agency endorsed its data across efficacy, safety, and process standards.
The company is now continuing to dose its CAR-T naïve cohort, an indication where there are currently no approved CAR-T therapies. Imugene said this represents a rapid path to data generation and potential regulatory engagement.
Dr. Chong also noted that Azer-cel is currently being presented at ASH, a major hematology conference. The company said it will continue to collect clinical data and begin planning for pivotal manufacturing steps in the new year.
Imugene reported an 82.00% overall response rate from its Phase 1B trial last week.
Proactive:
Welcome back to Proactive Newsroom. I'm now joined by Imugene CEO Dr. Leslie Chong. Leslie, good to have you here on this very bright Monday morning.
Dr. Leslie Chong:
Thank you. Yeah, it’s great indeed.
Proactive:
Leslie, you've now received written minutes from the FDA regarding azer-cel. What has the FDA reported back to you?
Dr. Leslie Chong:
The FDA has confirmed and supported our Phase 1B study data. The lymphodepletion regimen – a conditioning chemo regimen that suppresses T cells to receive azer-cel – has been validated. Sometimes CAR-T companies either dose too aggressively, which can be fatal, or too lightly, which isn’t effective. We’ve got the right combination: the lymphodepletion schedule, azer-cel, and IO2 combo is the correct regimen. Our safety profile looks good. We've now got the absolute dose of how we treat azer-cel approved by the FDA. That’s just gold.
Proactive:
An important point to make here — it’s quite rare for the FDA to not ask for more data and to follow such a smooth process. How much reaffirmation does this give you?
Dr. Leslie Chong:
It’s a complete 100% affirmation. They’re saying they like our formula, dosing, and manufacturing process. Whatever we do for the pivotal study is already set. Most of the time, in these types of meetings, you’d get requests for more data, new dosing comparisons, etc. That can take years. But we’ve received a check mark across everything we submitted. It’s wonderful to see.
Proactive:
Sounds like all the stars are aligned. What does this mean for azer-cel’s upcoming trials?
Dr. Leslie Chong:
The azer-cel team is at ASH — the biggest hematology conference — presenting on azer-cel today, actually. It’s a great day for us. The team did a brilliant job preparing the briefing documents and developing azer-cel with IO2. We’ll keep moving forward. We're continuing to dose our CAR-T naïve cohort, which is an indication with no prior CAR-T experience and no approved therapies. There's a rapid opportunity to gain data and go back to the FDA. We’ll also initiate plans for the pivotal study.
Proactive:
You reported an 82% overall response rate for azer-cel’s Phase 1B trial last week. With the FDA’s feedback now in hand, what can investors expect as we head into the new year?
Dr. Leslie Chong:
Along with FDA support across our dosing, manufacturing, and pivotal study plan in DLBCL, we’ll continue gathering data both in DLBCL and the CAR-T naïve cohort. That’s a fast-to-market strategy. We'll also begin the process for pivotal manufacturing. The team is busier than ever.
Proactive:
Imugene CEO Dr. Leslie Chong, thank you so much for your time.
Dr. Leslie Chong:
Thank you.