Imugene ASX:IMU says its concurrent BTKi cohort in the Phase 1b azer-cel basket trial has delivered a second complete response within 24 hours.
The latest update centres on azer-cel, formally azercabtagene zapreleucel, in a cohort combining the company’s off-the-shelf CAR T therapy with a Bruton Tyrosine Kinase inhibitor, or BTKi.
The new complete response came from the first treated mantle cell lymphoma (MCL) patient, who had progressed after prior BTKi therapy and reached a complete response at the Day 28 assessment.
That follows Imugene’s announcement the previous day of the first complete response in the same cohort, which involved a follicular lymphoma patient who had also previously failed BTKi treatment.
What the Program Is
Azer-cel is an allogeneic, off-the-shelf CD19-targeting CAR T therapy, which Imugene describes as being designed for administration within days rather than requiring the longer manufacturing lead times associated with autologous, patient-specific CAR T approaches.
Today’s result sits inside Imugene’s broader Phase 1b azer-cel basket trial, which the company has been running across multiple B-cell malignancies.
Recruitment is ongoing across 10 US and five Australian clinical sites, according to the filing.
The specific cohort in focus is the concurrent BTKi cohort, aimed at patients who have relapsed on, or are refractory to, BTKi therapy.
This part of the study is testing whether giving azer-cel concurrently with a BTKi can restore or enhance activity after BTKi progression.
This arm of the study is relatively new.
In a 27 May 2026 update, Imugene said it had dosed the first patient in the BTKi combination cohort at Baylor University in Waco, Texas, initially highlighting mantle cell lymphoma patients who had failed prior BTKi therapy.
The wider azer-cel program also has some regulatory context behind it.
In June 2026, Imugene disclosed FDA Fast Track Designation for azer-cel in relapsed or refractory CLL/SLL and MZL.
In its FY25 annual report, the company also cited a 79% overall response rate in 14 evaluable DLBCL patients, and said pivotal strategy discussions with the FDA were scheduled for Q4 CY25.
Enrolment and Evaluability
The next immediate milestone is further enrolment and evaluability in the concurrent BTKi cohort across the 15 active sites, because the current efficacy signal is based on such a small dataset.
Later follow-up on these Day 28 complete responses, particularly around durability and fuller safety disclosure, should provide a clearer picture of whether the cohort’s early signal is holding up.
In cell therapy programs, early response depth is important, but it is not enough on its own to establish a development path.
Beyond this cohort, the broader azer-cel program still has regulatory steps in view.
Imugene’s annual report said additional Phase 1b data were expected across Q3, Q4 and Q1, with an FDA Type B end-of-phase meeting scheduled for Q4 CY25.
The same report said the company was preparing for a pivotal Phase 2 registrational trial in CY26, subject to data and regulatory approvals.
Early Signal, Still Very Small
Imugene’s latest filing strengthens the early case for the concurrent BTKi azer-cel strategy by extending the Day 28 complete response signal to a second evaluable patient and the first disclosed mantle cell lymphoma case.
But the result is still based on a two-patient evaluable dataset, so the next readouts on durability, safety and additional cohort maturity are likely to matter more than the headline response rate alone.
Funding remains part of the watch list as well.
Imugene’s annual report said it had US$21.9 million in cash at 30 June 2025, alongside post-year-end funding commitments including a US$22.5 million placement and a planned US$15 million share purchase plan.
That leaves a familiar set of risks for a clinical-stage biotech.
Clinical failure or delay, regulatory uncertainty, recruitment pace, execution across multiple trial sites, and future funding needs are all still central to how the azer-cel story develops from here.