Highlights

  • Imugene dosed the first patient in the BTK inhibitor combination cohort of its Phase 1b azer-cel study.
  • The patient enrolled has mantle cell lymphoma and had previously failed BTKi therapy.
  • The study is evaluating azer-cel in combination with Bruton Tyrosine Kinase inhibitors.
  • Imugene said the approach may improve treatment activity across several B-cell malignancies.
  • The global BTKi market reached approximately US$12 billion in 2025.
  • The ongoing Phase 1b study is being conducted across 10 US sites and five Australian sites

Imugene Limited (ASX:IMU) shares edged higher during morning trade on 28 May 2026 after the clinical-stage immuno-oncology company announced the first patient had been dosed in the Bruton Tyrosine Kinase inhibitor (BTKi) combination cohort of its ongoing Phase 1b azer-cel study.

The stock traded at AUD 0.11, up 1.82% for the session. Despite today’s gain, Imugene shares remain down approximately 79.26% over the past year as investors continue monitoring the company’s clinical progress and broader development strategy across its oncology pipeline.

The latest update centres on the expansion of Imugene’s azer-cel program into combination therapy treatment for patients with advanced blood cancers who have previously failed BTKi therapy.

First Patient Dosed in New Combination Cohort

Imugene confirmed that the first patient enrolled in the newly expanded cohort is being treated at Baylor University in Texas, one of the participating sites in the Phase 1b study.

The patient has mantle cell lymphoma (MCL), a type of B-cell malignancy, and had previously failed treatment with a BTK inhibitor.

The new cohort is designed to evaluate azer-cel in combination with BTKi therapy, with the study assessing both safety and preliminary efficacy outcomes.

According to the company, this represents the third cohort within the broader azer-cel Phase 1b trial program.

The study expansion reflects Imugene’s efforts to explore whether concurrent dosing of azer-cel and BTKi therapies may improve treatment activity in patients with difficult-to-treat blood cancers.

Management noted that resistance or intolerance to BTKi therapy remains a significant challenge despite BTKi drugs becoming established standards of care across several B-cell malignancies.

Why the Combination Approach Matters

The combination strategy targets patients who have limited treatment Options after failing earlier BTKi therapies.

Bruton Tyrosine Kinase inhibitors are widely used in cancers such as follicular lymphoma, chronic lymphocytic leukemia and mantle cell lymphoma. However, many patients eventually experience disease progression or treatment intolerance over time.

Imugene believes combining azer-cel with BTKi therapy could potentially improve treatment effectiveness in these patient populations.

The company’s lead therapy candidate, azer-cel, is an allogeneic CAR T cell therapy designed as an “off-the-shelf” treatment targeting CD19-positive blood cancers.

Unlike autologous CAR T therapies that rely on collecting and modifying a patient’s own cells, allogeneic CAR T approaches are intended to provide a more scalable and readily available treatment option.

The company stated that the BTKi combination cohort broadens the clinical scope of the azer-cel program and may also support future collaboration or partnering opportunities.

Investors appeared to respond favourably to the continued expansion of the company’s clinical strategy, particularly given the size of the BTKi market and ongoing interest in next-generation CAR T therapies.

Global BTKi Market Remains Significant

Imugene highlighted that the global BTKi market reached approximately US$12 billion in 2025, underlining the commercial relevance of therapies targeting this treatment area.

BTK inhibitors have become widely adopted across multiple blood cancer indications, creating a sizeable patient population where resistance or relapse remains an ongoing medical challenge.

By expanding into BTKi-relapsed patient populations, Imugene is attempting to position azer-cel within a clinically important and commercially relevant segment of the oncology market.

The company also suggested that broadening the range of B-cell malignancies included in the Phase 1b study may help prioritise indications where azer-cel demonstrates the most favourable clinical potential.

Management described the strategy as part of a disciplined and Capital-efficient approach to development planning.

About the Azer-Cel Phase 1b Study

The ongoing azer-cel trial is a multi-centre, open-label Phase 1b study being conducted across 10 sites in the United States and five sites in Australia.

The study includes both CAR T-relapsed patients and CAR T-naïve patients diagnosed with several forms of Non-Hodgkin’s lymphoma.

Eligible conditions include follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and mantle cell lymphoma (MCL).

The recently added BTKi combination cohort focuses specifically on patients who have previously failed BTKi treatment.

Imugene stated that treatment involving azer-cel, lymphodepletion and IL-2 has so far demonstrated promising clinical activity and durability of response.

The company also indicated that the therapy’s safety profile has been manageable and generally well tolerated during ongoing evaluation.

Further updates are expected as more patients become evaluable and additional data matures over time.

CEO Highlights Expansion of Clinical Scope

Imugene Chief Executive Officer Leslie Chong described the enrolment milestone as an important step in expanding the company’s clinical development program.

According to Chong, patients who relapse following BTKi therapy represent a sizeable group with limited treatment alternatives.

Management believes the combination strategy could potentially address unmet medical needs within this patient population while simultaneously strengthening the broader evidence base for azer-cel across B-cell malignancies.

The company also noted that ongoing data generation may support future development and commercial discussions.

Understanding Imugene’s Broader Strategy

Imugene is focused on developing cell therapies targeting cancer, with a particular emphasis on allogeneic CAR T treatments for blood cancers.

The company’s lead program, azer-cel, targets the CD19 protein commonly expressed in several B-cell malignancies.

Imugene’s broader vision centres on developing therapies that may improve treatment outcomes for patients with cancers where current therapies remain limited or where relapse rates continue to present clinical challenges.

The company operates within the rapidly evolving CAR T therapy market, where biotechnology firms are increasingly exploring approaches aimed at improving accessibility, Manufacturing efficiency and treatment durability.

Allogeneic or “off-the-shelf” therapies such as azer-cel are viewed by some developers as a potential pathway toward more scalable treatment delivery compared with personalised autologous CAR T approaches.

Why Investors Reacted Positively

Today’s market reaction appeared linked to the continued progression of Imugene’s clinical development pipeline.

Although the update did not contain efficacy data, investors often view patient dosing milestones as important indicators that clinical programs are advancing according to planned timelines.

The initiation of the BTKi combination cohort also expands the company’s addressable patient population and potentially increases future development optionality.

In addition, the reference to the sizeable global BTKi market may have reinforced investor focus on the broader commercial relevance of therapies targeting BTKi-relapsed cancers.

However, as with many clinical-stage biotechnology companies, future investor sentiment is likely to remain heavily influenced by upcoming clinical data, safety outcomes and evidence of treatment efficacy.

What Investors May Watch Next

Following the first patient dosing milestone, market attention is likely to shift toward future safety and preliminary efficacy updates from the BTKi combination cohort.

Investors may also monitor enrolment progress across the ongoing Phase 1b study and any indications where azer-cel demonstrates the most favourable clinical activity.

Potential Partnership discussions, additional trial expansions and updated response durability data may also remain key areas of interest over the coming months.

As the program advances, the company’s ability to generate clinically meaningful outcomes across multiple blood cancer settings may continue shaping sentiment around Imugene’s broader CAR T strategy.