drugset / Press release

New Complete Response in the Concurrent BTKi azer-cel Cohort

2026-07-01 · Imugene Limited · original weblink.com.au ↗

IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected] ASX Announcement Imugene Reports Additional Complete Response in Concurrent BTKi Cohort of azer-cel Phase 1b Trial • Additional patient in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of the azer-cel Phase 1b study achieves a complete response (CR); patient represents the first Mantle Cell Lymphoma (MCL) patient treated in the study • This Mantle Cell Lymphoma patient had previously received and failed BTKi therapy, representing a population with limited remaining treatment options • BTKi therapy addresses a US$12.0 billion global market; with a proportion of patients developing resistance with their disease progressing over time • Patient enrolment is ongoing across ten US and five Australian sites SYDNEY, Australia, 1 July 2026: Imugene Limited (ASX: IMU), a clinical-stage immuno- oncology company, today reports additional patient data from the concurrent BTK inhibitor (BTKi) cohort of its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel). This Mantle Cell Lymphoma (MCL) patient, the first MCL patient treated in the azer-cel Phase 1b study, had previously failed BTKi therapy and achieved a complete response at the Day 28 assessment. MCL is an aggressive B-cell non-Hodgkin lymphoma that typically presents at an advanced stage and remains incurable with standard therapies. BTK inhibitors have become an established treatment across relapsed or refractory MCL, but a significant proportion of patients develop resistance or intolerance over time, leaving them with limited remaining options. All patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy, a standard treatment across multiple B-cell malignancies. Despite the established efficacy of BTK inhibitors, a significant proportion of patients develop resistance over time and are left with limited remaining options. This cohort evaluates IMUGENE LIMITED ACN 009 179 551 2 whether concurrent dosing of azer-cel with a BTKi may restore or enhance therapeutic activity in this setting. The global BTKi market reached approximately US$12.0 billion in 2025. Leslie Chong, Managing Director and CEO of Imugene, said, "Achieving a second complete response in the concurrent BTKi cohort, including in the first Mantle Cell Lymphoma patient treated in the study, further reinforces our belief in azer-cel's potential for patients who have progressed on BTKi therapy. Given the broad use of BTK inhibitors across B-cell malignancies and the limited treatment options available following progression, we believe this concurrent dosing approach represents a highly promising clinical and commercial opportunity for azer-cel." To date, four patients have been dosed in the azer-cel Phase 1b concurrent BTKi cohort, two of which are evaluable, both achieving a complete response. Further updates will be provided as additional data becomes available, and the dataset matures. Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy which targets CD19 to treat blood cancers. Azer-cel is derived from healthy donor T cells and ready for administration within days, without the three-to-six-week manufacturing lead time required for autologous CAR T products. About the Phase 1b azer-cel trial The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has most recently expanded into a concurrent BTKi cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion and IL-2 has produced meaningful clinical responses across multiple indications, including multiple complete responses in the concurrent BTKi cohort. Additionally, the safety profile is manageable and generally well tolerated. IMUGENE LIMITED ACN 009 179 551 3 For more information please contact: Leslie Chong Managing Director and Chief Executive Officer [email protected] General I nvestor Enquiries [email protected] Media Enquiries [email protected] Connect with us on LinkedIn @Imugene Limited Watch us on YouTube @ImugeneLimited About Imugene (ASX:IMU) Imugene is a clinical stage cell therapy company developing an Allogeneic CAR T for blood cancers. Our lead asset is an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and together with leading specialists and medical professionals, we believe Imugene’s cellular therapy may become foundation treatments for cancer. Our goal is to ensure that Imugene is at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.

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