drugset / Press release

Third response in concurrent BTKi Cohort of azer-cel Trial

2026-07-26 · Imugene Limited · original weblink.com.au ↗

IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected] ASX Announcement Imugene Reports Third Response in Concurrent BTKi Cohort of azer - cel Phase 1b Trial • Third response achieved in concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of the azer-cel Phase 1b study • Second Follicular Lymphoma (FL) patient in the cohort reports a partial response (PR); this patient had previously received and progressed on a BTKi therapy • Both Follicular Lymphoma patients treated in the concurrent BTKi cohort have demonstrated response to treatment with concurrent azer-cel and BTKi. • BTKi therapy addresses a US$12.0 billion global market, with a proportion of patients developing resistance and their disease progressing over time • Patient enrolment is ongoing across ten US and five Australian sites SYDNEY, Australia, 27 July 2026: Imugene Limited (ASX: IMU), a clinical-stage cellular therapy company, today reports additional patient data from the concurrent BTK inhibitor (BTKi) cohort of its ongoing azer-cel (azercabtagene zapreleucel) Phase 1b clinical trial. This Follicular Lymphoma (FL) patient, the second FL patient treated in the concurrent BTKi cohort, had previously progressed on BTKi therapy and achieved a partial response at the Day 28 assessment. Both Follicular Lymphoma patients treated in the cohort to date have responded to concurrent treatment with azer-cel and a BTKi. FL is the most common indolent B-cell lymphoma and, while many patients respond to initial treatment, it remains a high unmet need with many patients relapsing over time. 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. Paul Hopper, Executive Chairman of Imugene, said, "An additional response in the concurrent BTKi cohort, and the second in Follicular Lymphoma, adds to the early signal we are seeing in patients who have progressed on BTKi therapy. Each additional response strengthens our confidence in the rationale for dosing azer-cel concurrently with a BTKi and supports our belief that this approach can address a clear unmet need across a range of blood cancers." To date, 5 patients have been dosed in the azer-cel Phase 1b concurrent BTKi cohort. 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-Hodgkin lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenström 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: General Investor 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 Board of Directors, Imugene Limited.

The release as fetched from its publisher. weblink.com.au ↗