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IMUGENE LIMITED — Capital/Financing Update 2025
Sep 17, 2025
65124_rns_2025-09-17_0e05a4c0-e17c-42e4-967d-638e41b2d24b.pdf
Capital/Financing Update
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ASX Announcement
Overall Response Rate (ORR) increases to 81% with two additional Partial Responses in azer-cel CAR T Phase 1b trial
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81% Overall Response rate (ORR): 7 total Complete Responses (CR) and 6 Partial Responses (PR) in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer
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First patient dosed in 2024 remains cancer free for more than 17 months and ongoing with subsequent patients having durable responses at 4, 5, 8, and 13 months+ and durability data continuing to mature
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Patients in the trial have previously failed at least 3 lines of therapy with many patients failing 4-6 lines of therapy, including autologous CAR-T, reinforcing the potential of azer-cel in this high unmet need population
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Trial now open to enrol into CAR T naïve niche indications in other lymphomas
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Additional updates expected in coming months
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For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response.
Sydney, Australia, 18 September 2025: Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, is pleased to announce further encouraging efficacy data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients
IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected]
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with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer.
In August 2025, Imugene announced that a total of eleven out of fourteen patients had achieved an ORR of 79%, defined as either Complete Response, (the disappearance of signs of cancer in response to treatment) or Partial Response, (defined as cancer reduction by at least 50%). Since then, two new patients have become evaluable for responses with both achieving a Partial Response and another patient transitioning from PR to CR at Day 90 scan evaluation increasing the best ORR to 81% with thirteen out of sixteen patients showing response to treatment. The Complete Response (CR) rate continues to evolve as enrollment progresses and patients transition from partial to complete response, with an average time to best response seen in 1–3 months. The durability of response is also deepening in patients treated with azer-cel in combination with interleukin-2 (IL-2)
Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).
Imugene is actively enrolling patients to the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.
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 with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability
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of response. Additionally, the safety profile is manageable and generally well tolerated.
About diffuse large B cell lymphoma (DLBCL)
DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.
1Science Direct Volume 60, Issue 5, November 2023
About primary central nervous system lymphoma (PCNSL)
PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.
About other types of B Cell Lymphoma
Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.
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About Interleukin 2 (IL-2)
IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.
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For more information please contact:
Leslie Chong Managing Director and Chief Executive Officer
General Investor Enquiries
Media Enquiries
Matt Wright
Connect with us on LinkedIn @Imugene Limited
Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in
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combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours and B-cell vaccine candidates. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally.
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 peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are 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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