Announcement • Apr 30
Imugene Limited has completed a Follow-on Equity Offering in the amount of AUD 12 million. Imugene Limited has completed a Follow-on Equity Offering in the amount of AUD 12 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 35,445,999
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 31,220,668
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Announcement • Jan 02
Imugene Limited Announces Resignation of Dr. Bradley Glover as Chief Operating Officer Imugene Limited announced that Dr. Bradley Glover has resigned from his position as Chief Operating Officer of Imugene to focus on his other business interests. The Company will manage the transition of responsibilities with no impact on business operations or ongoing programs. Announcement • Oct 14
Imugene Limited, Annual General Meeting, Nov 13, 2025 Imugene Limited, Annual General Meeting, Nov 13, 2025. Location: at automic pty ltd, level 5, 126 phillip street, sydney nsw 2000 Australia Announcement • Jul 14
Imugene Limited Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL Imugene Limited announced new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappear of all signs of cancer in response to treatment. 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). Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Fourth Quarter 2025, with the US FDA to present the data and to discuss designs for a pivotal /registrational trial for azer-cel. 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. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Announcement • Nov 15
Imugene Limited Announces Retirement of Jens Eckstein as Non-Executive Director Imugene Limited announced Jens Eckstein has resigned from his position as a non-executive director of the company to focus on his other business interests. Jens has been a valued member of the company's board since May 2019, providing extensive insights and guidance to the company. Announcement • Oct 14
Imugene Limited, Annual General Meeting, Nov 14, 2024 Imugene Limited, Annual General Meeting, Nov 14, 2024. Location: mccullough robertson, level 32, 25 martin place, sydney, nsw 2000 Australia Announcement • Sep 03
Imugene Limited Announces Promising Results from its Phase 1b Clinical Trial with Azer-Cel Imugene Limited announced promising results from its Phase 1b clinical trial with azer-cel (azercabtagene zapreleucel, an allogeneic off-the-shelf CD19 CAR T), in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL), a type of non-Hodgkin's lymphoma (NHL). All enrolled patients had cancer that had returned following autologous CAR T therapy, a high unmet need for this patient population. Patients in the trial are being recruited across 15 leading cancer centres in the U.S. including, Columbia University, University of Minnesota, Emory, and Moffitt Cancer Centres and plans are ongoing to open up to 5 sites in Australia. Results: Evaluable: patients who qualify for at least their first 28-day scan; Overall response rate (ORR): the percentage of people in the study who have a complete response (CR) or partial response (PR) to the treatment as confirmed by scan; Responses: a complete response (CR) is defined as disappearance of all tumours; a partial response (PR) is defined as a reduction in tumours as confirmed by scan; Durability of Response (DOR): how long responses last. Nine (9) patients total from Cohorts A and B are considered evaluable (qualified for at least day 28 scan). One (1) patient (Cohort B) has been treated and is awaiting their 28-day scan: Of the 6 evaluable patients in Cohort A: 1 CR, 1 PR = 33% Overall Response Rate (ORR);1 CR = 17% CR; Durability of response was < 60 days; All patients no longer on trial. Of the 3 evaluable patients in Cohort B: 2 CRs = 67% ORR; 2 CRs = 67% CR; 1 Stable Disease (SD): On PET/CT scan imaging, patient’s tumour has decreased however, due to potential T-cell infiltration, noted an increase in signal intensity. This could represent pseudoprogression. The patient remains on trial and continues to be assessed for response at the follow up scans. Durability of response thus far: >120 days and >90 days (all patients are ongoing) All 4 patients (including 1 patient awaiting 28-day scan) continue on trial. The company will continue to enrol additional patients in Cohort B and follow patients for durability of response with the goal of providing a comprehensive package to the FDA for the potential Phase 2/3 registrational trial. Subject to patient recruitment, the company aims to provide an interim Phase 1b data update. If successful, azer-cel has the potential to become the first approved allogeneic CAR T cell therapy for blood cancer. Beyond studying its efficacy in blood cancers, in the future, Imugene plans to combine azer-cel with its novel onCARlytics program for the treatment of patients with solid tumours, opening a potentially large market for azer-cel in the 90% of cancer not classified as blood cancers. Announcement • Apr 17
Imugene Limited Announce Enrolment Opened for Its Expansion Study in Bile Tract Cancer (Cholangiocarcinoma) Patients Imugene Limited announced that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA). The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma. Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs. One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days. A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA. In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability. On Friday 12 April 2024, the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, with no safety signals seen to date. In addition to the patients dosed in the monotherapy dose escalation portion of the trial, enrolment is ongoing for the VAXINIA and pembrolizumab combination portion of the trial, with 16 patients dosed to date. The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Further dose escalation to continue as long as no safety issues are observed. Announcement • Mar 12
Imugene Limited Announces Phase 1 onCARlytics Solid Tumour Trial Advances to Combination Arm Treatment Imugene Limited announced that its Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4) has cleared its first cohort within the intratumoral monotherapy arm of the study and is therefore ready to commence combination dosing solid tumour patients with CD19 targeting drug blinatumomab (Blincyto marketed by Amgen). Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab. The combination arm of the study will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto by Amgen which currently is specifically approved only for liquid blood cancers). onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone and will represent a paradigm shift in solid tumour treatment. OASIS is a dose escalation trial that will be conducted across multiple sites across the United States, with 52 patients proposed to take part in the trial. onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies. Announcement • Oct 30
Imugene Limited, Annual General Meeting, Nov 30, 2023 Imugene Limited, Annual General Meeting, Nov 30, 2023, at 15:00 AUS Eastern Standard Time. Location: McCullough Robertson, Level 32, 25 Martin Place, Sydney NSW 2000 Sydney New South Wales Australia Agenda: To consider and receive the financial report, the Directors’ report and the auditor’s report for the year ended 30 June 2023; to consider the Election of Director – Ms Kim Drapkin; to consider the Approval of amended Employee Share Option Plan; to consider the Issue of performance rights to Director – Mr Paul Hopper; and to consider other matters. Announcement • Sep 05
Imugene Limited Appoints Paul Woodard as Chief Medical Officer Imugene Limited announced the appointment of Dr Paul Woodard as Chief Medical Officer. Prior to joining Imugene Ltd, Dr Woodard worked on a wide range of drug development projects in solid tumours, haematologic malignancies, and non-malignant haematologic disorders. Most recently, Dr Woodard served as the Senior Vice President and Chief Medical Officer at Immune-Onc Therapeutics. In this role, he played a pivotal part in clinical oversight, notably directing the submission of four novel INDs (investigational new drug application) and initiating Phase 1 clinical trials. At Exelixis, Dr Woodard worked on small molecule tyrosine kinase inhibitors for solid tumours. At Amgen, Dr Woodard was the global development leader for Nplate® (romiplostim) in immune thrombocytopenia and myelodysplastic syndromes. At Genentech, Dr. Woodard was the global development team leader for Tecentriq® (atezolizumab) in haematologic malignancies and was an integral team member for the development of Tecentriq® combinations in solid tumours (including triple negative breast cancer) and haematologic malignancies. At Bellicum, Dr Woodard was the Senior Vice President of Clinical and Medical Affairs, with oversight of the company's cellular therapy portfolio and clinical trials in haematologic malignancies and solid tumours. Dr Woodard has an extensive haematology and oncology background gained in academia and industry. His academic experience focused on paediatric haematopoietic stem cell transplantation and haematologic disorders at world-renowned institutions, including St. Jude Children's Research Hospital, University of California, San Francisco, and Children'sHospital, Los Angeles. In addition to patient care, at St. Jude, Dr Woodard was responsible for Phase 1/2 trials in paediatric haematopoietic stem cell transplantation for malignant and non-malignant disorders. Dr Woodard earned his B.A. in Chemistry and M.D. from the University of North Carolina. His post-graduate journey includes a Residency at the University of Virginia andFellowships at both the University of North Carolina and the University of Minnesota. Announcement • Sep 01
Imugene Limited Appoints John Byon as Senior Vice President of Clinical Development Imugene Limited announced the appointment of Dr. John Byon as Senior Vice President of Clinical Development. Dr. Byon boasts an extensive background in the development of novel therapeutics for cancer patients. He has occupied several leadership roles at major biopharmaceutical companies, spearheading clinical development activities. Most recently, Dr. Byon served as Vice President of Clinical Development in Hematology and subsequently in acute myeloid leukemia (AML) at Fate Therapeutics. Here, he directed the clinical strategy for the Hematology portfolio, which comprises five assets in B-cell malignancies, AML, and Multiple Myeloma. He provided oversight for all ongoing Hematology trials as well as playing a pivotal role in restructuring the Clinical Development team. Before his tenure at Fate, Dr. Byon was the Senior Medical Director, Head of Clinical Science at Lyell Immunopharma. In this capacity, Dr. Byon led clinical strategy development for portfolio assets, established the internal clinical science function, and represented clinical development in joint collaborations. Additionally, Dr. Byon served as Senior Medical Director at Juno Therapeutics, where as the Global Clinical Development Lead he was instrumental in the clinical development of orvacabtagene autoleucel (orva-cel/JCARH125) for relapsed/refractory multiple myeloma and other novel CAR T-cell targets. He also assumed various Medical Director roles over a four-year span at Genentech, focused largely on managing clinical development activities for Tecentriq® (Atezolizumab) in various hematological malignancies. During this period, he conceptualized new clinical trials and represented the company at global advisory board meetings. Dr. Byon holds both a Doctor of Medicine and a Doctor of Philosophy from Tulane University. Beyond his corporate experience, Dr Byon has contributed to multiple academic publications in the hematology and oncology spaces. Announcement • Aug 21
Imugene Limited Appoints Dr Bradley Glover as Chief Operating Officer Imugene Limited announced the appointment of Dr Bradley Glover as the Company's Chief Operating Officer. Dr Glover brings a wealth of experience to Imugene, with a career spanning various sectors such as cell therapy, biopharmaceuticals, diagnostics, venture capital, finance, research and development, and education. He has demonstrated expertise in deal negotiations, strategic collaborations, acquisitions, and licensing agreements.Additionally, he has made significant academic contributions, with published research articles in biochemistry and genetics. Prior to joining Imugene, Dr Glover served as the Executive Vice President and Chief Operating Officer at Celularity, playing a pivotal role in strategic planning, business development, and technical operations. Prior to this he was Vice President and Head of Corporate Strategy & Operations at renowned cell therapy company Kite Pharma, overseeing global corporate strategy, planning, portfolio management, product and program management, and global business transformation. Dr Glover also brings eight years' experience at Genentech /Roche, where he held leadership positions, concentrating on business development, integration, and strategic planning. Notably, he helped lead the integration of Roche's acquisitions, totalling $1.2 Billion, for its Diagnostics Sequencing business. Dr Glover holds a PhD in Biochemistry & Molecular Genetics from the University of Colorado and an MBA in Marketing & Finance from the Rady School of Management, University of California San Diego. Announcement • Jul 18
Imugene Appoints Dr Weitzman Interim Chief Medical Officer Imugene Limited announced the appointment of Dr Ron Weitzman as the Company's Interim Chief Medical Officer. Dr Weitzman brings to Imugene over two decades of global experience in the biopharmaceutical industry, with expertise in the therapeutic areas of solid-tumour and hematologic malignancies. He has an extensive record in creating and executing clinical development plans, directing Phase I - III clinical trials, and preparing US and EU regulatory submissions. Prior to joining Imugene, Dr Weitzman held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech, and Novartis. Most recently as Chief Medical Officer at Tango Therapeutics, Dr Weitzman oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) submissions, while leading the clinical and clinical operations teams. Prior to his tenure at Tango Therapeutics, Dr Weitzman served as Vice President of Clinical Development at Exelixis for almost seven years. His role saw him take on the overall responsibility for the strategy and execution of the clinical plan for cabozantinib, a drug therapy for prostate cancer. This role included numerous visits to FDA and EMEA, authorship of regulatory documents, active participation in industry partnership meetings, and presentations to investors and the Exelixis Board of Directors. California-based Dr Weitzman graduated from the University of Western Ontario, Canada, and is Board Certified by the American Board of Internal Medicine in Medical Oncology. He is an active member of several professional societies including the College of Physicians and Surgeons of Ontario, the American College of Physicians, and the American Society of Clinical Oncology. Dr Weitzman replaces the departing Dr Giovanni Selvaggi in the role of Interim Chief Medical Officer. Imugene's board and management thanks Dr Selvaggi for his service to Imugene. Announcement • Jun 21
Imugene Limited Announces Board Changes Imugene Limited announced the appointment of Ms Kim Drapkin as Non- Executive Director. With more than 25 years of experience in the biotechnology and pharmaceutical sectors, Ms Drapkin possesses a strong background in finance, capital raising, and strategic financial planning. She held the position of CFO and Treasurer at Jounce Therapeutics Inc. from 2015 until its acquisition in May 2023, having played a pivotal role in the company's growth and financing since its inception. Alongside the CEO, she represented Jounce in the investment and analyst community and was a key figure in the company's IPO and subsequent NASDAQ listing. Before joining Jounce, Ms Drapkin managed a financial consulting firm and served as interim CFO for various early-stage biotech companies, including Eleven Biotherapeutics Inc., NinePoint Medical Inc., Blueprint Medicines Corporation, Warp Drive Bio LLC, Edimer Pharmaceuticals, Avila Therapeutics Inc., and Voyager Therapeutics Inc. Prior to that, she held CFO positions at EPIX Pharmaceuticals and gained valuable experience at Millennium Pharmaceuticals. Ms Drapkin also currently serves as the audit committee chair and compensation committee member on Acumen Pharmaceuticals' board. Previously, she served on Proteostasis Therapeutics' board from 2019 to 2020 and continued on Yumanity Therapeutics' board following its merger with PTI in December 2020 until December 2022. In PTI and Yumanity, she chaired the audit committee and participated in the governance and compensation committees. Ms. Drapkin also served on transaction committees for both companies. Imugene also announces that Charles Walker has resigned from his position as a NED of Imugene on 30 June 2023 after a long period of service to focus on his other business interests. Charles has served on Imugene's Board since August 2014, including a tenure as CEO, and has provided a valued contribution and wise counsel to the Company. Announcement • Feb 02
Imugene Limited Announces VAXINIA Trial Advances to Combination Cohort 1 & Monotherapy Cohort 3 Imugene Limited announced that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33- hNIS (VAXINIA) has cleared cohort 2 of both the intravenous (IV) and intratumoral (IT) arms of the monotherapy trial, allowing it to open cohort 1 of the combination study (with Pembrolizumab) and cohort 3 for both arms of the monotherapy dose escalation. The company announced the first patient had been dosed in IV cohort 2 on 5 December 2022, with the trial continuing its unimpeded progress since. The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. The patients treated to date in the monotherapy group have received the lowest doses of VAXINIA and have demonstrated acceptable safety, allowing new study participants to receive it in combination with the immunotherapy pembrolizumab. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia. Announcement • Jan 09
Imugene Limited Receives Vaxinia Ethics Approval in Australia Imugene Limited announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia. Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia. The Australian component of the Phase I trial will be conducted under Australia's Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital located in Eastwood, South Australia. Additional clinical sites will be opened in Australia, as have already been in the US following a Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago. The primary aim of the Phase 1 trial is to determine safety and an optimal biological dose of VAXINIA (CF33-hNIS) as a monotherapy and later in combination with immune checkpoint inhibitors. Efficacy, tolerability and immune response will also be measured. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.