On July 31, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno- oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 June 2025 (Press release, Imugene, JUL 31, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0d0ee6a1-bf9b-f0a7-5414-bc82a36b02ed/IMU_Quarterly_ActivitiesAppendix_4C_Cash_Flow_Report.pdf [SID1234654647]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
CLINICAL UPDATES
Two Additional Complete Responses and Three Partial Responses in azer-cel CAR T Phase 1b trial
Subsequent to the end of the quarter, Imugene reported further encouraging clinical results from its Phase 1b trial of azer-cel (azercabtagene zapreleucel), an allogeneic "off- the-shelf" CD19-targeting CAR T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Since the Company’s last update in February 2025, five additional patients have been treated in the trial. Of these, two achieved complete responses (CRs), defined as the disappearance of all signs of cancer, and three achieved partial responses (PRs), where tumours reduced in size by at least 50%. This brings the trial’s total best response rate to six complete responses and three partial responses bringing the overall response rate (ORR) to nine out of twelve patients, corresponding to a 75% ORR and a 55% CR rate.
The first patient treated remains cancer-free 15 months after dosing, while others have sustained responses for periods of greater than 2, 5, and 11+ months. The response durability continues to mature as more data accumulates. These patients had previously failed at least three, and in some cases up to six, prior lines of therapy, including autologous CAR T-cell therapies highlighting the potential of azer-cel in a high unmet- need population that has exhausted conventional treatment options.
Unlike currently approved autologous CD19 CAR T cell products, which require patient- specific manufacturing and face logistical limitations, azer-cel is designed as an allogeneic (donor-derived), off-the-shelf therapy that could significantly improve access and treatment timelines. Patients in this study are treated with a combination of lymphodepletion, azer-cel, and interleukin-2 (IL-2), a cytokine known to enhance CAR T- cell function and longevity.
Given the strength of the data and the FDA Fast Track Designation already granted for DLBCL, Imugene intends to meet with the US Food and Drug Administration in Q4 CY25 for a Type B (End of Phase 1) meeting. This interaction will focus on discussing the design of a pivotal or registrational trial that could lead to market approval.
In parallel with these developments, the azer-cel trial will now expand its scope to include other B-cell lymphomas in CAR T-naïve patients (those who have not previously received CAR T therapy). These include rare and underserved cancers such as primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and Waldenström macroglobulinemia (WM). Each of these indications currently suffers from limited treatment options in the relapsed/refractory setting, especially in patients who are ineligible for or unresponsive to existing therapies.
The trial is ongoing across ten sites in the United States, with up to six Australian sites planned.
First dose level cleared in IV combination arm of Phase 1 onCARlytics trial
In April, the Company announced the clearance of the first dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics clinical trial, known as OASIS. This milestone followed the successful completion of the initial safety observation period and allows the study to progress to the next dose level.
The OASIS trial is a first-in-human study targeting adult patients with advanced or metastatic solid tumours. Its aim is to evaluate both the safety and efficacy of two administration routes; intratumoural (IT) and intravenous (IV), for delivering the onCARlytics therapy. This therapy uses an engineered oncolytic virus (CF33-CD19) to make solid tumours express the CD19 protein, a well-validated target in blood cancers. By enabling CD19 expression in solid tumours, the trial seeks to make them susceptible to treatment with existing CD19-targeted therapies, such as the bispecific monoclonal antibody blinatumomab (Blincyto), which is used in combination with onCARlytics in this trial.
MAST Phase 1 Trial for VAXINIA in Bile Tract Cancer
The Metastatic Advanced Solid Tumours (MAST) trial evaluating CF33-hNIS (VAXINIA) continues to support the potential clinical benefit of our oncolytic virotherapy.
The expansion cohort has completed its first group of three patients without any dose- limiting toxicities, and the cohort remains open. The FDA has granted Orphan Drug Designation (ODD) for VAXINIA in biliary tract cancer, providing a range of regulatory and financial incentives to support ongoing development and potential partnering opportunities.
First Patient Dosed in Australia for PD1-Vaxx Neo-POLEM Phase II trial
In June, the first patient was dosed in Australia at the Queen Elizabeth Hospital in Adelaide as part of the Phase II Neo-POLEM clinical trial investigating its PD1-Vaxx immunotherapy. This investigator-sponsored trial is focused on patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer, a subtype representing approximately 15% of all colorectal cancer cases.
Neo-POLEM is a neoadjuvant study, meaning treatment is administered prior to surgery. The trial is evaluating the potential of PD1-Vaxx, a therapeutic cancer vaccine designed to elicit an immune response against the PD-1 checkpoint protein to improve treatment outcomes in patients with early-stage, resectable disease. The vaccine aims to activate the patient’s immune system to target and reduce tumours before surgery is performed.
The trial is being conducted in collaboration with the Cancer Research UK Southampton Clinical Trials Unit, Royal Surrey Hospital NHS Foundation Trust, and the Australasian Gastro-Intestinal Trial Group (AGITG). Recruitment will span both Australia and the United Kingdom.
The study’s primary objective is to assess major pathological response, specifically tumour reduction post-treatment. Secondary objectives include evaluating safety, identifying biomarkers of immune response, and measuring overall response and survival outcomes.
PATENT PROTECTIONS
US patent issued for onCARlytics
Imugene received a Notice of Allowance from the United States Patent and Trademark Office for its patent application covering the onCARlytics platform. The patent, titled "Oncolytic Virus Expressing a CAR T Cell Target and Uses Thereof," protects both the composition and method of use of the Company’s CD19-expressing oncolytic virus technology. Subsequent to the end of the quarter, Imugene received notice of issue from the USPTO with a patent term extension of 110 days resulting in protection until November 28, 2038.
PD1-Vaxx patent portfolio further strengthened
In June 2025, the PD1-Vaxx cancer vaccine patent portfolio was further strengthened after receiving a Notice of Grant from the US Patent and Trademark Office (USPTO) confirming that US patent application no. 16/966442 has now issued as a patent. The official patent number is 12311019. The patent entitled "Vaccine Composition and Uses Thereof" received a 1110 day patent term extension from the USPTO meaning the patent is in force until February 2042.