Melbourne, Australia 18 September 2025 – ImmVirX Pty Limited, a life sciences company dedicated to pioneering the next generation of receptor-targeted immunotherapies for patients confronted with common yet formidable cancers, is pleased to provide a summary of its operations for the financial year ended 30 June 2025.
Over the past year, ImmVirX has made significant strides in its clinical, manufacture and research programs, particularly with its lead oncolytic virus candidate, IVX037. The company successfully completed its Phase 1a monotherapy trial, which showed promising safety results—no dose-limiting toxicities were observed. Encouragingly, two of the first nine late-stage colorectal cancer patients treated in the dose escalation stage showed signs of therapeutic activity. One standout case involved a colorectal cancer patient who achieved a confirmed pathologic complete response and remained free of new metastatic lesions for more than two years since commencing trial treatment.
Building on this momentum, ImmVirX launched in October 2024 a Phase 1b combination trial evaluating IVX037 alongside TYVYT® (sintilimab), a PD-1 checkpoint inhibitor developed by Innovent Biologics. This trial targets colorectal, gastric, and ovarian cancers and has already seen strong recruitment, with 14 patients enrolled and seven clinical sites actively participating. A further site is preparing to join the phase 1b study reflecting oncologist interest in the study. It is pleasing to report that the combination therapy has been well tolerated with some promising early signals of activity. The company also expanded its collaboration with Innovent to explore the combination therapy in hepatocellular carcinoma, marking a strategic move into liver cancer.
In parallel, ImmVirX initiated preclinical development of a second oncolytic virus asset, IVX055, aimed at treating late-stage lung cancer and potentially other indications. Bulk manufacture of IVX055 for clinical trial use has been completed with finished product to be available in early 2026. The development of IVX055 reflects the company’s commitment to broadening its pipeline and addressing multiple high-need cancer indications.
ImmVirX has also been active on the scientific stage. The team presented key findings at the American Association of Cancer Research Annual Meeting in Chicago in April 2025, including two poster presentations that highlighted both clinical and preclinical progress. More recently, the company has been selected to present at the European Society of Medical Oncology Annual Meeting in Berlin in October 2025. On the local stage the company has shared updates at the Medical Oncology Group of Australia (MOGA) and Australasian Gastro-Intestinal Trials Group (AGITG) Annual Meetings, reinforcing its growing presence in the oncology research community.
Financially, ImmVirX benefited from Australia’s R&D tax incentive program, receiving $5.1 million cash offset in January 2025 arising from R&D activities in the year ending 30 June 2024. The company estimates it will receive $6.3 million in R&D tax incentive cash offsets in relation to the year ending 30 June 2025. These funds support ongoing research, manufacture and clinical trial expansion across our programme.
In a year of major advances across all areas of the business we are pleased to report an operating net cash outflow of $6.9 million.Achieving this modest cashburn in a year of expansion in the preclinical and clinical program reflects the ongoing efficiencies in operational activities and prudent financial management of the company.
Regards,
Malcolm McColl
Chief Executive Officer
About ImmVirX:
ImmVirX is developing novel oncolytic immunotherapies to create powerful new cancer therapy combinations. Our lead asset, IVX037, is in clinical studies with our second agent, IVX055, in pre-clinical development. Our novel oncolytic immunotherapy harnesses the power of viruses to preferentially infect and kill cancer cells and induce local and systemic anti-tumour immune responses.
The proprietary bio-selection platform enables the development of RNA viruses targeting specific receptor proteins highly expressed on a range of cancer cell types, allowing them to selectively enter, replicate in, and destroy tumour cells while creating beneficial changes in the tumour micro-environment, potentially leading to the generation of specific innate and adaptive immune responses against cancer cells.
In this way, our oncolytic immunotherapies are intended to increase the effectiveness of current therapies, primarily immune checkpoint inhibitors and CAR-T cell therapies, in fighting cancers of high unmet need including colorectal, gastric, ovarian and liver cancer.
Website: https://www.immvirx.com/
X: https://x.com/ImmVirX
LinkedIn: https://www.linkedin.com/company/immvirx
Media Contact
Dr. Malcolm McColl
CEO & Acting Chairman
E: [email protected]
