Targeted RNA immunotherapy platform advances toward Phase 2 IMPACT-CRC study, with IVX055 broadening the MAPK-targeted pipeline
Melbourne, Australia 28 September 2026 – ImmVirX Pty Limited, a life sciences company developing next-generation, receptor-targeted oncolytic RNA immunotherapies, is pleased to provide a summary of its operations and financial results for the financial year ended 30 June 2026.
During the year, ImmVirX continued to advance its targeted RNA immunotherapy platform, with IVX037 as the lead clinical programme and IVX055 broadening the Company’s pipeline into additional RAS- and RAF-driven cancers.
The Phase 1a IVX037 monotherapy study supported the safety and feasibility of repeat intratumoural dosing, with early activity observed in KRAS-mutant microsatellite-stable colorectal cancer. The Phase 1b IVX037 combination study with PD-1 inhibition also continued in microsatellite-stable colorectal and ovarian cancer, with preliminary data supporting a focus towards MAP kinase (MAPK)-mutated disease[1].
- IVX037 clinical progress: Phase 1a monotherapy data supported repeat intratumoural dosing, while Phase 1b combination data provided preliminary support for continued evaluation in MSS colorectal and ovarian cancer.
- Phase 2 focus: The next stage of development is expected to focus on the planned Phase 2 IMPACT-CRC study of IVX037 plus PD-1 inhibition in KRAS- and BRAF-mutant MSS colorectal cancer.
- Pipeline expansion: IVX055 will broaden the MAPK-targeted pipeline through a differentiated tumour-entry receptor, with planned clinical entry in early 2027.
- Manufacturing and CMC readiness: GMP manufacture is established through a US-based CDMO, with long-term stability demonstrated and a scalable supply chain in place for multicentre studies.
- Strong financial position: At 30 June 2026, ImmVirX had cash and financial assets of approximately $16.2 million with a runway to early 2028.
The planned IMPACT-CRC study, subject to a further financing, is intended to confirm clinical benefit in a large defined patient population and support a potential registration pathway.
Financially, ImmVirX maintained a strong balance sheet while funding ongoing clinical, manufacturing and preclinical activity. R&D expenditure was $8.8 million as the Company recorded an accounting loss of $6.4 million and a net operating cashburn of $3.9 million. $6.3 million in cash was received during the year from the R&D tax incentive programme in respect of qualifying R&D activities for the prior financial year.
ImmVirX retains an experienced management and operations team, institutional investor backing, disciplined capital allocation and a de-risked CMC programme, positioning the Company to progress IVX037 toward registration-directed studies while advancing IVX055 as a second MAPK-targeted asset.
ImmVirX CEO, Dr Malcolm McColl, commented on FY26:
“We have continued to build the clinical and translational evidence base for IVX037 and sharpened our development focus on molecularly defined colorectal cancer. The emerging data support our belief that targeted RNA immunotherapies can play an important role in tumours which are difficult to treat with standard immunotherapy approaches.”
Dr McColl added: “We are now focused on progressing IVX037 toward the planned Phase 2 IMPACT-CRC study while preparing IVX055 to enter the clinic as our second MAPK-targeted asset. We finished the year with a strong balance sheet and a scalable manufacturing position, giving us a solid platform for the next stage of development. We also look forward to presenting further updates at leading US oncology conferences in the coming months.”
[1] The MAP kinase (MAPK) pathway helps regulate cell growth. KRAS and BRAF are genes in this pathway; mutations can cause cancer cells to grow and divide unchecked. An estimated 159,000 people will be diagnosed with colorectal cancer in the United States in 2026, including approximately 36,000 whose cancer has already spread to other parts of the body. Applying the estimated mutation rates in metastatic colorectal cancer, approximately 15,000–18,000 of these newly diagnosed metastatic patients may have a KRAS mutation and 4,000–5,000 may have a BRAF mutation. Patients whose cancer progresses despite standard therapies need more effective treatment options.
About ImmVirX
ImmVirX is developing targeted oncolytic immunotherapies for cancer patients with advanced/metastatic disease and limited treatment options. Our lead asset, IVX037, is currently in clinical studies, and our second candidate, IVX055, is expected to enter the clinic in early 2027.
Our novel therapies harness the power of viruses to preferentially infect and destroy cancer cells while stimulating the immune system to generate both innate and adaptive anti-tumour responses. By combining direct oncolytic activity with immune activation, our approach is designed to enhance the body’s ability to recognize and eliminate cancer.
Our proprietary bio-selection platform enables the development of RNA viruses that target receptor proteins highly expressed on specific cancer cell types. Through this targeted approach, our oncolytic virotherapies seek to improve the effectiveness of immunotherapy in cancers with high unmet need.
Website: https://www.immvirx.com/
X: https://x.com/ImmVirX
LinkedIn: https://www.linkedin.com/company/immvirx
Media Contact
Dr. Malcolm McColl
Chief Executive Officer, Acting Chairman and Co-Founder
E: [email protected]