Phase 1 study to investigate IVX055 with tislelizumab in difficult-to-treat cancers
Key Highlights
- ImmVirX’s receptor-targeted oncolytic virus IVX055 to be evaluated in combination with tislelizumab
- Phase 1 clinical trial planned to commence in second half 2026 in Australia
- IVX055 to become ImmVirX’s second clinical-stage asset, expanding its oncolytic immunotherapy pipeline
Melbourne, Australia – 3 February 2026 – ImmVirX Pty Ltd, a life sciences company focused on developing the next generation of receptor-targeted oncolytic immunotherapies for patients with common yet difficult-to-treat cancers, today announced that it has entered into a clinical supply agreement with BeOne Medicines AG (“BeOne”) to evaluate a combination therapy of ImmVirX’s investigational oncolytic virus IVX055 with tislelizumab, BeOne’s PD-1 (programmed death receptor-1) inhibitor, which is approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA), and Australia’s Therapeutic Goods Administration (TGA).
The Phase 1 clinical study, planned to commence in the second half of 2026, will assess the safety, tolerability, and preliminary anti-tumor activity of intratumoral IVX055 in combination with intravenous tislelizumab in patients with late-stage cancers. Approximately 32 patients are expected to be enrolled in this multi-center clinical trial in Australia. Under the terms of the agreement, BeOne will supply tislelizumab for use in the study.
“BeOne Medicines is a leading global oncology company with an impressive portfolio of approved medicines and a deep, innovative pipeline of cancer therapies,” said Dr. Malcolm McColl, CEO and Co-Founder of ImmVirX. “We are excited to collaborate with BeOne to explore the combination of IVX055, our second receptor-targeted oncolytic virotherapy, with the PD-1 inhibitor tislelizumab. It is particularly exciting to advance our second asset into the clinic, and I would like to thank our dedicated team for driving this program forward in a timely and cost-effective manner. With two therapies now in clinical development, ImmVirX is well positioned to address an expanding range of challenging cancer types.”
About IVX055
IVX055 is a proprietary oncolytic RNA virus which has been bio-selected to target receptors overexpressed on cancer cells. It is able to target, infect, replicate in, and subsequently kill tumor cells, leading to the potential generation of both innate and adaptive immune responses against cancer. The clinical goal is to use IVX055 to enhance the rate, depth, and durability of response to immune checkpoints as a therapy which has the following characteristics:
- Highly inflames “cold” tumor types with current low responsiveness to immune checkpoint therapy (CPI), including tumors that have become resistant to prior CPI treatment;
- Triggers both innate and adaptive immune responses;
- Infiltrates tumors with immune cells at a high rate;
- Activates immune stimulating genes to create synergy with immunotherapies;
- Favourable safety profile for patients;
- Off the shelf therapy / no need for personalisation.
About ImmVirX
ImmVirX is developing novel oncolytic immunotherapies to create powerful new cancer therapy combinations. Our lead asset, IVX037, is in clinical studies and our second agent, IVX055, is scheduled to enter the clinic in mid-2026. Our novel oncolytic immunotherapy harnesses the power of viruses to preferentially infect and kill cancer cells and induce local and systemic anti-tumor 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 tumor cells while creating beneficial changes in the tumor micro-environment, potentially leading to the generation of specific innate and adaptive immune responses against cancer cells.
In this way, our oncolytic virotherapy is intended to increase the effectiveness of current immunotherapies, in fighting cancers of high unmet need including colorectal, gastric, ovarian, liver, lung and bile duct cancer.
Website: https://www.immvirx.com/
LinkedIn: https://www.linkedin.com/company/immvirx
X: https://x.com/immvirx
Media Contact
Dr. Malcolm McColl
Chief Executive Officer, Acting Chairman and Co-Founder
E: [email protected]
