Phase 1a monotherapy trial complete
Well tolerated with no dose limiting toxicities
Confirmed pathologic complete response in a target lesion in a colorectal cancer patient with no new sites of metastatic lesions approaching two years since commencing treatment
Signs of monotherapy activity in 2 of 9 late-stage cancer patients
Induction of cell signalling proteins (cytokines/chemokines), such as CXCL10 indicative of an immune response
Phase 1b combination with checkpoint inhibitor underway at 7 Australian sites
Liver cancer patient cohort to be added to the study
Melbourne, Australia 29 April 2025 ImmVirX Pty Limited, a life sciences company focused on developing next-generation, receptor targeted oncolytic RNA immunotherapies to transform outcomes for patients with some of the most prevalent and challenging cancer types, is pleased to report on progress in its Phase 1a/b clinical study and preclinical development of its second asset, being presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago.
IVX037 Clinical Trial Update
The poster reported on the ongoing Phase 1a/b open-label, non-randomized, multi-centre clinical trial of intratumoural IVX037 alone and in combination with TYVYT® (sintilimab, a PD1-inhibitor) in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer. A further cohort of 15 hepatocellular carcinoma (liver cancer) patients will be added to the Phase 1b study by mid-year.
Multiple intratumoural administrations of IVX037 have been well tolerated with no dose-limiting toxicities observed. There has been no grade 3 or higher treatment related adverse events. IVX037 has been successfully administered to liver, lung, lymph node and abdominal metastases.
Of the 9 cancer patients administered IVX037 in Phase 1a, one MSS, KRAS G12D mutant colorectal cancer patient achieved a biopsy confirmed complete response at day 262 after five intratumoural doses. The patient was considered by the oncologist to have an exceptional response with the absence of new metastatic disease for 22 months to date without additional cancer treatments.
Two MSS colorectal cancer patients displaying reduction in injected lesions also exhibited decreased levels of CEA, a serum tumour biomarker . Serum biomarker analysis also highlighted IVX037-mediated induction of potentially beneficial inflammatory cytokines/chemokines (ie.CXCL10) at day 8. This is indicative of an immune response which enhances the likelihood of responses to the PD-1 inhibitor in the Phase 1b study.
Currently 7 patients have been enrolled in the Phase 1b part of the study. There have been no dose limiting toxicities and the combination dosing regimen has been well tolerated. The trial is ongoing at 7 Australian sites.
“I am pleased with the outcomes from the Phase 1a monotherapy study including the confirmed and durable complete response in a late-stage colorectal cancer patient. Long term survival in this setting is typically low,” said Dr Mark Wong (Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney Australia). “The signals of activity from IVX037 monotherapy, alongside the excellent tolerability from first patients in the combination Phase 1b study are encouraging.”
“I am greatly encouraged by the current results, which demonstrate meaningful progress and offer a strong foundation for continued clinical development.” said Dr Jia (Jenny) Liu, medical oncology staff specialist at The Kinghorn Cancer Centre, St Vincent’s Hospital (Darlinghurst, Sydney Australia) and Principal Investigator on the study. “We’re excited to have moved into the combination study and to open treatment options for liver cancer patients.”
Dr Malcolm McColl, CEO and Co-Founder of ImmVirX comments: “The strength of the early data and promising clinical signals give us confidence as we move into the next stages of development. We are grateful to the investigators and participants who have made this possible.”
IVX037 and IVX055 Preclinical Update
Novel oncolytic RNA viruses, IVX037 and IVX055, demonstrate potent antitumor activity
The poster reported preclinical results from our two novel oncolytic non-enveloped RNA viruses, IVX037 and IVX055. Both are small, single stranded RNA viruses, using independent cell surface receptors to facilitate tumour targeting, cell entry, subsequent potent lytic replication and cancer cell death.
IVX037 demonstrated potent oncolytic in vitro activity in human ovarian, gastric, and hepatocellular cancer (HCC) cell cultures. Intratumoural and intravenous administration of IVX037 in human tumour xenograft models using immunocompromised mice was well tolerated and displayed potent anti-tumor activity against ovarian, gastric and liver cancer. Intratumoural IVX037 challenge of human MSS-colorectal cancer xenografts increases expression of PD-L1 and mediates a widespread inflammation phenotype, suggested to allow increased migration of anti-tumour lymphocytes, elevation of cellular targets for immune checkpoint and cell-based anti-cancer therapies.
IVX055 induced rapid cell lysis in non-small cell lung, HCC and human bladder cancer in vitro cell preparations. Planning is underway for a Phase 1a/b clinical trial to evaluate IVX055 in combination with immune checkpoint therapy in patients with advanced/metastatic non-small cell lung cancer. Preliminary in vitro combination studies with mesothelin-targeted CAR T-cells and IVX037 suggest enhanced tumor cell killing compared to that of either agent alone in a human gastric cancer cell culture model.
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, liver cancer and non-small cell lung cancer.
About the Phase 1b Combination Study
The Phase 1b study is an open-label, non-randomized, multi-center clinical trial of intratumoural IVX037 in combination with an intravenous immune checkpoint inhibitor, sintilimab (PD-1 inhibitor) in patients with advanced MSS-colorectal, gastroesophageal, ovarian and liver cancer. A total of 60 participants (15 from each of the four tumour types) will be enrolled and receive IT doses of IVX037 administered on Days 1,15,29,43,57,71 and 85. Sintilimab administration will commence on Study Day 8 and be administered every 3 weeks through to Study Day 344.
The primary objective is to determine the safety and efficacy of intratumoural IVX037 in combination with sintilimab when administered to patients with advanced colorectal, ovarian, gastric and liver cancer. Tumour response is being assessed using iRECIST, with the first response assessment occurring at Day 43. Several biomarker effects of IVX037 administration in peripheral blood and tumour tissue addressing tumour infiltrating lymphocytes and cellular target expression levels for immune checkpoint therapies will be assessed. ctDNA levels will also be monitored.
Website: https://www.immvirx.com/
Twitter: https://twitter.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]
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1 TYVYT® (sintilimab injection, Innovent)
2 CEA: Carcinoembryonic antigen is a protein that may be elevated in many colorectal cancer patients and is detected in the blood. CEA levels are measured during treatment to assess the effectiveness of treatments.
