Clinical

Therapeutic Strategy

Combining viral oncolysis with immune activation

Immunotherapies have transformed the treatment of several cancers, but many patients with solid tumours do not benefit. In cancers such as microsatellite-stable colorectal cancer, immune suppression within the tumour microenvironment does limit anti-tumour immune activity.

Oncolytic immunotherapies are designed to destroy tumour cells and stimulate anti-tumour immune responses. ImmVirX is investigating whether this approach can address barriers to immune activity in cancers with high unmet need, including through combinations with immune checkpoint inhibitors (ICIs).

Our proprietary bioselection platform identifies RNA viruses with the ability to preferentially replicate in and destroy tumour cells. This direct oncolytic activity may also promote innate and adaptive anti-tumour immune responses. Our clinical studies are evaluating the safety and anti-tumour activity of these investigational therapies, including in combination with PD-1 inhibitors.

Specifically, our oncolytic immunotherapies are being developed to:

Promote inflammation in immunologically “cold” tumours with limited responsiveness to immune checkpoint inhibitors.
Promote immune cell infiltration into tumours.
Stimulate innate and adaptive anti-tumour immune responses.
Support evaluation of combinations with immune checkpoint inhibitors and, in preclinical studies, RAS/RAF pathway inhibitors.
Achieve anti-tumour activity with a favourable tolerability profile.

Clinical Trials

ImmVirX is conducting CP-IVX001, a Phase 1 first-in-human, open-label, non-randomised, multicentre study of intratumoural IVX037. Phase 1a evaluated IVX037 as monotherapy; Phase 1b evaluates IVX037 with a PD-1 inhibitor. The current development focus is KRAS/BRAF-mutant microsatellite-stable colorectal cancer, with ovarian cancer also being investigated.

Further details of the study of intratumoural IVX037, as monotherapy or in combination with an immune checkpoint inhibitor in patients with advanced or metastatic solid tumours, are available on ClinicalTrials.gov:

ClinicalTrials.gov Identifier: NCT05427487

Phase 1a evaluation of IVX037 as monotherapy has been completed in 14 patients with advanced cancer, with no dose-limiting toxicities or Grade ≥3 treatment-related adverse events attributable to IVX037 reported. Preliminary activity included tumour shrinkage in injected KRAS-mutant colorectal cancer lesions and a confirmed complete pathological response in one injected lesion. The patient remains alive more than three years after treatment, without further systemic anti-cancer therapy.

In the ongoing Phase 1b study, IVX037 is being evaluated in combination with a PD-1 inhibitor. Preliminary findings in microsatellite-stable colorectal cancer include tumour reductions in injected and non-injected lesions, with lesion-level disease control observed more frequently in KRAS/BRAF-mutant disease. An ongoing partial response has also been reported in a patient with ovarian cancer. These findings are preliminary and require confirmation in larger studies.

ImmVirX plans to advance IVX037 into the Phase 2 IMPACT-CRC study, evaluating IVX037 plus a PD-1 inhibitor in KRAS- and BRAF-mutant microsatellite-stable colorectal cancer at Australian and US sites. The study is intended to further characterise clinical activity and explore the relationship between MAPK pathway mutations and treatment outcomes, supporting the development of a potential registration pathway. Progression is subject to financing and the required approvals.

For the latest programme updates and clinical data, see our corporate presentation in the Investor Centre.

Collaborations

Collaboration with BeOne Medicines

ImmVirX has a clinical supply agreement with BeOne Medicines AG (“BeOne”) to evaluate IVX055 in combination with tislelizumab, BeOne’s PD-1 inhibitor. The agreement supports the planned clinical evaluation of the combination in Australia, assessing safety, tolerability and preliminary anti-tumour activity.

Collaboration with Innovent

ImmVirX has a clinical trial collaboration and supply agreement with Innovent Biologics, Inc. (“Innovent”) to evaluate IVX037 in combination with TYVYT® (sintilimab), Innovent’s PD-1 inhibitor. Innovent supplies sintilimab for the Phase 1b study in Australia, which includes patients with advanced colorectal, ovarian, gastric and liver cancers.