Clinical
Therapeutic Strategy
Powerful New Oncolytic Viruses
Harnessing the immune system to fight cancer has become established as one of the pillars of cancer treatment over the past decade, with the introduction of multiple new immunotherapies designed to activate innate or adaptive immune responses. However, many of these approaches have not proved useful in solid tumors, at least in part due to the immunosuppressive status in the tumour microenvironment (TME).
The goal of oncolytic virotherapy is to overcome immune inhibitions in the TME and thus improve the activity of immune checkpoint inhibitors (ICIs) against cancers of high unmet need. ICIs are cornerstone immuno-oncology therapies, among the world’s biggest selling drugs.
ImmVirX is developing proprietary oncolytic RNA viruses which have been bio-selected to have the greatest potency and ability to replicate in and subsequently kill target tumour cells rather than healthy cells, leading to the potential generation of specific and adaptive immune responses against cancer. Our goal is to use these viruses to enhance the rate, depth, and durability of response to immune checkpoint therapy.
Specifically, our oncolytic viruses are being developed to:
- Highly inflame “cold” tumour types with current low responsiveness to ICI therapy
- Infiltrate tumour with immune cells at a high rate
- Trigger both innate and adaptive immune responses
- Enable synergy with ICI and CAR-T therapies by activating immune stimulating genes, including through the RIG-I pathway
- Be well tolerated in patients
Clinical Trials
The company is currently conducting CP-IVX001 Phase 1 first-in-man, 2-part, open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 in people with micro satellite-stable (MSS) colorectal or gastroesophageal cancer metastatic to liver, or advanced ovarian cancer. CP-IVX001 Part 1a is a dose escalation IVX037 monotherapy, and Part 1b is IVX037 in combination with a checkpoint inhibitor.
Further details of the study – A phase 1 open-label, non-randomized, multi-cohort clinical study of intratumoral IVX037 as monotherapy or in combination with an immune checkpoint inhibitor in patients with advanced or metastatic solid tumours are available at:
ClinicalTrials.gov Identifier:NCT05427487
As of November 2023, CP-IVX001 Part 1a dose escalation Cohorts 1 and 2 have been fully recruited and Cohort 3 is open. The Phase 1b portion of the study combining IVX037 with a checkpoint inhibitor is expected to commence in the first half of 2024.
The study is currently running at several sites in Australia under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme with plans to open sites in the USA in 2024 under a US Food and Drug Administration (FDA) Investigational New Drug (IND) application.
Further information is also available on the company’s corporate deck.
Collaboration with Innovent
ImmVirX has a clinical trial collaboration and supply agreement with Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor.
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.
The study will investigate the potential benefit from combining IVX037 with the anti-PD-1 therapy, TYVYT® (sintilimab injection) by playing complementary roles in engaging the immune system to fight cancer. Under the collaboration agreement, Innovent will provide clinical drug supplies of TYVYT® (sintilimab injection) in the trial.
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