First patient on trial in colorectal, gastric and ovarian cancer study (CP-IVX001)
Melbourne, Australia 11 April 2023 – ImmVirX Pty Limited, a clinical stage oncology company focused on developing next-generation, receptor targeted oncolytic viral immunotherapies to transform outcomes for patients with some of the most prevalent and challenging cancer types, today announced that the first patient has been dosed in the Company’s two-part Phase 1 clinical trial of its bio-selected oncolytic virus, IVX037.
In the first-in-human, Phase 1a part of the study, IVX037 will be assessed in patients with late stage colorectal, gastric or ovarian cancer, three of the most prevalent cancer types globally.
The goal of Phase 1a is to evaluate safety, tolerability and preliminary markers of efficacy following intratumoral administration of IVX037. The trial will commence with a dose frequency escalation period with 9 to 12 patients, treated with 1 to 3 doses of IVX037, followed by a cohort expansion stage with a further 15 patients treated at the recommended dosing regimen.
Phase 1b of the study will assess the recommended dosing regimen of IVX037 in up to 45 patients when combined with an immune checkpoint inhibitor.
ImmVirX CEO and Co-Founder, Dr Malcolm McColl, commented: “This is a key milestone for ImmVirX and I am proud of the dedication and skill applied to enable the commencement of this important study. IVX037 has been developed by our highly experienced team based in our facilities in the Hunter Medical Research Institute in Newcastle. The agent has demonstrated safety and efficacy in preclinical studies. Having only commenced operations in the first quarter of 2020 we are excited to enter the clinic and assess IVX037 in colorectal, gastric and ovarian cancer patients where there is a high unmet need for better therapies. We look forward to providing updates on clinical progress during the year.”
About the Trial
The trial is entitled “CP-IVX001: 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”. The study will be conducted in patients with colorectal, ovarian and gastric cancers which have progressed on, or are not suitable for, standard of care systemic therapies. (ClinicalTrials.gov Identifier: NCT05427487)”.
The trial is comprised of two stages. In Phase 1a, 24 to 27 patients will be enrolled into a single-arm open-label study to identify the optimal dosing regimen for Phase 1b. Phase 1b will subsequently assess the safety and efficacy of IVX037 in combination with an immune checkpoint inhibitor in up to 45 patients. Phase 1a will be conducted across four clinical centres in Australia.
ImmVirX is developing novel oncolytic viruses to create powerful new cancer immunotherapy combinations. Its 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, the viral candidates are intended to increase the effectiveness of current immunotherapies, primarily immune checkpoint inhibitors and CAR-T cell therapies, in fighting cancers of high unmet need including colorectal, gastric, ovarian and liver cancer.
Dr. Malcolm McColl
Chief Executive Officer and Co-Founder
E: [email protected]