Phase 1b trial will evaluate IVX037 and Innovent Bio’s anti-PD-1 inhibitor TYVYT® (sintilimab) in patients with late stage colorectal, gastric and ovarian cancer
Trial open at 4 sites with further sites to open through Q4.
Melbourne, Australia 28 October 2024 – 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 two patients have been dosed in its CP-IVX001 Phase 1b trial.
The trial is assessing the combination of ImmVirX’s IVX037 receptor targeted oncolytic virus and Innovent Bio’s anti-PD-1 therapy TYVYT® (sintilimab) in patients with late stage colorectal, gastric or ovarian cancer, three of the most prevalent cancer types globally. It will evaluate the safety and efficacy of IVX037 with TYVYT® (sintilimab) in 45 patients across up to 8 sites in Australia.
ImmVirX CEO and Co-Founder, Dr Malcolm McColl, commented: “We are delighted to dose our first patients in the combination study with TYVYT®. It is exciting to build upon the positive signals observed with IVX037 monotherapy and to have the potential to address a significant unmet medical need.”
Dr Hui Zhou, Senior Vice President of Innovent Biologics, stated: “We are hopeful about the potential this combination therapy holds for improving the lives of cancer patients. The first patients dosed in this Phase 1b trial marks a good start and we look forward to the innovation and expertise of our partner to bring about meaningful change in the fight against cancer.”
“I am impressed with the promising clinical and biomarker signals achieved with IVX037 monotherapy in my advanced colorectal cancer patients and delighted to have dosed the first patients in the phase 1b combination trial,” said Dr Mark Wong (Crown Princess Mary Cancer Centre, Westmead Hospital). “My colleagues and I are eager to find better options for this large patient population and to assess the potential of IVX037 in combination with an anti-PD-1 inhibitor in achieving this goal.”
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, patients were enrolled into a single-arm open-label study to identify the optimal dosing regimen for Phase 1b. Phase 1b will assess the safety and efficacy of IVX037 in combination with sintilimab in up to 45 patients. Phase 1b will be conducted across up to eight clinical centres in Australia.
About ImmVirX
ImmVirX is developing novel oncolytic viruses to create powerful new cancer immunotherapy combinations. Our lead asset, IVX037, is in clinical studies with further agents 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, 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.
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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]
