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Strong recruitment with 14 patients to date – four sites open + more shortly.
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Well tolerated, no dose-limiting toxicities.
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Signs of anti-cancer monotherapy activity in 2 of first 10 late-stage colorectal cancer patients evaluable for response.
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Late-stage colorectal cancer patient with complete response in injected lesion and no new metastatic disease over one year since commencing treatment.
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Elevation of beneficial inflammatory cytokines/chemokines, such as CXCL10.
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Phase 1b combination with checkpoint inhibitor to open in September 2024.
Melbourne, Australia 16 August 2024 – ImmVirX Pty Limited, a life sciences company developing next-generation, receptor targeted oncolytic viral 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 that was presented at the 45th Annual Meeting of the Medical Oncology Group of Australia (MOGA) in Sydney.
The study, a Phase 1a/b open-label, non-randomized, multi-centre clinical trial of intratumoral IVX037 alone and in combination with anti-PD1 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer is ongoing at four sites in Australia.
“Our study is targeting some of the most common cancer types worldwide, where long term survival rates are low. We are delighted by progress to date, including excellent tolerability and some early encouraging signals of activity in patients with late-stage disease that have failed available therapies,” said ImmVirX Managing Director Dr Malcolm McColl. “In addition, we have excellent clinician engagement with an expectation for rapid progress through the Phase 1b stage of the study where we will evaluate IVX037 with the anti-PD1, TYVYT®, from Innovent Bio.”
Fourteen patients have enrolled in the Phase 1a monotherapy study. The dose escalation phase in Cohorts 1-3 has been completed, with Cohort 3 expansion dosing ongoing. IVX037 intratumoral administration has been generally well tolerated with no dose-limiting toxicities observed. It has been successfully administered to liver, lymph node and abdominal metastases.
In the dose escalation phase, there have been promising signals of anti-cancer activity in two of ten late-stage response evaluable colorectal cancer patients with reduction in disease burden and corresponding reduction in the serum biomarker (CEA) levels.
Serum biomarker analysis also indicates early signs of IVX037 induction of potentially beneficial inflammatory cytokines/chemokines, such as CXCL10. Elevation of CXCL10 has been correlated to increased likelihood of responses to subsequent therapy with checkpoint inhibitors.
Recruitment is ongoing with new sites expected to commence shortly. The Phase 1b stage in combination with anti-PD1, sintilimab (TYVYT®), is forecast to start in September 2024.
“I am greatly encouraged by the results so far through the dose escalation and expansion component of this study, showing that IVX037 is tolerable with early signals of activity,” 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. “I look forward to commencing the Phase 1b component of this trial to examine the potential for synergistic benefits of IVX037 administration in combination with a checkpoint inhibitor.”
“I am pleased with the progress of IVX037 monotherapy in my advanced colorectal cancer patients. It is particularly encouraging to see a complete response in an injected target lesion with confirmation by histologic assessment. This patient has no evidence of new metastatic disease since commencing the trial treatment (over 1 year ago) with no other anti-cancer therapy since treatment completion (~ 9 months ongoing). This is suggestive of the abscopal effect of IVX037.” said Dr Mark Wong (Crown Princess Mary Cancer Centre, Westmead Hospital).
The MOGA poster presentation is available on the ImmVirX website. Details of the study can be found at ClinicalTrials.gov Identifier: NCT05427487.
About MOGA
The Medical Oncology Group of Australia Incorporated (MOGA) is the national, professional organisation for medical oncologists and the profession in Australia. As a Specialty Society of the Royal Australasian College of Physicians, MOGA maintains strong strategic alliances, working in close collaboration with professional organisations and agencies in Australia and overseas. They work with Government, health organisations, affiliated international associations and societies, industry and learned Colleges to improve and develop the profession of medical oncology and the management of cancer both nationally and globally.
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.
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]
