Melbourne, Australia 1 October 2024 – ImmVirX Pty Limited, a life sciences company dedicated to pioneering the next generation of receptor-targeted immunotherapies for patients confronted with common yet formidable cancers, is pleased to provide a summary of its operations for the financial year ended 30 June 2024.
The principal activity during the financial year was the continued advancement of the oncolytic virotherapy program through pre-clinical studies and in the clinic. The bio-selected lead candidate virus (IVX037) successfully progressed through phase 1a dose escalation studies with promising early signals of activity whilst being well tolerated in late stage MSS colorectal and gastric cancer patients. Four sites are actively recruiting patients with further Australian sites under assessment to join the Phase 1b study in the second half of 2024.
In February 2024 the Company entered into a clinical trial collaboration and supply agreement with Innovent Bio to evaluate the combination therapy of IVX037 with Innovent’s TYVYT® (sintilimab) in late-stage cancer patients. TYVYT® is a leading anti-PD-1 inhibitor in the Chinese market. Preparations have been completed to enable initiation of this important phase of the study in October 2024.
ImmVirX’s Newcastle team achieved considerable progress across preclinical development, quality and product manufacture. The company-initiated development of a second oncolytic virus asset, IVX055, to specifically target late-stage lung cancer. Preclinical work demonstrates impressive activity in this setting. The company is now progressing towards manufacture of IVX055 for clinical trial commencement in the second half of 2025.
Improvements in the stability and commercial scale-up potential for IVX037 were also advanced during the year. Encouraging results from preclinical assessment of IVX037 in liver cancer cell lines indicates this will be a potential future opportunity.
The company continues to operate efficiently with a lean corporate team. In April 2024 the Company appointed Dr Oksana Zdanska as Medical Director. Dr. Zdanska has extensive experience in clinical trials, most recently in a senior leadership role at the Kinghorn Cancer Centre, one of Australia’s leading clinical trial sites.
Prudent and efficient cash management remains an important theme. Operational and capital cashburn for the year increased compared with 2023, reflecting the considerable expansion of ImmVirX’s clinical program. This included progression of the IVX037 clinical trial, ongoing US contract manufacture of IVX037 and the broadening of the company’s preclinical program. Management remains focused on maximizing the allocation of spending to these critical value drivers for the business.
The development and preclinical assessment of IVX055 has generated important intellectual property. Know how from improvements in scale up and manufacture of IVX037 has also further strengthened the IP position around that asset.
Two production batches of IVX037 have been completed at ImmVirX’s US contract manufacturer, with fully filled and finished drug product delivered to Australia for use in the clinical trial.
ImmVirX CEO, Dr Malcolm McColl, commented on FY24: “Having been in the clinic over a year now, we are very excited to see some promising early signals from monotherapy in patients carrying particularly serious and challenging tumor burden. We look forward to seeing outcomes for patients under combination therapy through our collaboration with Innovent Bio. In the coming year we will seek to broaden our portfolio by bringing a second asset into the clinic and exploring the potential of our agents in combination with CAR-T therapies. We remain in a solid financial position, with a strong team and look forward to another busy year for the company.”
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]
