Melbourne, Australia 21 September 2023 – ImmVirX Pty Limited, a life sciences company dedicated to pioneering the next wave of receptor-targeted oncolytic viral immunotherapies for patients confronted with common yet formidable cancers, presents a summary of its operations for the financial year ending 30 June 2023.
The year was headlined by the progress of IVX037, ImmVirX’s flagship drug candidate, as it entered the clinic with first human patient dosed during April 2023.
The drug is now under evaluation in a Phase 1a study for patients battling late-stage colorectal, gastric, or ovarian cancers, three of the most prevalent cancer types globally. The goal of the trial is to evaluate safety, tolerability and preliminary markers of efficacy following intratumoral administration of IVX037.
The initial stage of the study, currently underway at four hospitals in Australia, is assessing a dose frequency escalation period with 9 to 12 patients, followed by a cohort expansion stage with a further 15 patients treated with the recommended dosing regimen.
The first cohort of three patients is now complete and the second cohort of three is now fully enrolled. The study is now progressing to cohort 3 with no dose limiting toxicities.
In order to commence the trial, IVX037 was successfully produced in Australia. In tandem with this accomplishment, a US-based contract manufacturer kickstarted full-scale production, setting the stage for US clinical studies in 2024.
ImmVirX fortified its intellectual property portfolio, with new data, further know-how on an enhanced manufacturing process and formulations with the goal to enhance product stability.
The Newcastle-based R&D team, crucial to ImmVirX’s operations, grew to 21 members during the period. This team continues to achieve important milestones in development, quality, and production. The rapid and cost-efficient completion of tasks to enable the dosing of the first patient with IVX037 is a testament to the skills and experience of the team.
A key financial milestone was achieved in May with a Series B financing round, spearheaded by highly regarded venture capital firm One Ventures. Including subsequent fundraising efforts within the new financial year a total $19 million was raised. These funds provide a cash runway through to early 2026, bolstering IVX 037’s production for clinical trials, expanding and accelerating the Phase 1 trials, and driving R&D for a new oncolytic virus targeting late-stage lung cancer.
The financing round saw active involvement from existing institutional investors from prior investment rounds. Additionally, a further $2.8 million was received via the Federal Government’s R&D Tax Incentive in November 2022, for R&D work conducted by ImmVirX in FY22. The company estimates it will receive a further $4.0 million in the coming months.
Following the Series B financing round, the company was delighted to welcome Dr Jeannie Joughin from One Ventures to the ImmVirX Board of Directors. Dr Joughin’s vast experience in Big Pharma and the biotechnology sector more broadly will strengthen the ImmVirX team.
Dr Malcolm McColl, CEO, Acting Chairman and Co-Founder of ImmVirX, said: “FY23 was a pivotal year for us. Our dedicated team has ushered IVX037 from the lab to clinical trials, signalling a substantial leap in our cancer treatment journey. With robust financial backing from both returning and new investors, we’re well positioned to carry this momentum into FY24 and beyond, with the current program and with plans to expand the portfolio to additional, highly prospective assets.”
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 systemic anti-tumour immune responses.
The proprietary bio-selected RNA viruses target 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.
