🐂 Not all bull runs are created equal. November’s AI picks include 5 stocks up +20% eachUnlock Stocks

Imugene gets ethics green light to start Australian Phase 1 trial of oncolytic virotherapy candidate VAXINIA

Published 09/01/2023, 10:46 am
Updated 09/01/2023, 11:00 am
© Reuters.  Imugene gets ethics green light to start Australian Phase 1 trial of oncolytic virotherapy candidate VAXINIA

Imugene Ltd (ASX:IMU, OTC:IUGNF) has received Human Research Ethics Committee (HREC) approval to kick off an Australian Phase 1 clinical trial of its oncolytic virotherapy candidate, VAXINIA (CF33-hNIS).

Ethics approval confirms the company has met all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia.

The Phase 1 trial will be conducted under Australia’s Clinical Trials Notification Scheme, meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities.

Trial to kick off in South Australia

The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital in Eastwood, South Australia.

Additional clinical sites will open across the country, following the US, where the company received Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago.

The trial, named 'A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)', is expected to run for 24 months, funded from existing budgets and resources.

The primary aim of the trial is to determine safety and an optimal biological dose of the drug as a monotherapy and later in combination with immune checkpoint inhibitors.

Efficacy, tolerability and immune response will also be measured.

Cancer-shrinking potential

The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.

Imugene MD and CEO Leslie Chong said: “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of advanced solid tumour cancers.

“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential.

“In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform for Australians inflicted with cancer.”

Read more on Proactive Investors AU

Disclaimer

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.