Imugene receives DIR licence for VAXINIA Phase 1 trial expansion in Australia

September 21, 2022 10:23 AM AEST | By Manisha
Follow us on Google News:


  • Imugene Limited has secured the DIR licence, essential for expanding its VAXINIA Phase 1 clinical trial within Australia.
  • The licence has been granted by the Australian Government’s Office of the Gene Technology Regulator (OGTR).
  • The clinical trial started in May this year and is likely to conclude in around 24 months.

Imugene Limited (ASX:IMU), an eminent player marking transformational progress in cancer treatment, has been granted the DIR licence by the Australian Government’s Office of the Gene Technology Regulator (OGTR). The licence holds prominence for expansion of the company’s VAXINIA Phase 1 clinical trial within Australia. It is an essential element needed for the Australian regulatory framework for matters relating to the intentional release of organisms which are genetically modified into the environment.

The licence is titled ‘Clinical Trial of a Genetically Modified (GM) Chimeric Orthopoxvirus (CF33-hNIS) as a Cancer Treatment’.

An overview of Phase 1 VAXINIA trial

Image Source: Company Announcement

Imugene’s Phase 1 VAXINIA clinical trial is titled “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).”

The company initiated the multicenter Phase 1 VAXINIA trial in May this year at its sites based in the United States. A total of 100 patients will be enrolled for the study across 10 clinical trial sites in Australia and the United States.

In preclinical laboratory as well as animal models, City of Hope-developed oncolytic virus, CF33-hNIS VAXINIA, has been shown to shrink breast, colon, lung, ovarian, and pancreatic cancer tumours. As of now, a low dose of VAXINIA has been delivered to the enrolled subjects having metastatic or advanced solid tumours. All the recruited patients have had at least two prior lines of the standard of care treatment.

The study is expected to be conducted for a period of around two years.

Image Source: ©2022 Kalkine Media®, Data Source: Company Announcement

IMU shares were trading at AU$0.220 on 21 September 2022.


The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (Kalkine Media, we or us), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.

Top ASX Listed Companies

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK