The Imugene Limited (ASX: IMU) share price is shooting higher on Monday morning.
At the time of writing, Imugene shares are up 4.54% to 23 cents.
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What's driving Imugene shares higher?
Investors are bidding up the Imugene share price after the company advised it received a DIR licence for its novel cancer-killing virus, CF33-hNIS (Vaxinia).
Granted by the Australian Government's Office of the Gene Technology Regulator (OGTR), the licence allows Imugene to expand its Vaxinia phase 1 clinical trial within Australia.
A DIR is a dealing involving the intentional release of genetically modified organisms (GMOs). The regulator sets out the conditions under which such dealings must be undertaken when a DIR licence is approved.
In May 2022, Imugene's Vaxinia trial commenced across the US, delivering a low dose of CF33-hNIS to patients with metastatic or advanced solid tumours and who had at least two prior lines of standard of care treatment.
The oncolytic virus, developed by City of Hope, has shown to shrink solid tumours in preclinical laboratory and animal trials.
These tumours include colon, lung, breast, ovarian and pancreatic cancers.
City of Hope is one of the largest cancer research and treatment organizations in the United States.
The study aims to recruit 100 patients across approximately 10 sites in the United States and Australia.
The trial is anticipated to run for approximately 24 months and will be funded from Imugene's existing cash reserves.
Commenting on being granted the licence, Imugene managing director and CEO, Leslie Chong said:
We're pleased to see this regulatory hurdle cleared on schedule which will allow the smooth progression of our VAXINIA Phase 1 trial as planned.
Imugene share price summary
Despite today's gain, it has been a disappointing 12 months for Imugene investors, with the company's share price falling more than 50%.
Imugene presides a market capitalisation of approximately $1.29 billion.
