The US Food and Drug Administration has stamped Imugene’s “Vaxinia” drug trials aimed at treating bile duct cancer with “fast-track” status, providing the company with a suite of crucial review and approval priorities.
The status designation will allow Imugene to collaborate more closely with the powerful FDA and puts it near the top of the list for future FDA reviews. It relates to the company’s metastatic advanced solid tumours (MAST) clinical program that is assessing the safety, tolerability and efficacy of its cancer-killing Vaxinia virus – which is also known as “CF33-hNIS”.
The FDA awarded Imugene the fast-track status after the company produced a promising data package from its phase-one trials with patients suffering from bile duct cancer – a rare disease where malignant cancer cells form in the bile ducts. Bile duct cancers are known to be difficult to treat and previous medical research has shown they respond poorly to immunotherapy drugs.
Management says the fast-track status has a history of fast-tracking hope for cancer patients.
The Fast Track process of drug development is designed to facilitate the development and the review of drugs to treat serious conditions and fill an unmet medical need, with Fast Track status often leading to earlier drug approval and access by patients. Imugene chief executive officer and managing director Leslie Chong
The company says a key advantage provided by the designation is that it opens the door for regular rolling reviews with the FDA, which can lead to support for a new drug or other biologic license applications.
Imugene chief medical officer Dr Paul Woodard said the company’s work and trials data had already attracted substantial interest from clinicians working with bile duct cancer patients because of its difficult treatment history.
The Vaccinia virus was developed by Professor Yuman Fong at the world-famous, US-based City of Hope, one of that country’s biggest cancer research and treatment organisations. It has a long track record of safe use in millions of humans and was the active component of the vaccine that eventually wiped out one of the most devastating diseases known to humanity – smallpox. It was also the first virus to demonstrate viral cancer-fighting capability in the laboratory in 1922.
The virus has a short and well-understood cycle and spreads rapidly from cell to cell, but does not invade the human genome. It is known to be effective in destroying cancer cells across a wide range of tumour types and has the potential to act as both a gene therapy delivery vehicle and as a tumour-destroying agent.
Imugene’s drug is a combination of gene sequences from multiple Vaccinia virus strains. When CF33 is combined with the “human sodium-iodide symporter” (hNIS) gene, it is called Vaxinia and enables imaging to track the virus in the body to assist radiotherapy targeting.
It has also been shown in preclinical laboratory and animal models to shrink colon, lung, breast, ovarian and pancreatic cancer tumours.
Imugene’s ongoing multicentre MAST trial began with low doses of Vaxinia to patients who have had at least two prior lines of standard of care treatment. The trial aims to recruit cancer patients across about 12 trial sites in the US and Australia. It began in May last year and is expected to run for about two years, with funding from existing budgets and other resources.
Showing the power of the FDA’s imprimatur, the company’s share price jumped more than 31 per cent to hit an intraday trading his of 12 cents, up from yesterday’s close of 9.1c.
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