FDA Allows Fast-Track Status Of Therapy from Australian Pharmaceutical For Rare Type Of Cancer


An Australian pharmaceutical company has achieved a significant milestone in the battle against bile duct cancer, securing fast-track status from the United States Food and Drug Administration (FDA) for clinical trials of a promising cancer treatment.

This rare form of cancer has proven resistant to conventional and immunotherapy treatments, promoting the exploration of innovative approaches. The Australian company, Imugene, in collaboration with the renowned US-based City of Hope, has developed a new iteration of an existing treatment that has demonstrated exceptional promise in early trials.

City of Hope, a globally recognized cancer research and treatment organization based in Los Angeles, initiative the groundbreaking phase 1 safety trial in May of the previous year.

Principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research, Daneng Li, M.D., said, “Our previous research demonstrated that oncolytic viruses can stimulate the immune system to respond to and kill cancer, as well as stimulate the immune system to be more responsive to other immunotherapies, including checkpoint inhibitors.”

In this trial, the first patient was administered a low dose of an oncolytic virus – a virus designed to infect and destroy cancer cells. The engineered virus, developed by Professor Yuman Fong, has now been licensed by City of Hope to Imugene for use in their cancer treatment, known as Vaxinia.

The technical nomenclature for this treatment is “CF33-hNIS,” with CF33 representing the virus and hNIS denoting an additional chemical that facilitates imaging and tracking of the virus. This capability allows for the precise application of radiochemotherapy, enhancing treatment accuracy.

Bile duct cancer is a rare malignancy occurring both inside and outside the liver, with only an average of 8,000 new diagnoses annually in the United States. Traditional treatment options have shown limited efficacy against this challenging cancer type.

The oncolytic virus, originally engineered by Professor Fong, has a well-understood lifecycle that does not involve integration with the human genome. Its unique attributes include the ability to deliver tumor-destroying agents while also reducing the size of tumors.

City of Hope conducted preliminary trials of the oncolytic virus in animals and cultured cells, demonstrated its effectiveness in shrinking tumors associated with colon, lung, breast, ovarian, and pancreatic cancers.

According to the West Australian, Imugene’s FDA-guided clinical trial, named the MAST (metastatic advanced solid tumors) trial, commenced with administrating low doses of Vaxinia to patients who had undergone at least two prior lines of standard-of-care treatment.

The fast-track status granted by the FDA is a testament to the potential impact of Imugene’s innovative approach. This designation will facilitate closer collaboration between the company and the FDA, expediting data reviews for future developments.

Both Imugene and City of Hope are actively seeking to recruit eligible patients for the MAST trial at 12 different sites across the United States and Australia.