Imugene expects to secure a crucial patent for its “PD1-Vaxx” lung cancer vaccine from the European Patent Office this month, with a trial also set for next year to test the drug’s treatment of colorectal cancer (CRC).
PD1-Vaxx is currently in the development stage of a bid to target non-small cell lung cancer (NSCLC), while with the CRC trial will be run across six sites in Australia and four in the United Kingdom.
Management says the primary objective of the trial is to determine major pathological response rates through the measurement of tumour size, after treating operable CRC cancer patients with PD1-Vaxx before surgery to remove any residual tumour.
CRC, also known as bowel cancer, is the world’s third-most common cancer, with an annual incidence of more than 1.2 million cases and a mortality rate of about 50 per cent.
Last year, an estimated 15,713 new cases of bowel cancer were diagnosed in Australia, affecting 8300 males and 7413 females. It is estimated that a person has a one in 19 (5.2 per cent) risk of being diagnosed with bowel cancer by the age of 85.
Imugene has signed a letter of intent with the University of Southampton in collaboration with Cancer Research UK Southampton Clinical Trials Unit at the Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group to open a phase-two clinical trial for the CRC treatment.
Meanwhile, the European patent application, which covers the manufacturing of the drug and the method of treatment, is expected to proceed to grant by the end of the year. The patent will then have a maximum term that will expire on March 28 in 2038.
Receiving the notice that this European patent application will proceed to grant is an excellent milestone for the technology, and we are excited to continue developing the therapy to demonstrate the value of our PD1-Vaxx vaccine and to have a positive impact on the lives of many cancer patients. Imugene managing director and chief executive officer Leslie Chong
Chong added that the trials would be partially funded as “investigator-sponsored” studies and would fall within the company’s current cash flow forecasts.
Corresponding patent applications for PD1-Vaxx are pending in Canada, China, Hong Kong, India, South Korea, Brazil and Australia, while Imugene has also previously received a notice of grant in the US and Japan.
The company describes its “first-in-class” PD1-Vaxx as a programmed death-1 (PD-1) vaccine designed to treat tumours such as lung cancer. Despite its somewhat ominous name, PD-1 refers to a checkpoint that provides inhibitory signals to the immune system in order to modulate the activity of T cells in peripheral tissues and maintain self-tolerance in the setting of infection and inflammation.
Imugene explains that PD1-Vaxx is designed to produce an effect similar to lung cancer treatments such as “Keytruda” and “Opdivo” and other immune checkpoint inhibitor monoclonal antibodies that are currently transforming medication for a range of cancers.
Globally, lung cancer is the second-most diagnosed cancer and NSCLC is the most common type of lung cancer in the United States, accounting for 81 per cent of all diagnoses.
Lung cancer is also the leading cause of cancer deaths for men and women worldwide. It is estimated that 127,070 deaths (67,160 men and 59,910 women) from the disease will occur in the US this year.
In 2020, an estimated 1,796,144 people died worldwide from the disease.
With both lung and colon cancer impacting the lives of so many people globally, the value of the European patent and upcoming trial for PD1-Vaxx cannot be overstated.
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