By Michael Philipps
Immunotherapy expert biotech firm Imugene is seeking to put its potentially ground-breaking bowel cancer vaccine known as “PD1-Vaxx” to the test with around 44 patients set to be enrolled in a phase two trial over the next 18 months.
The trial will take place across 6 sites in Australia and another 4 in the UK.
PD1-Vaxx is currently in the development stage of a bid to target colorectal (bowel) cancer and the most common type of lung cancer known as “non-small cell lung cancer” (NSCLC).
Imugene says the primary objective of the trial is to determine major pathological response rates through the measurement of tumour size after treating operable colorectal cancer patients with PD1-Vaxx before surgery that will remove any residual tumour.
Colorectal, or 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.
‘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
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 treatment.
The company says the trials will be partially funded as “investigator-sponsored” studies and would fall within the company’s current cash flow forecasts. Not that money is a problem for Imugene which had $163m in the bank at last report.
Meanwhile Imugene says a European patent for its PD1-Vaxx treatment is now imminent after the European Patent Office last month issued a notification of its intention to grant a patent for it.
The European patent, which covers the manufacturing of the drug and the method of treatment is expected to last until March 28th, 2038 once granted.
Imugene managing director and chief executive officer Leslie Chong said: “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.”
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 colorectal cancer and also lung cancer.
Lung cancer is 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.
Imugene is developing a raft of different anti-cancer treatments and whilst most vary markedly, the company describes itself as an “immunotherapy” company.
In essence Immunotherapy involves removing a patient’s blood or cells and then “reprogramming” them to seek and destroy cancerous cells before re-injecting them back into the body. It is based on the theory that the body’s own inbuilt immune system is best placed to fight diseases like cancer but often is in need of a bit of a boost courtesy of immunotherapy.
Whilst Imugene is not the only biotech out there that has latched onto immunotherapy-based anti-cancer treatments, it is undoubtedly in the vanguard of the cohort. The results of its phase two trials of PD1-Vaxx for bowel cancer will no doubt be highly anticipated by the market that has already marked the company up from its $6m market cap in 2014 to over $800m today.
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).
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