• Imugene issued “Intention to Grant” notice by European Patent Office
  • The patent will be given to its PD1-Vaxx cancer vaccine
  • The company will begin PD1-Vaxx Phase 2 colorectal cancer clinical trial in 2024

 

Oncology biotech Imugene (ASX:IMU) rose 7% this morning after releasing a couple of announcements.

The company said that the European Patent Office has issued a notification of “Intention to Grant” for Imugene’s PD1-Vaxx cancer vaccine.

PD1-Vaxx is a first-in-class programmed death-1 (PD1) vaccine, currently in clinical development for non-small cell lung cancer (NSCLC) and in 2024, colorectal cancer.

It was designed to treat tumours such as lung and colorectal cancer by interfering with the PD-1/PD-L1 pathway, and produce an anti-cancer effect similar to Tecentiq, Keytruda and Opdivo.

The European patent application, which covers the manufacturing and method of treatment, is expected to proceed to grant in late 2023.  Once granted, the patent will have a maximum term that will expire on 28 March 2038.

Corresponding applications for PD1-Vaxx are pending in Canada, China, Hong Kong, India, South Korea, Brazil and Australia. The patent has previously received a Notice of Grant in the US and Japan.

“Receiving the notice that this European patent application will proceed to grant is an excellent milestone for the technology,” said Imugene’s CEO, Leslie Chong.

“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.”

 

Phase 2 study to commence in 2024

Meanwhile, Imugene also confirmed the PD1-Vaxx Phase 2 colorectal (CRC) cancer clinical trial will commence in 2024.

Approximately 10 sites – six in Australia and four in the UK – with approximately 44 patients will be enrolled in the study over about 18 months.

The primary objective of the trial is to determine major pathological response rates (a measurement of tumour size), after treating with PD1-Vaxx before surgery to remove any residual tumour.

Colorectal cancer, also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of over 1.2 million cases and a mortality rate of approximately 50%.

It is estimated that a person has a 1 in 19 (or 5.2%) risk of being diagnosed with bowel cancer by the age of 85.

“We are excited to commence this important Phase 2 trial with PD1-Vaxx after being approached by the leading colorectal cancer oncologists from both Australia and the UK,” said Chong.

“The study costs are partially funded being Investigator Sponsored studies, and fall within current cash flow forecasts,” she added.

 

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