Doorway into Europe opens for Imugene with PD1-Vaxx cancer vaccine patent grant imminent

Imugene (ASX: IMU) has achieved another significant international approval milestone with the company receiving notification from the European Patent Office that the grant of a patent for its PD1-Vaxx cancer vaccine is imminent.

The company has also announced plans for a new set of trials in the UK and Australia. Official granting of the new patent to the Australian clinical stage immuno-oncology company is expected by year-end.

Imugene’s unique treatment 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 (CRC).

The patent application covers the manufacturing and method of treatment and once granted, the patent will have a maximum term that will expire on 28 March 2038.

Patents being sought in multiple jurisdictions

Imugene’s chief executive officer and managing director Leslie Chong said corresponding applications 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 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,” Ms Chong said.

Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung and colorectal cancer by interfering with PD-1/PD-L1 (ligand 1) binding and interaction to produce an anti-cancer effect similar to Tecentiq, Keytruda, Opdivo and other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Imugene’s unique platform of technologies enhances the body’s immune system in its fight against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies.

Phase 2 trial to open in UK and Australia

In related news, Imugene has confirmed it has signed a letter of intent to undertake a phase 2 clinical trial in the UK under which the PD1-Vaxx vaccine will be evaluated for patients diagnosed with operable CRC.

The agreements have been reached 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 (AGITG).

Dr Tony Dhillon, based at the Royal Surrey Hospital NHS Foundation Trust, has been named as the chief investigator for the trials in collaboration with the University of Southampton, UK and co-chief investigator professor Timothy Price from the Queen Elizabeth Hospital in Adelaide, South Australia.

Dr Dhillon said this will be a  potentially groundbreaking trial using a vaccine to PD-1 in MSI High early colorectal cancer.

“Professor Price, Imugene and I have been working on the trial design and are thrilled to finally see sites set up in the UK and Australia. We are grateful to the University of Southampton Clinical trials Unit, who are running the trial and the AGTIG, who have been involved from the beginning.”

The primary objective of the study is to determine the pathological response rates, while the secondary objectives are to assess the safety of PD1-Vaxx, evaluate biomarkers and evaluate the objective response rates and overall survival.

Ms Chong said this important phase 2 trial with PD1-Vaxx is being undertaken after Imugene was approached by the leading CRC oncologists from both Australia and the UK.

Global cancer issue

CRC, 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%.

In 2022, an estimated 15,713 new cases of bowel cancer were diagnosed in Australia. 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.

The standard of care treatment for locally-advanced CRC is neoadjuvant (before surgery) chemotherapy and surgical resection of the colon or rectum.