Foundation funded GBM trial delivers promising Phase 1 results

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A funded Glioblastoma (GBM) clinical trial has shown positive safety and bioimaging results, which took place at Austin Health and the Royal Brisbane Women’s Hospital.

The Phase 1 trial investigated the effects of ifabotuzumab (formerly KB004) on GBM – the most common and deadly form of brain cancer. The promising results were presented at the American Association for Cancer Research (AACR) Annual Meeting, held virtually from April 10 –15 2021.

GBM is the most common and aggressive primary brain cancer in adults, with an average prognosis between 12 and 15 months, and only 5% of people surviving more than 5 years.

Cure Brain Cancer Foundation funded $500,000 towards this trial. The drug ifabotuzumab was manufactured and provided by public U.S. biotechnology company Humanigen.

This encouraging Australian research is led by Associate Professor Hui Gan and Professor Andrew Scott at the Olivia Newton-John Cancer Research Institute and Austin Health in Melbourne, with collaborators including Professor Andrew Boyd and Professor Bryan Day at QIMR Berghofer Medical Research Institute and Dr. Po Inglis from the Royal Brisbane and Women’s Hospital in Brisbane.

Primary Investigator Associate Professor Hui Gan (L) in the lab

Dr. Hui Gan stated, “Establishment and conduct of this trial would not have been possible without the generous support of Cure Brain Cancer Foundation’s funding.  Patients with GBM have few effective treatment options.  This study thus far has demonstrated that KB004 is very specific and is able to move to the cancers within the body, without affecting normal healthy tissue.  This finding is extremely important as it will allow us to explore the clinical benefit by delivering a higher dose as a single agent as well as providing relevant safety information to develop future trials in other drug delivery methods including combination therapies and antibody drug conjugates”.

Dr. Hamza Anwer, Head of Research at Cure Brain Cancer Foundation shared, “We invested $500K into this program in 2014 and have witnessed ongoing optimistic indicators since. We are hopeful the next phase follows this positive trajectory and we see real change for our community. The highly specific nature of ifabotuzumab targeting tumour tissue is exceptionally encouraging. We are proud of Australia’s key involvement in the development of this trial to support the global cancer landscape.”

Background

Ifabotuzumab is a monoclonal antibody that targets a specific protein (EphA3) on the surface of cancer cells and tumour-associated blood vessels (vasculature). EphA3 is present on up to 40% of all GBM cells and 100% of the tumour vasculature, making it an attractive target for immunotherapy. This Phase 1 study aims to determine the safety and tolerability of ifabotuzumab in patients with recurrent GBM, its specificity for cancer cells, and to track its movement around the body using state-of-the-art imaging methods. This approach will help determine the optimal dose for future Phase 2 trials.

Results

Results from the trial demonstrate that ifabotuzumab selectively targets GBM tumour tissue and the tumour microenvironment, whilst preserving healthy brain tissue. Some side-effects were observed and successfully managed with standard supportive measures.

These results offer exciting potential for further clinical trials with ifabotuzumab for patients with glioblastoma and other solid tumours.

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