Melbourne, Australia, February 21, 2012—The Ludwig Institute for Cancer Research (LICR) today announced that the first-in-patient trial with the monoclonal antibody ABT-806i is underway at Austin Health in Melbourne. ABT-806i was created from the monoclonal antibody mAb806, which was generated and characterised by LICR, and later successfully licensed to Abbott through Life Science Pharmaceuticals (LSP).
The Phase 1 study is sponsored by Abbott and is designed to evaluate the biodistribution and pharmacokinetic properties of the humanised antibody ABT-806i, using state-of-the-art imaging technology and expertise from the LICR Melbourne-Austin Branch.
The study will evaluate the uptake of the ABT-806i antibody in tumour and normal tissues. “Data from the trial will help define dosing strategies for ABT-806, and may also enable us to predict who might be more likely to respond to treatment,” said Professor Andrew Scott, LICR Melbourne-Branch Director.
Preclinical studies with the antibody have shown its ability to bind to cancer cells, but not to cells of normal tissue. ABT-806 targets the Epidermal Growth Factor Receptor (EGFR), a protein that is over-expressed by some of the most common tumour types. In vivo studies have also demonstrated that the antibody can cause significant reduction in tumour growth. “We believe this antibody may prove to have significant benefit to patients with a broad array of cancer types, including brain, lung, head and neck, skin and colorectal cancers, with minimal side effects,” added Professor Scott.
Dr. Hui Gan, Chief Investigator for the trial said “To date other EGFR treatments have side effects for patients, such as diarrhoea and severe acne-type skin rashes. We are excited by the potential of this trial and are optimistic that, with further testing, ABT-806 will ultimately become a safer and less toxic therapeutic option for those living with cancer,” said Dr. Gan.
The trial is expected to take around 12 months to complete, and will be conducted at Austin Health and the Peter MacCallum Cancer Centre in Melbourne, and the Royal Brisbane and Women’s Hospital in Brisbane. ABT-806 is currently being evaluated in a Phase 1 study in the U.S.
Background on mAb806
MAb806 does not target normal cells, but selectively targets the EGFR cell surface protein when it is over-expressed on cancer cells, which occurs in more than 50 percent of some types of cancers. Current therapies that target EGFR cause side-effects because they also interact with EGFR when it is present in usual amounts on normal cells.
MAb806 is an antibody that was generated and characterized by LICR scientists. The development of the antibody was the result of a long-term collaboration between the Melbourne-Austin, Melbourne-Parkville, New York and San Diego Branches of LICR.
“The fruitful collaboration between LICR, LSP, the pharmaceutical company Abbott, and Austin Health has highlighted the strength of integrated concerted approaches to science and medicine and the ability of Australian science to be translated to the global stage,” said Professor Scott.
Professor Scott has led the development team over the last 10 years and was instrumental in bringing the antibody from laboratory research through to the “first-in-patient” clinical trials in Australia.
About the Ludwig Institute for Cancer Research
LICR is an international non-profit organization committed to improving the understanding and control of cancer through integrated laboratory and clinical discovery. Leveraging its worldwide network of investigators and the ability to sponsor and conduct its own clinical trials, the Institute is actively engaged in translating its discoveries into applications for human benefit. Since its establishment in 1971, the Institute has expended more than $1.5 billion on cancer research.
LICR is also a partner of the Olivia Newton-John Cancer and Wellness Centre at Austin Health, which has a focus on the development of innovative cancer therapies, and providing quality of life to patients with cancer.