A&G Pharmaceutical has been awarded a two-year, $870,000 grant from the Avon Foundation to further develop its technology for detecting and monitoring breast cancer, the company said last week.
The award was one of 12 granted by the foundation as part of its Breast Cancer Prevention Research Initiative, and the first given to a private company.
A&G will use the money to conduct clinical tests for its proprietary breast cancer biomarker, GP88, in blood and tissue samples in breast cancer patients.
A&G, which calls itself a theranostics company, is in the process of putting together trials in three sites in the mid-Atlantic region involving more than 300 patients diagnosed with the disease, Ginette Serrero, co-founder, president and CEO of the company, told ProteoMonitor this week.
She said the company has already developed a blood-based test that has been in trials for its ability to monitor breast cancer. Now the company wants to see whether GP88 can be used for the early detection of the disease. In addition to measuring levels of the biomarker in blood, the next round of tests will measure its level in tissue.
The goal of the company, Serrero said, is to develop both a laboratory-based diagnostic test and therapeutic for breast cancer based on the GP88 biomarker.
“So [GP88 will be] for the coming years, the 21st century, what HER2 has been previously, in the past 20 years,” she said, referring to the gene that has been associated with a particularly deadly form of breast cancer.
Serrero discovered GP88 while she was working at the now-defunct W. Alton Jones Cell Science Center in upstate New York, and the University of Maryland. An autocrine growth factor produced by breast cancer cells, the protein has also been found to be responsible for the development of malignant drug-resistant cancer, according to the company’s website.
In pre-clinical studies, inhibition of GP88 expression has been shown to suppress breast cancer cell growth and make the cells hormone-resistant.
A&G joins a growing list of companies working to improve on mammograms, the current standard of care in breast cancer detection. By most accounts, mammograms have performed comparatively well, reducing breast cancer mortality by an estimated 35 percent in women aged 50 and older, and by at least 25 percent in women between ages 40 and 50.
“So [GP88 will be] for the coming years, the 21st century, what HER2 has been previously, in the past 20 years.”
But results can show up as false positives and false negatives, and in addition to mammograms, other steps such as breast self-examination, and in some cases ultrasounds and MRI scans are suggested for early detection.
Along with A&G, other companies developing breast cancer tests include Power3 Medical Products, which in October launched a blood-based cancer test in the Middle East [see PM 10/18/07]. Biomarker Technologies and Digilab BioVision are also working on their own tests.
In a statement announcing the award, Carol Kurzig, executive director of the Avon Foundation, cited the 1.2 million new cases projected to be diagnosed this year, and the need for a tool for early detection, which she called “a major worldwide challenge.”
The GP88 technology, she said, “has the potential to detect breast cancer cells at the earliest stage of the disease.”
In the statement, Serrero said the goal of A&G is to establish GP88 “as the most sensitive and reliable marker for early breast cancer detection.”
The Avon award will provide the bulk of the funds needed for the next phase of testing, Serrero said. A $100,000 National Cancer Institute Small Business Innovation Research grant, as well as a Maryland Industrial Partnerships grant for the same amount helped fund the first round of tests.
To date, the company has been sustained largely through private-equity funding totaling $14 million. However, the company’s sole source of revenue at this point comes from its custom antibody production services business. Serrero declined to provide any revenue figures. One of the customers of its antibody service is the National Institutes of Health, she said.
In addition to GP88, A&G, formed in 2000 and based in Columbia, Md., has two other potential biomarkers: one for colon cancer and one for lung cancer. Research into those biomarkers is in the pre-clinical stage, though the company hopes to develop diagnostic tests based on them, Serrero said.
It has also licensed a small molecule for rheumatoid arthritis from the University of Maryland that it plans to develop into a therapeutic. The company’s lead technology is GP88, however, and its future lies in its ability to develop it into a commercial product.
“This is how I developed the protein, meaning … I went looking for a protein that the cell required and expressed, so that you could develop therapeutics as well as diagnostics,” Serrero said.