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A&G Pharmaceutical Receives Phase II SBIR Grant to Develop PGx Breast Cancer Drug, Companion Test

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A&G Pharmaceutical has received $1.2 million in Phase II Small Business Innovation Research funding from the National Cancer Institute for its development of a personalized breast cancer treatment.

The SBIR grant will go toward A&G's “Novel Targeted Therapy for Breast Cancer" program, under which A&G plans to develop a therapeutic antibody against the cancer-associated protein GP88. As previously reported by PGx Reporter sister publication ProteoMonitor, A&G has been internally working on developing a diagnostic and drug combination treatment targeting GP88 since the early part of the decade (PM 03/18/05).

Clinical studies suggest that overexpression of the GP88 protein can identify more than 80 percent of breast cancer patients, who are more likely to develop chemoresistance, metastasis, and experience cancer cell growth. Comparatively, overexpression of HER2 accounts for around 25 percent of breast cancer patients.

According to a statement from the Columbia, Md.-based personalized medicine company, currently no marketed therapeutics or diagnostics on the market interrogate GP88. However, A&G is hoping to fill this market opportunity.

"A&G Pharmaceutical is embracing the FDA call for personalized medicines," said CEO Ginette Serrero in a statement. However, A&G has been planning to take the GP88 marker through FDA since 2005, when the Serrero first publicly discussed plans to meet with the agency to garner clearance for a biopsy-staining GP88 test (PGx Reporter 03/17/05).

While A&G is in the process of developing a GP88-targeting drug, on the diagnostics side, the company is validating two assays: the OncoStain 88 tissue test and the Onco 88 blood test. These tests, which measure GP88 levels in patients’ biological samples, will serve as the companion tests to the investigational drug in development.

The company said that it has used its tissue test in human clinical trials to demonstrate that an increased expression or presence of GP88 in tumor tissue of breast cancer patients is associated with an increased risk of recurrence as well as decreased overall survival. It added that a GP88 blood test is being studied in ongoing prospective trials in breast cancer patients.

In addition to the SBIR funding, revenues from A&G’s Precision Antibody service division, which provides customized antibodies to federal labs and pharma and biotech firms, will support the company's drug-development efforts.

The GP88-targeting Rx/Dx breast cancer treatment is A&G's lead product. However, according to the company's website, A&G also plans to extend the GP88 program into lung cancer.

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