Novel Cancer Biomarker
“Unfortunately, more than 40% of such women are not responsive or become nonresponders to these treatments,” says Ginette Serrero, Ph.D., CEO, A&G Pharmaceutical. “There is an unmet need to identify protein-based biomarkers for anti-estrogen resistance to be run alongside tests used in the standard of care that could better predict who will and who won’t respond to treatment.”
A&G Pharmaceutical has identified one such biomarker called GP88. “This is an autocrine growth and survival factor produced, secreted, and absolutely required by the cancer cells. A&G has performed studies demonstrating that this biomarker plays a critical role in cancer development, invasiveness, and for the survival of breast and lung cancer.
“We have developed two diagnostic kits that measure GP88 in tumor tissue and in serum of patients. The tissue test has been validated in two independent clinical trials. These demonstrated that in ER+ breast cancer patients, an elevated GP88 was correlated with a fourfold increase in the risk of disease progression. Further, ongoing prospective clinical studies have found that serum GP88 levels are elevated in breast and lung cancer patients as compared to healthy subjects.”
Dr. Serrero also described the company’s development of a companion therapeutic. “We have developed a neutralizing monoclonal antibody against GP88 that is undergoing preclinical development. Our studies include mouse xenograft models of tamoxifen resistance. We found that when used together, the monoclonal antibody potentiated tamoxifen response.”
Leading investigators in the field suggest that within the next five years, oncologists and their patients will have many more therapeutic options. Perhaps as many as 25 molecularly targeted agents for cancer therapy will be available.
Within this time frame, virtually every possible mutation will have been identified in the genomes of the most common cancers. This will allow increasingly effective monitoring of the treatments for cancer by examining robust biomarkers from samples obtained by minimally invasive means.