OncoSynergy's Antibody For Glioblastoma Awarded FDA Orphan Status

Biopharmaceutical company OncoSynergy announced that it has received Orphan Drug designation for its experimental monoclonal antibody OS2966 for the treatment of glioblastoma from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

OS2966 is a novel therapeutic neutralizing anti-CD29 monoclonal antibody being developed in several models of aggressive and resistant solid cancers. The antibody selectively regulates CD29 which plays a key role as a path driver of mechanisms that result in tumor growth and spread. These include proliferation, angiogenesis, drug resistance, and invasion.

The company said preclinical findings suggest that the investigational antibody may exhibit activity against solid cancers including recurrent and resistant glioblastoma.

Dr. W. Shawn Carbonell, Founder and CEO of OncoSynergy, said, “The FDA's decision to grant orphan drug designation highlights the promise of our program and the dire unmet need in glioblastoma where median survival is a mere 15 months despite maximal current therapy.”

Dr. Anne-Marie Carbonell, VP of Clinical Development for OncoSynergy, said, “We are pleased to achieve this important regulatory milestone and to begin a collaborative relationship with the Agency and the OOPD as we advance OS2966 towards clinical trials.” Dr. Carbonell added that the orphan designation will speed the delivery of the treatment to patient populations limited with few therapy choices.

Glioblastoma multiforme is an aggressive, malignant brain tumor responsible for 15 percent of all brain tumors. More than 22,000 patients in the U.S. were diagnosed with the disease in 2010, with over 13,000 estimated to have ended in fatal outcomes from brain cancers. According to the National Health Institutes, there are currently no effective treatments for the disease, which has a poor prognosis of less than 15 months after diagnosis.

Last year, the company entered into collaboration with CMC Biologics for the development and manufacture of the necessary materials for OS2966. The agreement was made to accomplish toxicology studies and Phase I clinical trials to push the investigational therapeutic towards an Investigation New Drug application.