FDA Grants Second Orphan Drug Designation for OS2966

By March 17, 2015news

SAN FRANCISCO, California, January 20, 2015. 

OncoSynergy announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for OS2966 in the treatment of ovarian cancer. The investigational drug candidate, a neutralizing anti-CD29 monoclonal antibody, received orphan designation for glioblastoma last summer.

OS2966 is a first in class therapeutic candidate that selectively blocks CD29 (integrin β1 subunit), a critical path driver of cancer and therapy resistance. Pre-clinical data suggest OS2966 may be active against numerous solid cancers including ovarian, brain, and breast cancer.

“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,” commented Dr. Anne-Marie Carbonell, MD, Vice President of Clinical Development for OncoSynergy. “Orphan designation is a major step towards expediting this promising therapy to a patient population with few treatment options.”

The mission of the FDA OOPD is to advance the development of products for the diagnosis and/or treatment of rare diseases.  By providing incentives to sponsors the program has successfully enabled development of greater than 400 drugs and biologics for rare diseases since 1983.

“This is an encouraging development for patients with ovarian cancer,” said Dr. Pamela Munster, MD, Professor of Medical Oncology at UCSF. “OS2966 has shown great promise in pre-clinical models of metastatic and resistant ovarian cancer including malignant ascites.”

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