OncoSynergy announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for the investigational drug candidate OS2966, a neutralizing anti-CD29 monoclonal antibody, for the treatment of glioblastoma, the most common and deadliest primary adult brain tumor.
OS2966 is a first in class therapeutic being investigated in multiple models of highly aggressive and resistant solid cancers. OS2966 selectively modulates CD29 (integrin b1 subunit), a critical path driver of multiple mechanisms of tumor growth and progression including proliferation, invasion, angiogenesis, and therapy resistance. Pre-clinical data suggest OS2966 may be active against numerous solid cancers including recurrent and therapy resistant glioblastoma.
"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," commented Dr. W. Shawn Carbonell, MD, PhD, Founder and CEO of OncoSynergy.
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.
"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," said 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."