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news.The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for US-based biopharmaceutical firm OncoSynergy's investigational drug candidate OS2966, a neutralizing anti-CD29 monoclonal antibody to treat glioblastoma.
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OS2966 is a first in class therapeutic being evaluated in multiple models of highly aggressive and resistant solid cancers. Glioblastoma is the most common and deadliest primary adult brain tumor.
The drug candidate 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.
The pre-clinical data suggests that OS2966 may be active against numerous solid cancers including recurrent and therapy resistant glioblastoma.
OncoSynergy founder and CEO Shawn Carbonell 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."
The FDA OOPD will help in advancing the development of products for the diagnosis and/or treatment of rare diseases.
OncoSynergy Clinical Development vice-president Anne-Marie Carbonell said the company is happy to achieve this important regulatory milestone and to begin a collaborative relationship with the Agency and the OOPD as it advances OS2966 towards clinical trials.
"Orphan designation is a major step towards expediting this promising therapy to a patient population with few treatment options," Carbonell said.