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OncoSynergy’s cancer drug OS2966 gets FDA orphan drug status

US-based biotechnology firm OncoSynergy has received orphan drug designation from the FDA's Office of Orphan Products Development (OOPD) for OS2966, a first in class humanized monoclonal antibody, to treat ovarian cancer.

Last year, the company also secured orphan designation for investigational drug candidate to treat glioblastoma.

OS2966 selectively blocks CD29 (integrin b1 subunit), a dominant molecule modulating cell interactions in the tumor microenvironment and plays a major role in the metastatic cascade.

OncoSynergy Clinical Development vice-president Dr Anne-Marie Carbonell said: "Ovarian Cancer is highly aggressive, clinically evasive, and inevitably resistant to current standard of care chemotherapeutic options.

"The FDA’s decision to grant OS2966 Orphan Designation underscores the need for additional therapeutic options and validates the scientific rationale of OncoSynergy’s program."

According to the pre-clinical data, OS2966 may be active against numerous solid cancers including ovarian, brain and breast cancer.

UC San Francisco professor of Medical Oncology Dr Pamela Munster said: "This is an encouraging development for women with ovarian cancer.

"OS2966 has shown great promise in pre-clinical models of metastatic and resistant ovarian cancer including with malignant ascites."