FDA Grants Orphan Drug Designation To OS2966 In The Treatment Of Ovarian Cancer

SAN FRANCISCO, Jan. 21, 2015 /PRNewswire-iReach/ -- 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 also received orphan designation for glioblastoma last summer.

OncoSynergy is a biotechnology startup spun out of UCSF with a vision of addressing dire unmet medical needs, particularly orphan cancers.

OS2966 is a first in class humanized monoclonal antibody that selectively blocks CD29 (integrin b1 subunit), a critical path driver of cancer and therapy resistance. CD29 is the dominant molecule modulating cell interactions in the tumor microenvironment and plays a central role in the metastatic cascade. Pre-clinical data suggest OS2966 may be active against numerous solid cancers including ovarian, brain, and breast cancer.

"Ovarian Cancer is highly aggressive, clinically evasive, and inevitably resistant to current standard of care chemotherapeutic options," commented Dr. Anne-Marie Carbonell, MD, Vice President of Clinical Development for OncoSynergy. "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."

The FDA Orphan Drug Designation program provides incentives for sponsors to develop medicines that address rare diseases and disorders that might otherwise be overlooked.

"This is an encouraging development for women with ovarian cancer," said Dr. Pamela Munster, MD, Professor of Medical Oncology at UC San Francisco. "OS2966 has shown great promise in pre-clinical models of metastatic and resistant ovarian cancer including with malignant ascites. Malignant ascites often causes challenging symptoms and leaves many women with poor qualify of life. Any treatment addressing ascites would provide an enormous benefit on well-being in a patient with ovarian cancer."

About OncoSynergy OncoSynergy is a UCSF spinoff based in San Francisco, California focused on addressing grave unmet needs in medicine with its S.M.A.R.T targeted therapies (multi-indication drug candidates which combat therapeutic resistance). OS2966 is under development for the treatment of aggressive solid cancers and Ebola virus disease. To learn more, visit www.oncosynergy.com.

Photo - http://photos.prnewswire.com/prnh/20150120/170157

Media Contact:Shawn Carbonell, OncoSynergy, Inc., 415-666-2391, shawn@oncosynergy.com

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SOURCE OncoSynergy, Inc.

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