Singh Biotechnology receives orphan drug designation for STAT3

Release Date: 14-Oct-2016

Food and Drug association, U.S, has granted orphan drug status to SBT-100, developed by Singh Biotechnology, a start-up biotech company. STAT3 has novel anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody (SDAB) SBT100, for the treatment of pancreatic cancer. It can be inhibited either by directly targeting the intracellular protein or indirectly, by targeting the upstream regulators of the STAT3 pathway. Pancreatic cancer is a life threatening disease causing death of almost 95% of all the patients suffering.


Orphan designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The drug also qualifies for financial incentives and tax credits clinical investigation and certain FDA application fee exemption and seven year of market exclusivity on regulatory product approval.


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