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Singh Biotechnology Receives FDA Orphan Drug Designation for its Novel Single Domain Antibody for Treatment of Pancreatic Cancer

Singh Biotechnology
Posted on: 23 Sep 16

Singh Biotechnology today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody (sdAb) SBT-100 for the treatment of pancreatic cancer. Many studies have found that elevated STAT3 expression is associated with a poor prognosis of solid tumors, including tumor of the pancreas. STAT3 can be inhibited either by directly targeting the intracellular protein or indirectly, by targeting the upstream regulators of the STAT3 pathway.

"We believe, SBT-100, our single domain antibody represents a promising new approach for a targeted immuno-therapy in the treatment of pancreatic cancers since it represents a first-in-class therapeutic which specifically targets intracellular proteins," said Sunanda Singh, M.D., Ph.D., Founder and Chief Executive Officer of Singh Biotechnology. "Patients with pancreatic cancer have a poor prognosis so there's a clear need for better treatment options, especially since no new medical advancements have been made in over 20 years. We are extremely encouraged by the fact we have made a tremendous progress in a short time to develop a single domain antibody therapeutic which can potentially deliver a highly targeted compound that can improve the quality of patient’s lives."

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. For a drug to qualify for orphan drug designation both the drug and the disease must meet certain criteria specified in the Orphan Drug Act (ODA) and FDA's implementing regulations at 21 CFR Part 316. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

About STAT3
Impairment in the regulation of STAT3 activity has been implicated in the development of many malignancies, including pancreatic cancer. In vitro and in vivo models of tumor growth and metastasis have shown that targeting STAT3 activation via inhibitors could be beneficial in tackling this disease. Therefore Singh Biotechnology has developed an anti-STAT3 single domain antibody that binds specifically to the intracellular STAT3 protein for the treatment of pancreatic cancer.

About Pancreatic Cancer
Pancreatic cancer has a very poor prognosis with a 5-year survival rate of only 7.2%. More than 95% of patients affected eventually die of their disease. Although several factors are responsible for this, the most important is the advanced stage at which patients are diagnosed. Coupled with the poor diagnosis, only 20% of patients eligible for initial surgical resection. The tumor biology of pancreatic cancer is such that even after surgery, the disease recurs, metastasizes and becomes resistant to both chemotherapy and radiation therapy, with patients ultimately succumbing to the disease. Therefore, there is an unmet clinical need and incentive for developing more suitable and specific anti-STAT3 inhibitors that can provide an effective and alternative treatment of pancreatic cancer in patients over the currently available options of surgery, chemotherapy and radiation therapy.

About Singh Biotechnology
Singh Biotechnology (SBT) is a start-up biotech organization established in 2014 which is in the business of discovering and developing unique and proprietary therapeutic single domain antibodies (sdAbs) for the treatment of a variety of cancers, autoimmune and ophthalmic diseases by leveraging our novel technology platform. Using this technology platform, SBT has been able to generate therapeutic sdAbs that specifically target intracellular molecules of interest, which are mutated, over expressed, or play an important role in the pathogenesis of disease(s). Currently SBT has one pre-IND stage program for triple negative breast cancer (TNBC) and several programs in various stages of pre-clinical development for inflammatory bowel disease (IBD), age-related macular degeneration (ADM), rheumatoid arthritis (RA), psoriasis, prostate cancer, acute myeloid leukemia (AML), sarcoma, and glioblastoma. SBT is targeting to file an IND for TNBC in early 2017. Singh Biotechnology is a privately held company headquartered in Tampa, Florida. For additional information visit:

Sunanda Singh, M.D., Ph.D.
Founder & CEO
Singh Biotechnology

Ashutosh Parihar
Vice President Research & Development
Singh Biotechnology

For more information:

Editor's Details

Mike Wood

Last updated on: 23/09/2016

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