USF Research News

Drug Start-Up Singh Biotechnology Earns FDA Orphan Drug Designation for Pancreatic Cancer Treatment

November 1, 2016

Tampa Bay Technology Incubator company seeks more effective treatment for cancer

TAMPA, Fla. – The U.S. Food and Drug Administration has granted Singh Biotechnology, LLC (SBT), an orphan drug designation for 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.

"SBT-100, our single domain antibody, represents a new approach for a targeted immuno-therapy in the treatment of pancreatic cancers and represents a first-in-class therapeutic which specifically targets intracellular proteins," said Sunanda Singh, M.D., Ph.D., the founder and Chief Executive Officer of Singh Biotechnology.

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 targeting the upstream regulators of the STAT3 pathway.

Pancreatic cancer has a very poor prognosis with a five year survival rate of only 7.2 percent. More than 95 percent of pancreatic cancer patients die of their disease, largely due to the advanced state at which they are diagnosed.

"Patients with pancreatic cancer have a poor prognosis so there's a clear need for better treatment options,” Singh said. “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.

Singh Biotechnology joined the University of South Florida’s Tampa Bay Technology Incubator (TBTI) in 2015 to assist with pre-clinical research and to utilize the incubator’s state of the art wet lab and critical research equipment. TBTI, part of USF CONNECT, supports technology research as a catalyst for economic development and facilitates the growth and development of life science and other high tech companies.

Singh Biotechnology was established in 2014 to discover and develop 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 late 2017. Singh Biotechnology is a privately held company headquartered in Tampa, Florida.

For additional information visit: www.singhbiotechnology.com.

SBT Contacts:
Sunanda Singh, M.D., Ph.D.
Founder & CEO
Singh Biotechnology
ssingh@singhbiotechnology.com

Ashutosh Parihar
Vice President Research & Development
Singh Biotechnology
aparihar@singhbiotechnology.com

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Media Contact: Laurie Sullivan, 813-974-7245, laura75@usf.edu