Navigation Links
Singh Biotechnology Receives Second FDA Orphan Drug Designation for its Novel Single Domain Antibody for the Treatment of Osteosarcoma by Targeting Intracellular STAT3
Date:10/11/2017

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) for the treatment of osteosarcoma. SBT-100 is able to cross the cell membrane and bind intracellular STAT3 and inhibit its function. Dysregulation of STAT3 activity has been implicated in the development of many malignancies including osteosarcoma. Many studies have shown that STAT3 expression and survival of human tumors is coupled with elevated STAT3 expression and associated with a poor prognosis of many solid tumors, including osteosarcoma. Due to stagnation in survival rate under current standard of care, innovative drugs and approaches to treating osteosarcoma are needed.

“Since the STAT3 pathway plays an important role in development of osteosarcoma and represents a new potential therapeutic target, developing anti-STAT3 therapeutics for osteosarcoma is essential to treating this disease,” said Sunanda Singh, M.D., Ph.D., Founder & President/Chief Executive Officer of Singh Biotechnology. "We believe, SBT-100, our single domain antibody represents a promising new approach for a targeted immuno-therapy in the treatment of osteosarcomas since it represents a first-in-class therapeutic which specifically targets intracellular proteins." STAT3 can be inhibited either by directly targeting the protein or indirectly, by targeting the upstream regulators of the STAT3 pathway. In vitro and in vivo models of tumor growth and metastasis have shown that targeting STAT3 activation via inhibitors is a promising treatment for cancer. Singh Biotechnology is developing SBT-100, a sdAb to STAT3 to provide a novel treatment option for patients with osteosarcoma as an effective and alternative treatment over the currently available options of surgery, radiation therapy, and chemotherapy.

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 osteosarcoma. To this end Singh Biotechnology has developed an anti-STAT3 single domain antibody that binds specifically to the intracellular STAT3 protein for the treatment of osteosarcoma. Currently there are no STAT3 inhibitors available clinically to help treat patients.

About Osteosarcoma
Osteosarcoma is an aggressive rare disease defined by the presence of malignant mesenchymal bone forming cells depositing immature bone matrix. With an annual incidence rate of only 3.1 cases per million in the US, it is considered a rare disease. Although the survival of patients with osteosarcoma has improved with the introduction of chemotherapy, the rates have since plateaued. The 5-year survival rate of patients with high grade osteosarcoma is 60-66% but is dependent on stage at diagnosis. Patients with localized disease have a 5-year survival rate as high as 60-78%, however the rate is only 20-30% for those with metastatic disease. In addition, older adults diagnosed with osteosarcoma have shown a decreased response and toleration to chemotherapy leading to a poor prognosis. Recurrent disease level reduces the 5-year survival rate to 20%. 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 osteosarcoma in patients over the currently available options of surgery, radiation therapy, and chemotherapy.

About Singh Biotechnology
Singh Biotechnology (SBT) is a start-up biotech organization established in 2014 which discovers and develops unique and proprietary therapeutic single domain antibodies (sdAbs) for the treatment of a variety of cancers, autoimmune and ophthalmic diseases by leveraging its novel technology platform. Using this technology platform, SBT has been able to generate therapeutic sdAbs that specifically target intracellular molecules of interest, which play an important role in the pathogenesis of these diseases. Currently SBT is at the pre-IND stage for triple negative breast cancer (TNBC) and is targeting to file an IND in early 2018. In addition, SBT has several concurrent scientific programs in various stages of pre-clinical development for oncology, autoimmune, and ophthalmic diseases. On August 29th, 2016 Singh Biotechnology’s SBT-100 was granted orphan drug designation for the treatment of pancreatic cancer.

Singh Biotechnology is a privately held company headquartered in Tampa Bay, Florida. For additional information visit: http://www.singhbiotechnology.com

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

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

Read the full story at http://www.prweb.com/releases/2017/10/prweb14784505.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. Dr. Singh and Apollonia Dental Launches Ground-Breaking Cavity Prevention Program That Can Lower Decay Rates by 74%
2. Lycera Appoints Harinder Singh, Ph.D., as Chair of Scientific Advisory Board
3. The Journal of Allergy and Clinical Immunology Publishes Phase 2a Study Results With Cytos Biotechnologys CYT003 for the Treatment of Allergic Asthma
4. The BioVoyage Institute Now Offering Hands-On Training Programs For Biotechnology Products & Applications
5. Animal Biotechnology 2013 Market Report
6. The BioVoyage Institute is seeking the help of corporations, organizations, institutions, communities and individuals to help with bioscience and biotechnology education
7. UMBC Cybersecurity and Biotechnology Programs Hold April 24 Information Session at Shady Grove Campus
8. San Diego State University Hosts Open House for Life Science Immersion Biotechnology Program
9. Plandai Biotechnology, Inc. Updates Progress Of Preparing Products For Market
10. Global Biotechnology Industry Market Research Report Now Available from IBISWorld
11. NanoSight, One of the UKs Fastest Growing Biotechnology Companies, Wins a 2013 Queens Award for Enterprise - Innovation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... 12, 2017 , ... DuPont Pioneer and recently formed CasZyme, ... into a multiyear collaboration to identify and characterize novel CRISPR-Cas nucleases. The goal ... editing across all applications. , Under the terms of the agreement, Pioneer will ...
(Date:10/12/2017)... ... October 12, 2017 , ... BioMedGPS announces expanded ... of its newest module, US Hemostats & Sealants. , SmartTRAK’s US Market for ... fibrin sealants, synthetic sealants and biologic sealants used in surgical applications. BioMedGPS estimates ...
(Date:10/12/2017)... CA (PRWEB) , ... October ... ... (https://www.onramp.bio/ ) has launched Rosalind™, the first-ever genomics analysis platform specifically designed ... bioinformatics complexity. Named in honor of pioneering researcher Rosalind Franklin, who made ...
(Date:10/11/2017)... , ... October 11, 2017 , ... ... gene in its endogenous context, enabling overexpression experiments and avoiding the use of ... small RNA guides is transformative for performing systematic gain-of-function studies. , This ...
Breaking Biology Technology:
(Date:4/5/2017)...  The Allen Institute for Cell Science today announces ... portal and dynamic digital window into the human cell. ... application of deep learning to create predictive models of ... a growing suite of powerful tools. The Allen Cell ... publicly available resources created and shared by the Allen ...
(Date:4/4/2017)... , April 4, 2017   EyeLock LLC ... announced that the United States Patent and Trademark Office ... broadly covers the linking of an iris image with ... transaction) and represents the company,s 45 th issued ... patent is very timely given the multi-modal biometric capabilities ...
(Date:3/30/2017)... March 30, 2017 The research team of ... three-dimensional (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae ... realm of speed and accuracy for use in identification, crime investigation, ... cost. ... A research ...
Breaking Biology News(10 mins):