Disruptive Innovation for Treating Inflammation and Diabetes — Biotherapeutics, Inc. (BTI) is a science based biotech company dedicated to developing novel, orally bioactive small molecule therapeutics for inflammatory diseases and diabetes.
With 12 exclusive in-licensed patents, BTI’s scientific foundation is anchored on informatics and computer modeling-enabled drug selection and development with significant animal pharmacology validation. Through focused execution, innovative proprietary technology with strong IP and committed leadership, BTI is advancing its expansible product pipeline into clinical development of disruptive treatments with a significant global market opportunity.
BTI has identified Lanthionine Synthetase Cyclase-Like 2 (LANCL2) as a novel therapeutic target for inflammatory diseases and diabetes. Based on extensive preclinical studies, BTI has demonstrated a unique mechanism of action (MOA) that exerts potent anti-inflammatory effects with an encouraging early safety profile. BTI’s lead candidate for inflammatory bowel disease (IBD), BT-11, is supported by strong animal pharmacology proof of concept in three validated animal models of gut inflammation, a promising safety profile and human translational data. BT-11 is a transformative LANCL2-based therapy that addresses a significant unmet clinical need in autoimmune diseases and diabetes, and has the potential to help millions of people worldwide.
Based on these scientific achievements, BTI has been supported by NIH through SBIR/STTR mechanisms, the state of Virginia and CIT. They have recently been recognized by Virginia Governor Terry McAuliffe and Secretary of Commerce and Trade Maurice Jones in the Velocity program with an honorable mention and a $50,000 cash award. The Virginia Velocity business plan competition is part of Governor Terry McAuliffe’s strategy for building a new Virginia economy. The competition was open to all companies in the bioscience and energy sectors, including those based outside of Virginia.
The Virginia Bioscience Health Research Corporation (VBHRC – The Catalyst) has awarded a Phase II project of $400,000 to Biotherapeutics, Virginia Tech and Virginia Commonwealth University to advance BTI’s innovative product pipeline along Investigational new drug approval, clinical testing, and toward commercialization.
Going forward, BTI is anticipating starting human clinical trials with their clinical lead, BT-11, in Crohn’s Disease (CD), a widespread and debilitating disease that afflicts four million people worldwide. The most effective chronic treatments currently available for IBD are injectable anti-TNFa monoclonal antibodies. Treatment is expensive, ~$20,000/year, and has serious adverse side effects. The route of administration is via IV or subcutaneous injection, requiring visits to clinics/surgeries and frequent monitoring.
The use of anti-TNFα antibodies is generally reserved for patients who have failed to respond to other medications such as 5-ASAs and rescue steroids. BTI’s unique LANCL2-based therapy is orally active and is expected to be more effective than anti-TNF monoclonal antibodies without their side effects, with a much lower cost of goods.
BTI’s clinical lead compound for CD, BT-11, is supported by strong animal pharmacology in three validated animal models of gut inflammation, an excellent safety profile in animal studies to-date, and human translational data, suggesting it could be suitable for induction and maintenance of remission for the majority of stages of the disease. Similar oral products for CD such as Celgene’s Mongersen (formerly GED-0301) have been acquired for upfront payments of $710M and are anticipated to total over $1B in global annual net sales. BTI’s innovative pharmacology provides a path for developing an expansible therapeutic pipeline for a wide range of human diseases.
BTI is a spinoff company of Virginia Tech and has called the research park home since its foundation in 2008. BTI is led by Dr. Josep Bassaganya-Riera, President and CEO. Since then, BTI has been advancing disruptive products to treat inflammation and diabetes. The proximity to campus and the excellent facilities offered by the VTCRC and Virginia Tech, as well as the talent and expertise available at the university, provide an outstanding biomedical and translational ecosystem critical for successfully advancing new therapeutics and nutritionals to market.
BTI has recently launched a $20 million fundraising campaign to allow the company to initiate human studies for it lead therapeutic target for Crohn’s disease by 2016. BT-11 is an orally active, locally acting small molecule therapeutic developed by BTI for Crohn’s disease that shows superior efficacy than current and investigational drugs with a benign safety profile.
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