Traverse Biosciences has signed an exclusive, worldwide license agreement with the Research Foundation for the State University of New York to develop a drug to treat canine periodontal disease.
The potential therapy would fulfill an unmet medical need, as periodontitis affects approximately 80 percent of dogs by the age of three and leads to tooth loss. The drug candidate comes from a discovery by Stony Brook University scientists who have developed a library of proprietary agents designed to treat inflammation.
This technology to treat inflammation is licensed by Traverse Biosciences to commercialize animal health applications of these promising drug candidates with an option to license human health applications. Periodontal disease is not only prevalent in dogs. It remains one of the most widespread human diseases in the world, is the primary cause of tooth loss in adults, and has been associated with chronic conditions such as heart disease, diabetes, and various cancers.
The drug compounds were invented by Lorne Golub, DMD, MD (Honorary), Distinguished Professor in the Department of Oral Biology and Pathology in the Stony Brook University School of Dental Medicine, and Francis Johnson, PhD, President of Chem-Master International Inc. and Professor of Chemistry and Pharmacology at Stony Brook. The partnership with Chem-Master helps to strengthen research of the technology, as expertise in medicinal chemistry is provided by Dr. Johnson and colleagues and biology by Dr. Golub and colleagues.
Traverse's initial focus will be animal health, particularly canine periodontal disease. This offers a lower regulatory hurdle and faster path to market. The company’s lead compound, TRB-N0224, is envisioned as the first FDA‐approved, once‐daily, edible prescription medication for the prevention of canine periodontal disease.
Drs. Golub and Johnson have joined Traverse as scientific co-founders; Peter Donnelly, Director of the Office of Technology Licensing and Industry Relations (OTLIR) at Stony Brook University, has been appointed to represent the Research Foundation as a Board Observer.
“Stony Brook University has a strong history and reputation of research, innovation and entrepreneurship,” says David O. Conover, Vice President of Research at Stony Brook University. “We are happy to work with companies like Traverse Biosciences to ensure that this legacy continues for our faculty, staff, and students, as well in the regional community.”
“This license agreement provides Traverse Biosciences with access to a pipeline of promising drug candidates invented by world-renowned scientists with a significant track record of success,” says Joseph Scaduto, Founder and CEO. “We are excited to work closely with the Research Foundation to rapidly advance this technology towards market, for the benefit of health, society, and the innovation economy.”
The compounds are chemically-modified curcumins, the active ingredient in turmeric. During inflammation, the body produces excessive levels of enzymes that break down collagen and destroy tissue. These enzymes-called matrix metalloproteinases, or MMPs-need zinc at the active site of the enzyme molecule to function properly; the chemically-modified curcumins bind the zinc, normalizing enzyme levels and inhibiting their effect. The novel, multifunctional anti-inflammatory agents also constrain inflammatory “mediators”-biochemical compounds produced by our own body cells that “recruit” inflammatory cells to the site.
“This platform technology builds upon a long history of research, discovery, and drug development, which has the potential to broadly impact a wide variety of veterinary and human health conditions,” says Dr. Golub. “We plan to work closely with Traverse Biosciences as a scientific co-founder to commercialize our MMP inhibitors for the prevention and treatment of a range of chronic inflammatory diseases.”
Earlier in Dr. Golub’s career at Stony Brook, he and colleagues with research support from the NIH and industry, discovered and later developed non-antibiotic properties of tetracycline as inhibitors of MMPs and inflammatory mediators for various diseases. The research ultimately resulted in two FDA-approved drugs, Periostat® (now generic) for periodontitis and Oracea® for the treatment of inflammatory skin condition acne/rosacea.
The Office of Technology Licensing and Industry Relations negotiated the licensing agreement with Traverse. The OTLIR partners with SBU inventors and the business community, helps protect intellectual property, and identifies and works with existing companies and entrepreneurs to license the rights to intellectual property and bring it to market.
“The goal is to then use success in animal health to advance the indications for human health,” says Sean Boykevisch, Assistant Director for Life Sciences in the OTLIR, who led license negotiations on behalf of the Research Foundation. The Centers for Disease Control (CDC) estimates that half of U.S. adults aged 30 years and older have periodontitis; the annual cost of periodontal therapy has been judged to exceed $14 billion in the U.S. alone.
“We look forward to a productive partnership with Traverse Biosciences to develop these chemically-modified curcumins for a variety of therapeutic indications impacting both human and animal health,” Boykevisch says. “The partnership also provides an opportunity to support the growth of a new venture in the region that was specifically launched to commercialize intellectual property invented at Stony Brook University.”
The drugs were developed in concert with the New York State Center for Biotechnology at Stony Brook University. The Center provided financial support to help the inventors develop their lead compound and for follow-on animal studies. It arranged for intellectual property services, helped position the company for more financing, and provided office space.
“The Center for Biotechnology and Stony Brook University are strongly committed to continuing to develop programs aimed at supporting the translation of biomedical science into products that will impact human health,” says Yacov Shamash, Vice President for Economic Development at Stony Brook University. “Support for emerging technologies, not only on the research and development side but also strategic business management, is critically important to the success of new ventures which is what will ultimately lead to new healthcare treatments.”
The Center also recruited Traverse CEO Scaduto as a ‘BioEntrepreneur-in-Residence.’ The BioEntrepreneur-in-Residence program engages entrepreneurs to launch bioscience ventures in the Long Island region based on commercially promising biomedical technologies emerging from Stony Brook University. BioEntrepreneurs-in-Residence develop commercialization strategies, business plans, and investor presentations; negotiate and execute option and/or license agreements with the OTLIR; and seek and secure capital from both public and private sources.
“The execution of the worldwide license agreement between Traverse Biosciences and the Research Foundation marks a significant milestone for the Center’s expanding BioEntrepreneur-on-Residence Program,” says Clinton Rubin, Director of the New York State Center for Biotechnology at Stony Brook University. “This formal transfer of intellectual property demonstrates the commitment Stony Brook University and the Center for Biotechnology have to ensuring the innovation economy and entrepreneurial ecosystem in the region continues to develop, expand and thrive.”
Traverse Biosciences received a $205,709 Phase I Small Business Technology Transfer (STTR) award in partnership with the School of Dental Medicine at Stony Brook University to advance the technology. Funding from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) will help evaluate the effectiveness of the lead drug candidate, TRB‐N0224, for the treatment of periodontal disease. The research will be led by Dr. Golub and Ying Gu, DDS, PhD, Associate Professor in the Department of General Dentistry, who will serve as co‐principle investigators on the award in collaboration with Traverse Biosciences.