By GREGORY ZELLER //
When a new U.S. patent is your second-biggest announcement of the day, you’re probably in a good place.
It’s all smiles (with healthy teeth, of course) lately at Stony Brook-based Traverse Biosciences, which on Tuesday announced a new patent and a material transfer agreement with what CEO Joseph Scaduto dubbed “a top-10 global animal-health company” – essentially, an agreement to privately test flagship formula TRB-N0224 against a host of animal illnesses.
That’s in addition to a major canine periodontal disease study slated to start in the coming weeks at Stony Brook University – which, in addition to actually studying TRB-N0224 as a canine treatment, also fulfills a required step toward potential human studies. Traverse Biosciences has selected a vendor to produce an additional 5 kilograms of the TRB-N0224 compound, which Scaduto described as a final step toward the critical SBU study.
The materials agreement, meanwhile, involves an international animal-healthcare provider – Scaduto wouldn’t name names – that will put TRB-N0224 through its paces for six to 12 months, including “their own in vitro and in vivo testing,” Scaduto told Innovate LI.
But while SBU investigators will be concentrating exclusively on canine periodontal disease, research efforts in the new commercial partner’s laboratories will adopt a broader scope.
“What’s really unique and exciting is they will be exploring alternative therapeutic indications in animal health, beyond canine periodontal disease,” Scaduto said.
The new patent, issued Jan. 31 by the U.S. Patent and Trademark Office, covers the use of a proprietary library of chemically modified curcumins (plant-based chemicals) including TRB-N0224.
It’s the third patent involving the drug, which was created by Traverse Biosciences cofounder Lorne Golub and SBU chemistry and pharmacological sciences professor Francis Johnson.
The first patent covered the actual molecular design of TRB-N0224, according to Scaduto, and the second involved potential uses for those molecules. The third focuses on use of the chemically modified curcumins as a treatment for inflammatory diseases including periodontal disease and arthritis – further exclusivity for the in-development TRB-N0224, which has been licensed to Traverse Biosciences by the Research Foundation for the State University of New York.
“It’s expanded coverage and protection in the United States, at least, of the molecules and their novel uses,” Scaduto said. “It’s an increased barrier of entry for competitors to replicate what we’re doing.”
And it’s not likely to be the last. Traverse Biosciences has “a number” of further patents pending domestically and abroad, according to the CEO, “covering various methods of use of these molecules” and “additional potential therapeutic indications for these drug candidates.”
Forecasting when they might come to pass isn’t easy – “It’s very difficult to predict the review process by the U.S. PTO and the European authorities,” Scaduto noted – but the CEO’s best guess suggests new TRB-N0224 patents “probably in 2018.”
The third patent and the new materials agreement come on the heels of a big year for Traverse Biosciences, which in 2016 earned a $1.32 million Phase II Small Business Technology Transfer Award from the National Institutes of Health, shared with the SBU School of Dental Medicine, to fund that canine periodontitis study; a $500,000 seed investment from Rochester-based venture-capital firm Excell Partners; and a $164,689 Department of Defense stipend, shared with SUNY Upstate Medical University, to explore the drug as a potential treatment for serious lung injuries.
The company in 2016 also completed a successful pilot study pitting Golub and Johnson’s creation against non-naturally occurring periodontitis in a laboratory beagle, clearing the way for the coming canine periodontal studies.
With the SBU study, the new materials agreement and other clinical tests covering multiple potential verticals moving ahead, Traverse Biosciences will continue to doggedly protect its potential wonder drug, according to its CEO.
“We’re always collaborating with our academic partners to identify new areas of patentability,” Scaduto said. “We want to continue to create those barriers of entry for competitors, and to extend the patent life covering these molecules.”