By GREGORY ZELLER //
First, healthy teeth for dogs … then a cancer cure for the world?
Financially and otherwise, Traverse Biosciences enjoyed a strong 2016 – but it may ultimately pale compared to what’s shaping up as a potentially enormous 2017 for the Stony Brook biotech and its flagship pharmaceutical. Fueled primarily by a $1.32 million Phase II Small Business Technology Transfer award granted by the National Institutes of Health in August to the company and the Stony Brook University School of Dental Medicine, Traverse is in the final stages of selecting a manufacturer to produce about 5 kilograms of TRB-N0224, a patented compound that may prove to be an unparalleled elixir for human and animal periodontal diseases.
Co-created by Traverse Biosciences co-founder Lorne Golub, TRB-N0224 – which may also prove effective against a host of human and animal inflammatory diseases and even some forms of cancer – is still “a ways away” from human clinical trials, noted Traverse Biosciences CEO Joseph Scaduto. But work funded by the Phase II STTR grant is actually a double-impact blessing for Traverse’s R&D efforts, Scaduto noted, advancing both the human and animal developmental lines.
“In fact, we focused on animal health indications – namely canine periodontal disease – for a reason,” Scaduto told Innovate LI. “The pre-clinical model for the human disease is the dog. So we’re getting a nice bang for the buck with this grant, which allows us to do a dog study both as a target species for our animal-health vertical and as the pre-clinical efficacy model for a human study.”
The 2017 experiments, slated to begin in the first quarter of the New Year, were set up by another significant 2016 achievement: the completion of pilot studies matching TRB-N0224 against a ligature-induced periodontitis (that is, not naturally occurring) in a laboratory beagle.
In essence, the NIH is funding what Scaduto called a “follow-on study” that evaluates the drug in beagles with naturally occurring periodontitis, “a more clinically relevant model of the disease.”
The NIH funding wasn’t the only positive financial development of 2016 for Traverse Biosciences. In June, Traverse announced it had a received a key $500,000 seed investment from Rochester-based early-stage venture-capital firm Excell Partners, money Scaduto said would accelerate TRB-N0224’s development and “expand the company’s product-development pipeline.”
And in July, Traverse Biosciences was selected to share a $164,689 Department of Defense stipend with SUNY Upstate Medical University, a grant that would fund early laboratory testing of TRB-N0224 as a potential treatment for serious lung injuries.
The Phase II SBTT grant, meanwhile, is already generating additional outside interest, boding well for Traverse Bioscience’s scientific and financial prospects. Scaduto said the grant has “triggered interest by three of the top 10 global animal-health companies,” who like TRB-N0224’s potential as a periodontal treatment for both companion animals and livestock.
Scaduto said he’s “cautiously optimistic” that at least one of those major companies “will choose to work with us on the commercialization of this technology for animal health,” suggesting a deal could possibly be struck over the first half of the New Year.
“We’ve been focused on responding to their requests for information on data generated by our molecules to date,” he noted. “It’s highly likely one of them will be interested in partnering with us.”
The likelihood of such a partnership should be strengthened in the coming weeks, when Traverse Biosciences officially receives its latest U.S. patent. Scaduto said Wednesday his 2013 startup received a Notice of Allowance this week from the U.S. Patent and Trademark Office, indicating that a new patent – Traverse’s third – would be issued “within the month.”
The new exclusivity will cover various methods of using TRB-N0224 to treat “a variety of inflammatory diseases, including periodontal disease,” according to Scaduto. It will join existing patents covering the proprietary compound’s chemical structure and its use as a possible cancer treatment.
The flagship formula’s cancer-fighting potential is the focus of ongoing collaborations at the Feinstein Institute for Medical Research, Northwell Health’s R&D division, and the Albert Einstein College of Medicine in the Bronx. Early studies of TRB-N0224’s effectiveness against certain forms of pediatric cancers are showing “positive results,” according to Scaduto, more reason for the CEO and his team to be optimistic heading into 2017.
“These studies build on work that was previously conducted at Stony Brook University, along with published work on cancer stem cells and unpublished work on pancreatic cancer,” Scaduto said. “We’re actually building a pretty strong body of evidence that our drug candidates are effective against a variety of cancers.”
As it looks to break new ground in the New Year, Traverse Biosciences will stick to familiar methods. His company is “constantly applying for grants,” Scaduto noted, and will continue to go with business and R&D models that have worked so far.
“Our strategy, as always, will be to collaborate with animal researchers on animal models of a disease, gather preliminary data and leverage that data to attract grant money and strategic partners,” the CEO said. “We’re always exploring potential therapeutic indications that would allow us to add to our business model.”