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July 28, 2021

FDA designates Thetis pancreatic cancer treatment ‘orphan drug’ 

Gary Mathias, co-founder and chief executive officer of Thetis Pharmaceuticals. Gary Mathias, co-founder and chief executive officer of Thetis Pharmaceuticals.
By Natalie Missakian

The Food and Drug Administration has designated Thetis Pharmaceuticals' experimental treatment for pancreatic cancer an “orphan drug,” a label that makes the company eligible for tax credits and other financial incentives.

The designation comes as the company gears up for early-stage human testing of the drug, TP-317, at Yale Cancer Center next year.

Thetis describes the drug as a new molecular entity that delivers Resolvin E1, a naturally occurring lipid discovered by researchers at Harvard Medical School. 

It works by targeting inflammation, which is a major cause of cancer progression, metastasis and drug resistance, CEO Gary Mathias said in a statement.  

Preclinical studies at Harvard Medical School have shown Resolvin E1 was effective in suppressing tumor growth in pancreatic cancer, according to the company.

The FDA’s orphan drug designation aims to give financial incentives to companies developing drugs for rare diseases affecting fewer than 200,000 people in the U.S.

The designation makes Thetis eligible for tax credits and fee waivers, and potentially seven years of market exclusivity once the drug is approved.

Pancreatic cancer is the third-leading cause of cancer deaths in the U.S., with a five-year survival rate of just 10%, according to the American Cancer Society.

TP-317  had already earned the orphan drug designation last December for treating ulcerative colitis, a form of inflammatory bowel disease.

The company announced earlier this month that it was expanding its focus from IBD to cancer drugs.

Thetis had been located in Branford before going virtual amid the pandemic. It currently lists its home base as Ridgefield but expects to be back in the New Haven area next year. 

Contact Natalie Missakian at news@newhavenbiz.com

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