RIDGEFIELD, CT – (July 28, 2021) – Thetis Pharmaceuticals (“Thetis”), a leading developer of Resolvin-based therapies for cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to TP-317 for treatment of pancreatic cancer.
“TP-317 is a first-in-class Resolvin E1 therapy that offers a transformative new approach to treating solid tumors by targeting pro-tumor inflammation, which is a major cause of cancer progression, metastasis and resistance.” said Gary Mathias, CEO of Thetis. “This Orphan Drug designation is based on the pioneering research of Dr. Dipak Panigrahy at Harvard Medical School demonstrating the robust single-agent efficacy of Resolvin E1 in suppressing tumor growth in multiple models of pancreatic cancer. We anticipate initiation of clinical studies of TP-317 in 2022.”
Eileen O’Reilly, MD, Winthrop Rockefeller Endowed Chair in Medical Oncology and co-Director for Medical Initiatives at the David M. Rubenstein Center for Pancreatic Cancer at Memorial Sloan Kettering Cancer Center (MSK) and a member of Thetis’ scientific advisory board (SAB) commented, “Pancreatic cancer is the fourth leading cause of cancer-related mortality worldwide and has an overall five-year survival rate of nine percent. Although the use of multi-agent cytotoxic combinations has improved outcomes for advanced pancreatic cancer, overall survival for most patients is less than a year. Thus, new therapeutic options are needed. Based on encouraging preclinical efficacy data and its differentiated mechanism of action addressing pro-tumor inflammation, TP-317 could offer a major benefit as adjuvant to existing standard of care and as monotherapy in the maintenance setting.”
The FDA’s Orphan Drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions, in part defined as affecting fewer than 200,000 people in the United States. Sponsors of designated orphan drugs are eligible for tax credits for clinical trial costs, waiver of the user fee for marketing applications and, upon approval, consideration for seven years of marketing exclusivity.
TP-317 is a patent-protected new molecular entity that delivers Resolvin E1 (RvE1), a naturally-occurring lipid mediator discovered by biomedical researchers at Harvard Medical School. Research from the Panigrahy Lab published in the Journal of Experimental Medicine demonstrates that Resolvins suppress tumor growth by reprogramming the tumor microenvironment to clear tumor cell debris and reduce secretion of pro-tumor cytokines. Recent preclinical studies conducted at the Panigrahy Lab demonstrate that TP-317 has additive effects with chemotherapy and immunotherapy in pancreatic cancer models.
About Pancreatic Cancer
Pancreatic cancer is a lethal disease that accounts for 3.2% of cancer cases in the U.S. (57,600 in 2020) but contributes to 8% of cancer deaths (47,050 in 2020), making it the fourth leading cause of cancer-related mortality in the United States. With incidence and mortality rising, pancreatic cancer is expected to become the 2nd leading cause of cancer death in Western countries by 2030. Due to the lack of symptoms during the early stages of disease and ineffective screening, 80-90% of U.S. patients with pancreatic cancer are diagnosed late in their disease with non-resectable locally advanced or metastatic disease that have 5-year survival rates of 12% and 3%, respectively.
The primary treatments for pancreatic cancer include surgery for the 10-20% of newly diagnosed patients with early-stage disease and systemic chemotherapy for the 80-90% of patients newly diagnosed with non-resectable disease. Thus, improving treatment of non-resectable pancreatic cancer has become one of the most urgent needs in cancer medicine.
About Thetis Pharmaceuticals
Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and autoimmune diseases. Thetis’ proprietary HEALER™ technology platform enables the pharmaceutical development of Resolvins, a class of endogenous lipid mediators that regulate immune homeostasis by resolving inflammation and clearing cell debris. Thetis’ HEALER™ technology overcomes the stability, manufacturing, and formulation hurdles that have limited the development of Resolvins as pharmaceutical agents, unlocking their robust pharmacology to be developed as first-in-class small molecule drugs.
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding Thetis’ expectations regarding the development and the continued progress of Thetis’ programs, including the intended incentives conferred by orphan-drug designation, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, the anticipated benefits of our HEALER platform, the expected safety profile of our product candidates, timing and likelihood of success of our current or future product candidates, and the market opportunity for our product candidates. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Actual results could differ from those projected in any forward-looking statements due to numerous factors, including, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, including our ability to recruit and enroll patients in our studies; our ability to address the requests of the U.S. Food and Drug Administration; competition in the industry in which we operate; and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
TP-317 is an investigational drug product that has not been approved by the U.S. Food and Drug Administration. Dr. O’Reilly is a paid consultant for Thetis.
For more information, please visit Thetis’ website (http://thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Senior Director of Business Development