RIDGEFIELD, CT – (August 23, 2021) – Thetis Pharmaceuticals LLC, a privately-held biopharmaceutical company developing Resolvin-based therapies, announced today that the Japanese Patent Office has granted patent JP 6906047 providing composition of matter protection for its lead program TP-317 (Resolvins E1 magnesium lysinate) for solid tumor cancers and inflammatory bowel disease.
“TP-317 is a novel small molecule that represents a highly differentiated approach to regulating immune homeostasis with broad therapeutic potential in cancer and autoimmune diseases,” said Gary Mathias, co-founder and CEO of Thetis. “With long-term patents issued in the U.S., Europe, and Japan, TP-317 has the intellectual property foundation to support clinical development in major markets.”
TP-317 is a new molecular entity that delivers Resolvin E1, a naturally-occurring lipid mediator discovered by biomedical researchers at Harvard Medical School. TP-317 offers a novel approach to reprogram the tumor microenvironment and activate anti-tumor immunity. TP-317 has demonstrated potent single-agent activity in multiple tumor models, and additive effects with chemotherapy and checkpoint inhibitors in cold tumors. Based on this data and a comprehensive safety package, TP-317 is being developed as a once per week subcutaneous injection for solid tumor cancers, including pancreatic and metastatic colorectal cancer.
TP-317 is also being developed as an oral once-per-day therapy for inflammatory bowel disease (IBD) including Crohn’s disease and ulcerative colitis. Based on its unique, non-immunosuppressive mechanism of action, TP-317 is differentiated from approved and current investigational IBD drugs and is targeted at patients with mild-to-moderate IBD before escalation to immunosuppressive biologics and immunomodulators. Phase 1 data indicating that Resolvin E1 is safe and well-tolerated in healthy volunteers have been reviewed by regulatory authorities to support clinical development.
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.
For more information, please visit Thetis Pharmaceuticals’ website (http://thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Senior Director of Business Development