U.S. Patent Office Issues Trethera Composition of Matter Patent Covering TRE-515, Extending Market Exclusivity to Late 2041
Los Angeles, September 20, 2022 —Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces today that the United States Patent and Trademark Office (USPTO) entered a Notice of Issue for a composition of matter patent covering the polymorphic form of TRE-515. The resulting US patent extends the patent protection for TRE-515 in the United States by at least seven years through November 2041. TRE-515 is a first-in-class drug targeting the enzyme deoxycytidine kinase (dCK) and currently in Phase 1 clinical trials.
“We are extremely pleased with this addition to the TRE-515 patent portfolio,” said Dr. Ken Schultz, Trethera CEO and patent co-inventor. “The patent issue is significant, not only by adding more than 19 years of exclusivity from today in the world’s largest market, but also encompassing claims that cover TRE-515’s unique chemical structure, whether used in the treatment of cancer, multiple sclerosis, or other diseases. Succeeding in this patent application demonstrates Trethera’s strong overall commitment to protecting the innovation and commercialization of our lead asset.”
Trethera is currently enrolling a Phase 1 dose escalation trial to evaluate TRE-515 monotherapy in patients with various solid tumors. Once a day oral doses have escalated from an initial 40mg dose to the current 320mg dose level. As reported in June 2022 and continuing through today, TRE-515 was well tolerated by all enrolled patients with adverse events being transient and manageable. Furthermore, 50% of the patients who completed their second staging CT scan (N=6) in the first two cohorts, meaning 40mg and 80mg dose levels, showed stable disease. The dose escalation portion of the trial is expected to enroll the final patient before year end.
Trethera’s outside intellectual property counsel, Wilson Sonsini Goodrich & Rosati, led the patent prosecution (USPTO number 11,446,307) and similar patent application efforts are underway globally, including the major pharmaceutical markets of Europe and Japan. Trethera’s TRE-515 patent portfolio includes other granted US and global patents and pending applications directed to specialized methods of use for cancer and autoimmune diseases. TRE-515 is a highly selective, potent small molecule inhibitor of the enzyme dCK in nucleotide metabolism.
Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule twice designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.
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