Trethera Receives FDA Approval To Initiate TRE-515 Phase 1 Clinical Trial in Solid Tumors Monotherapy
Los Angeles, April 19, 2021— Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its TRE-515 investigational new drug (IND) application for the treatment of solid tumor malignancies. Trethera will now begin the site activation process with the University of Los Angeles (UCLA) as well as other US based sites where health innovation is a key focus.
“Receiving regulatory approval to initiate a phase 1, first-in-human clinical trial with an innovative, first-in-class oral inhibitor of deoxycytidine kinase (dCK), the key enzyme in the nucleotide salvage pathway, is a landmark clinical development. It adds another potential weapon to our therapeutic arsenal against solid tumors,” said Dr. Zev Wainberg, UCLA Professor of Medicine, and Co-Director of the GI Oncology Program, and Director Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. “We are especially excited that this protocol includes advanced diagnostics that will enable us to readily measure the drug impact on malignant progression.” Dr. Wainberg will be the principal investigator for the trial that will enroll cancer patients with a wide range of solid tumors.
The Phase I open-label, dose escalation study is expected to enroll the first patient in the final quarter of 2021. The overall goal will be to evaluate safety, pharmacokinetics, and establish a recommended phase 1b/2 starting dose. The protocol includes measuring deoxycytidine (dC), the dCK substrate, as well as utilizing a specialized PET probe to measure intracellular dCK as the drug target. “As multiple tumor types upregulate dCK in response to increased DNA synthesis needs, TRE-515 has the potential for multi-tumor anticancer activity alone, or in combination with other established or developing therapeutics,“ said Dr. Ken Schultz, Trethera Chairman and CEO.
Trethera is a preclinical 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 designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class preclinical 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. Certain autoimmune diseases might 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 cells or autoimmune diseases that will transform outcomes for patients.
Note on Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.