Los Angeles, October 15, 2021 — Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the first patient has been treated with TRE-515, a first-in-class inhibitor of deoxycytidine kinase (dCK). Trethera’s multi-site Phase 1 study will evaluate TRE-515 monotherapy in up to 36 patients with various solid tumors.
“I am thrilled to announce the world’s first clinical stage dCK inhibitor, TRE-515” said Dr. Ken Schultz, Trethera Chairman and CEO. “This study will assess the safety and tolerability of TRE-515, as well as utilize multiple biomarkers to measure target engagement, a valuable tool for predicting antitumor activity in the clinic. We look forward to sharing future updates as the clinical trial progresses.”
“The first patient dosed marks a significant milestone toward delivering on the promise and potential of an exciting new clinical treatment strategy targeting dCK,” said Dr. Michael Shepard, Lasker Laureate and member of the Trethera Scientific Advisory Board. “TRE-515 is a one-of-a-kind small molecule inhibitor that has the potential to durably treat devastating diseases such as cancer and multiple sclerosis.”
Trethera’s US-based clinical trial evaluates the safety and tolerability of TRE-515 in patients with various solid tumor malignancies. A common characteristic of solid tumors is the rapid cellular DNA replication necessary to enable accelerated malignant growth. TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in a nucleotide metabolism pathway shown to be overexpressed in cancer cells. By targeting dCK, scientists hope to selectively and effectively deprive cancer cells of a needed additional source of nucleotides, thereby blocking DNA replication and halting tumor progression.
“For years, Trethera has had an unwavering commitment to advancing nucleotide metabolism treatments,” said Dr. Caius Radu, co-founder and primary inventor. “With the first patient treated in this historic clinical trial, we mark a significant step in advancing the TRE-515 clinical program and move closer to our goal of developing a game-changing medicine for patients with cancer and autoimmune diseases.”
“TRE-515 is intelligently designed and on target, knocking out dCK, which could be a key to stopping the growth of certain tumors or modulating select autoimmune diseases,” said Dr. Owen Witte, co-founder and Scientific Advisory Board member. “Advancing a first-in-class drug from bench to bedside represents a remarkable scientific achievement.”
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 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. 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.
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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.