Trethera Receives $2 Million National Cancer Institute Grant for Advancement of Clinically Relevant Biomarkers in Phase 1 Trial

LOS ANGELES, May 30, 2023 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a $2 million Small Business Innovative Research (“SBIR”) grant from the National Cancer Institute (“NCI”). The grant will fund additional patient dosing studies to identify predictive biomarkers of activity and target engagement of TRE-515 in solid tumors. Trethera’s lead asset, TRE-515, is a first-in-class deoxycytidine kinase (“dCK”) inhibitor.

"We are honored to receive this highly competitive SBIR grant that supports additional clinical advancement and compelling opportunities for TRE-515," said Dr. Ken Schultz, principal investigator and Trethera CEO. "This grant allows further biomarker evaluations, helping to inform patient selection and dosing in order to target multiple types of difficult to treat cancers."

The NCI grant follows favorable results announced earlier this year from Trethera’s Phase 1a clinical trial in high risk, heavily pretreated patients with solid tumor malignancies. In the all comers designed (i.e., unselected) dose escalation trial, TRE-515 demonstrated a superb safety profile while also showing antitumor activity for 1 in 4 patients.

Two pancreatic cancer patients with baseline PET scans detecting dCK activity inside tumor cells, showing focally high (Patient A) and low (Patient B) activity

Dr. Tim Donahue, Trethera Board member and UCLA Chief of Surgical Oncology, commented, "With this funding, we intend to further showcase the therapeutic promise of disrupting nucleoside salvage pathway activity with TRE-515 as a late line therapy in solid tumors. We look forward to advancing TRE-515 through Phase 2 with the prospect of helping patients in need."

“The preliminary biomarker data support the underlying TRE-515 mechanism as an on-target dCK inhibitor that expects to positively impact disease progression in patients with solid tumors,” stated Dr. Jean DeKernion, Trethera Board member and UCLA Professor Emeritus of Urology. “A direct Phase 2 NCI award is incredibly competitive and a significant mark of distinction.”

A discussion summary from the panel of NCI experts that reviewed Trethera’s proposal stated, “the drug development plan is state of the art…noted efficacy in stabilizing disease progression in more than one patient in the early phase clinical trial…preliminary studies indicate that this assay can be validated…dCK represents an important and novel therapeutic target.”

TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway. A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division. In contrast, dCK activity is not required in most healthy adult human cells. Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

About Trethera

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 administered 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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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.

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