Trethera Awarded $2.3 Million NIH Grant to Study TRE-515 Combined with Radiation Therapy in Prostate Cancer Preclinical Models

LOS ANGELES, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today the award of a new $2.3 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH). The award evaluates Trethera’s lead drug candidate, TRE-515, combined with radiation therapies to treat metastatic castration resistant prostate cancer (mCRPC)— a disease that claims 70% of patients within 5 years of diagnosis. The grant funds testing TRE-515 with standard of care radiation therapy in mCRPC mouse models to inform future clinical trials.

“Securing this NIH grant continues our prostate cancer momentum, coming less than a month after receiving FDA Fast Track designation for the same indication. Such dual validations are rare and substantiate the strength of our scientific rationale and clinical observations,” said Dr. Ken Schultz, Chairman and CEO of Trethera. “Combining TRE-515 with precision-guided radiation therapies, aims to exploit a metabolic vulnerability in prostate cancer cells and extend survival for patients who have few viable options.”

TRE-515 inhibits deoxycytidine kinase (dCK), the key enzyme for the nucleoside salvage pathway that becomes activated and essential for the growth of abnormal cells in autoimmune diseases and cancer. Blocking this pathway deprives cancer cells of the DNA building blocks needed for uncontrolled proliferation. When treated with radiation, cancer cells must gather additional building blocks to repair the radiation-caused DNA damage. Combining radiation with TRE-515 synergistically cripples the ability of cancer cells to recover from DNA damage and enhances the therapeutic response.

Because dCK is relatively conserved in the regulated cell division of healthy cells, inhibiting dCK with TRE-515 has demonstrated a favorable safety profile and clinical benefit in ongoing first-in-human trials. Based on these observations, the NIH award will expand development into additional preclinical prostate cancer models and in combination with radiation therapy. Globally, 1.5 million men are diagnosed with prostate cancer each year with over 40,000 deaths annually. While FDA approved targeted radiation therapies have transformed the mCRPC market, these therapies have a 29.8% response rate, meaning 7 in 10 men experience no clinical benefit from treatment.

Figure 1. Artist interpretation of a growing prostate tumor.

“Prostate cancer remains the second leading cause of cancer related death in men, with limited effective therapies once the disease becomes resistant and metastatic,” said Dr. Michael Shepard, Trethera Scientific Advisory Board member and Lasker Prize Laureate. “A novel, first-in-class drug such as TRE-515, paired with radiation, could redefine treatment for this devastating disease.”

In its written summary, the NIH peer review panel commented, “strong preliminary data supports the premise that TRE-515 is an effective and specific dCK inhibitor… will likely lead to proof of concept that combining TRE-515 with radiation will be an effective approach for preventing resistance… opens new opportunities to apply this inhibitor to a broad range of cancers… has very strong commercial potential… shown to be safe with no toxicity in dose escalation studies.”

Sources: Sartor, N Engl J Med. 2018; 378(7); Siegel, Cancer J Clin. 2023; 73(1); Bunimovich, PLoS One. 2014; 9(8); Rawla, World J Oncol. 2019; 10(2); Pluvicto™ FDA label

Note: Statements taken from the official NIH peer review written summary reflect their personal scientific assessment and are not official NIH endorsements.

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. 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 might also respond to TRE-515 treatment. The FDA has designated TRE-515 a Fast Track drug for prostate cancer and an Orphan Drug for two autoimmune neurologic diseases. 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.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com. You can also follow Trethera on Facebook and LinkedIn.

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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5863b092-8f0b-4c85-a4bd-e783a3c18e90

Figure 1

Artist interpretation of a growing prostate tumor.

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