FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of Non-Small Cell Lung Cancer

LOS ANGELES, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for TRE-515 in combination with KRAS inhibitors for the treatment of G12C mutation-positive non-small cell lung cancer (NSCLC) previously treated with an anti-PD-(L)1 antibody and platinum-based chemotherapy.

Lung cancer remains the leading cause of cancer-related mortality worldwide, with more than 2.5 million new cases and 1.8 million deaths globally. NSCLC accounts for approximately 80% of lung cancer deaths. While KRAS inhibitors (KRASi) have created a major advance for patients whose tumors harbor KRAS G12C mutations, response rates remain limited and many responding patients later experience relapse.

“Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies,” said Dr. Ken Schultz, Trethera Chairman and CEO. “KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges. We believe TRE-515 has the potential to address a key metabolic escape pathway used by cancer cells and improve outcomes for patients with this devastating disease.”

TRE-515 inhibits deoxycytidine kinase (dCK), the key enzyme in the nucleoside salvage pathway, which can become activated and essential for abnormal cell growth in cancer. TRE-515 has demonstrated favorable safety and antitumor activity in an ongoing first-in-human trial. Trethera’s approach is based on the observation that KRASi-treated tumors may increase reliance on the salvage pathway as a metabolic support system under therapeutic stress. In preclinical studies, specialized PET imaging showed persistent dCK activity following KRASi treatment, while subsequent TRE-515 treatment completely blocked tumor dCK activity, providing a visual demonstration of the biological rationale for the drug combination (Figure 1).

“For decades, oncology has focused heavily on targeting oncogenic signaling pathways, including KRAS,” said Dr. Owen Witte, UCLA Professor and Trethera co-founder. “The next frontier is understanding how cancer cells adapt metabolically to survive those therapies. If successful, TRE-515 could represent a first-in-class approach by targeting the nucleoside salvage pathway, a key metabolic support system that tumors may use under therapeutic stress.”

The FDA Fast Track decision builds on Trethera’s $2.7 million NIH grant awarded in 2025 to evaluate TRE-515 with KRASi therapies and marks the second FDA Fast Track designation, following its prior designation in metastatic castration-resistant prostate cancer. Fast Track status is intended to facilitate development and expedite review for drugs addressing serious conditions with unmet medical need, including potential eligibility for more frequent FDA communication, Accelerated Approval, and Priority Review if relevant criteria are met.

“For patients with advanced NSCLC, the central challenge is not only achieving an initial response but also making that response more durable,” said Dr. Evan Abt, UCLA Assistant Professor and co-investigator for the preclinical studies. “This Fast Track designation underscores the importance of rapidly evaluating innovative, rational combination strategies that may extend the benefit of KRAS-targeted therapies to more patients.”

Figure 1: Specialized [¹⁸F]CFA PET radiotracer showing persistent dCK activity in a tumor-bearing mouse following KRASi treatment (left), followed by complete blockade of tumor dCK activity after TRE-515 treatment (right).

Sources: Siegel, CA Cancer J Clin. 2024; 74(1); Clark PM, Nucleotides Nucleic Acids. 2026;45(11); Hong, N Engl J Med. 2020; 383(13); Thandra, Contemp Oncol. 2021; 25(1); Lumakras™ and Krazati™ FDA labels.

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 and lung 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 in cancer and autoimmune diseases, with the goal of transforming 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 additional 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; 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/c3aa4ba0-9915-400d-be04-2e6974e9cbf0

Figure 1:

Specialized [18F]CFA PET radiotracer showing persistent dCK activity in a tumor-bearing mouse following KRASi treatment (left), followed by complete blockade of tumor dCK activity after TRE-515 treatment (right).