FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer
LOS ANGELES, July 09, 2025 (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 its novel drug, TRE-515, in the treatment of prostate cancer. TRE-515 is currently in phase 1 clinical trials for solid tumors.
The Fast Track designation applies to TRE-515 in combination with radioligand therapy for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer (mCRPC), a condition impacting thousands of patients. PSMA, an important disease biomarker, is detected in over 80% of prostate cancer cases, enabling earlier identification and intervention.
The FDA’s Fast Track program is designed to accelerate the development of promising drug candidates that treat serious diseases with high unmet medical needs. “This designation marks a critical milestone in our mission to develop more effective, well-tolerated therapies for aggressive and treatment-resistant prostate cancers,” said Dr. Ken Schultz, Chairman and CEO of Trethera. “By combining TRE-515 with targeted radioligand therapy, we seek to accelerate precision medicine going beyond current standards of care and deliver meaningful, long-term benefits to patients.”
The designation covers the treatment of a type of advanced prostate cancer referred to as PSMA-positive mCRPC that has spread to other parts of the body (metastatic) by combining TRE-515 with PluvictoTM (lutetium Lu 177 vipivotide tetraxetan), an FDA approved radiopharmaceutical. Eligible patients include those previously treated with other drugs such as androgen receptor pathway inhibitors or taxane-based chemotherapies. Pluvicto combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle), supporting a precision medicine approach.
“I believe that TRE-515 has the potential to make a meaningful difference in the lives of prostate cancer patients and I am pleased that Trethera has received this Fast Track designation to expedite development,” said Dr. Michael Jung, Distinguished UCLA Professor of Chemistry & Biochemistry. “The chemical structure of TRE-515 was designed for a specific, on-target, binding to create an optimal drug profile.” Dr. Jung is a Trethera cofounder, TRE-515 inventor, and discoverer of the FDA approved prostate cancer drugs Xtandi and Erleada, which together generated $9 billion in global sales last year.
Approximately 285,000 new cases of prostate cancer and 35,000 prostate cancer related deaths occurred in the United States last year. Patients with metastatic prostate cancer have an approximate 30% chance of surviving five years, underscoring the high need for new treatments for these patients. Globally, approximately 1.5 million men were first diagnosed with prostate cancer last year and 375,000 succumbed to their disease.
“Prostate cancer is the second leading cause of cancer related death in men. Although the treatment landscape continues to evolve, there is a high unmet need for additional precision medicine treatments and intelligently paired combination therapies to improve patient outcomes,” said Dr. Johannes Czernin, Trethera cofounder and Professor of Nuclear Medicine at UCLA. “The TRE-515 FDA designation offers continued hope to the mCRPC community.” Dr. Czernin coinvented an FDA approved PSMA targeting probe for prostate cancer in 2020.
The FDA’s Fast Track decision was supported by encouraging results from Trethera’s first-in-human Phase 1 trial in cancer patients as well as a growing body of preclinical data, including findings presented at the American Association for Cancer Research annual meeting. The ongoing multicenter Phase 1 dose-escalation study is evaluating TRE-515 as an oral monotherapy in adults with advanced solid tumors, assessing safety, tolerability, pharmacokinetics, and preliminary efficacy. TRE-515 has demonstrated early signs of antitumor activity with a favorable safety profile, including an 18-fold dose escalation without limiting toxicities.
Figure 1. Artist interpretation of a growing prostate tumor.
“Trethera is working closely with the FDA to accelerate development and reimagine cancer care by combining radioligand therapy with TRE-515 to extend the lives of patients with prostate cancer and elevate current standards of care,” said Dr. Jean DeKernion, Trethera Director Emeritus and cofounder of the Specialized Program of Research Excellence (SPORE) in Prostate Cancer at UCLA.
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 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.
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.
About Fast Track Designation
Fast Track is an FDA program intended to facilitate the development and expedite the review of drug candidates treating serious medical conditions with unmet needs. Based on an efficacy-driven assessment by the FDA, a Fast Track drug candidate may be eligible for:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
- More frequent written communication with FDA;
- Accelerated Approval and Priority Review, if relevant criteria are met;
- Rolling submission of a New Drug Application for review by FDA.
About PluvictoTM
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy). It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death. Pluvicto received FDA approval in 2022 and had over $1 billion in sales last year.
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/ab57878f-6fa8-4978-8f60-05ee39a8f3df
Figure 1
Artist interpretation of a growing prostate tumor
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