TRE-5151 Receives FDA Fast Track Designation in Combination With Radiation Therapy for Prostate Cancer

The FDA has granted fast track designation to TRE-515 (Trethera Corporation), a novel drug, in combination with radiation therapy for the treatment of prostate cancer. Specifically, the treatment is indicated for an advanced type of prostate cancer, known as prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), that can be treated by combining TRE-515 with lutetium Lu 177 vipivotide tetraxetan (Pluvicto; Novartis), a radiopharmaceutical that was approved by the FDA in March 2022.¹

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“This designation marks a critical milestone in our mission to develop more effective, well-tolerated therapies for aggressive and treatment-resistant prostate cancers,” Ken Schultz, chairman and CEO of Trethera, said in a news release. “By combining TRE-515 with targeted radioligand therapy, we seek to accelerate precision medicine, going beyond current standards of care and delivering meaningful, long-term benefits to patients.”¹

Signs and Symptoms of Prostate Cancer

Prostate cancer is one of the most common types of cancer, which accounted for nearly 285,000 new cases and caused 35,000 related deaths last year in the United States. The cancer is usually found in its early stages and takes time to progress. Early-stage symptoms include blood in the urine, blood in the semen, needing to urinate more often, trouble getting started when trying to urinate, and waking up to urinate more often at night.²

Once in the metastatic stage, individuals have a 30% chance of surviving 5 years and could experience symptoms of accidental leaking of urine, back pain, bone pain, erectile dysfunction, feeling very tired, losing weight without trying, and weakness in the arms or legs.²

“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,” Johannes Czernin, Trethera cofounder and professor of nuclear medicine at UCLA, said in the news release. “The TRE-515 FDA designation offers continued hope to the mCRPC community.”

TRE-515 Combined With a Radiopharmaceutical

As a precision cancer treatment designed for adults with PSMA-positive mCRPC, lutetium Lu 177 vipivotide tetraxetan is used after individuals have undergone other treatments like androgen receptor pathway inhibition and taxane-based chemotherapy. The treatment works by combining a targeting compound with a therapeutic radioisotope. Once administered, the therapy binds to prostate cancer cells that express PSMA. The radioisotope then emits energy, damaging these target cells and nearby cells, ultimately causing cell death.

“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,” Jean DeKernion, Trethera director emeritus and cofounder of the Specialized Program of Research Excellence (SPORE) in prostate cancer at UCLA, said in the news release.¹

Ongoing Clinical Trial Data for TRE-515

The fast-track designation was supported based on results from the first-in-human ongoing phase 1 trial, along with growing preclinical data that is assessing the use of TRE-515 as an oral monotherapy in adults with advanced solid tumors, focusing on its safety, tolerability, pharmacokinetics, and preliminary efficacy. In the study, the researchers noted that initial results have demonstrated early signs of antitumor activity with a favorable safety profile among individuals treated with TRE-515. This includes an 18-fold dose escalation without limiting toxicities.¹

“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,” Michael Jung, distinguished UCLA professor of chemistry and biochemistry, said in the news release. “The chemical structure of TRE-515 was designed for a specific, on-target binding to create an optimal drug profile.”¹

REFERENCES

1. FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer. Trethera. News release. July 9, 2025. Accessed July 10, 2025. https://www.globenewswire.com/news-release/2025/07/09/3112644/0/en/FDA-Grants-Fast-Track-Designation-for-TRE-515-in-Combination-with-Radiation-Therapy-for-the-Treatment-of-Metastatic-Castration-Resistant-Prostate-Cancer.html

2. Mayo Clinic. Prostate Cancer. News release. February 20, 2025. https://www.mayoclinic.org/diseases-conditions/prostate-cancer/symptoms-causes/syc-20353087