Fast Track Status Granted by FDA to TRE-515 in Prostate Cancer

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the novel drug, TRE-515, in the treatment of prostate cancer, according to a news release from Trethera Corporation. TRE-515 is currently in Phase 1 clinical trials for solid tumors.

“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 delivering meaningful, long-term benefits to patients.”

The fast track designation applies to the combination of TRE-515 and a radioligand therapy for treating prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), a particularly aggressive form of the disease. PSMA is a key biomarker found in over 80% of prostate cancer cases, making it an important target for earlier diagnosis and more personalized treatment approaches. Fast track is an FDA program designed to help new therapies reach patients sooner, especially when those therapies address serious conditions with limited treatment options.

This designation supports the pairing of TRE-515 with Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radiopharmaceutical already approved by the FDA for PSMA-positive mCRPC that has spread beyond the prostate. This patient group typically includes those whose cancer has progressed after receiving androgen receptor-targeting therapies or taxane-based chemotherapies. Pluvicto delivers radiation directly to cancer cells by linking a PSMA-targeting molecule with a radioactive payload, representing a precision medicine strategy designed to minimize harm to healthy tissues, as per the release.

“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 FDA’s decision follows positive results from Trethera’s first-in-human Phase 1 trial in patients with advanced solid tumors, where TRE-515 demonstrated signs of antitumor activity and a favorable safety profile. The drug is being evaluated as an oral monotherapy in an ongoing dose-escalation study to assess safety, tolerability, pharmacokinetics, and early signs of effectiveness. So far, investigators have increased the dose 18-fold without reaching dose-limiting toxicity, signaling strong potential for further clinical development.

“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 co-invented an FDA-approved PSMA-targeting probe for prostate cancer in 2020.

Prostate cancer remains one of the most commonly diagnosed cancers in men. In the U.S., approximately 285,000 new cases and 35,000 deaths occurred last year alone. For those with metastatic disease, the five-year survival rate is around 30%. Worldwide, nearly 1.5 million men were newly diagnosed in the same period, with 375,000 dying from the disease—underscoring the urgent global need for new treatment options.

“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.

Reference

“FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer." News release. Threthera Corporation.

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