Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced 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 Pluvicto^TM (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.