Trethera News

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Trethera Successfully Completes Enrollment of Phase 1 Dose Escalation Trial for Patients with Solid Tumors

September 10, 2025

Trethera has completed enrollment of its Phase 1 dose escalation trial for TRE-515 in solid tumors. Doses increased 36-fold without dose-limiting toxicities, and early clinical benefit was observed. Data will be presented at an upcoming scientific conference.

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Trethera Awarded $2.3 Million NIH Grant to Study TRE-515 Combined with Radiation Therapy in Prostate Cancer Preclinical Models

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August 26, 2025

Trethera has been awarded a $2.3M NIH SBIR grant to evaluate TRE‑515 in combination with radiation therapy against mCRPC in preclinical models—building on its recent FDA Fast Track designation and reinforcing its drug candidate’s therapeutic rationale.

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Trethera Awarded $3 Million NIH Grant to Advance First-In-Class Drug, TRE-515, for the Treatment of Lupus

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August 19, 2025

Trethera has been awarded a $3M NIH SBIR grant to advance TRE‑515 for the treatment of systemic lupus erythematosus (lupus). The funding supports toxicology, pharmacology, and efficacy studies in preclinical models, paving the way toward future clinical trials.

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FDA Provides Trethera Clearance to Initiate TRE-515 Clinical Trial in Healthy Volunteers to Study Food Effect and Biomarkers

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July 30, 2025

The FDA has cleared Trethera's TRE‑515 clinical trial in healthy volunteers to study food effects and key biomarkers like deoxycytidine (dC), supporting precision dosing and enriched biomarker datasets.

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FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer

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July 9, 2025

The FDA granted Fast Track designation to TRE‑515 in combination with precision-guided radiation therapy for metastatic castration-resistant prostate cancer (mCRPC), supporting accelerated development in one of the most aggressive forms of prostate cancer.

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