Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) on Thursday said the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application for Telomir-Zn, allowing the company to begin clinical testing in patients with advanced or metastatic triple-negative breast cancer (TNBC).



The clearance marks a key milestone for the clinical-stage biotech as it moves its lead candidate into human trials, targeting epigenetic and metabolic drivers of cancer progression.



<h2>IND Package Supports Clinical Advancement</h2>



Supporting data featured preclinical studies demonstrating activity in TNBC models, along with pharmacokinetic findings showing systemic exposure.



The company also completed IND-enabling toxicology and pharmacology evaluations ahead of the filing.



<h2>Telomir Phase 1/2 Trial Design And Objectives</h2>



The planned Phase 1/2 TELO-001 study will assess Telomir-Zn as an oral monotherapy in adults with advanced or metastatic TNBC who have previously received systemic treatment.



Telomir plans to initiate the Phase 1/2 trial in the first half of 2026.



The trial will enroll approximately 76 patients in a multicenter, open-label design.



Phase 1 will use a dose-escalation approach to evaluate safety, tolerability, and dose-limiting toxicities, while determining the recommended dose for further study.



It will also examine pharmacokinetics, pharmacodynamics, and early signs of antitumor activity.



Phase 2 will expand into a dose-optimization stage, focusing on objective response rate as the primary endpoint, alongside secondary measures such as progression-free and overall survival.



<h2>Biomarker Strategy And Translational Focus</h2>



The study incorporates an integrated biomarker program to assess target engagement and pharmacodynamic activity.



Analyses will examine epigenetic changes, including DNA methylation patterns, gene re-expression, and histone modifications.



The company will also explore markers tied to cellular aging and genomic stability, such as telomere dynamics.



These efforts aim to identify potential predictors of response and better understand how epigenetic modulation correlates with clinical outcomes.



TELO Stock Price Activity: Telomir Pharmaceuticals shares were down 3.45% at $1.40 during premarket trading on Thursday, according to Benzinga Pro data.



Photo: Shutterstock

TELO

Telomir Pharmaceuticals has received FDA clearance for its Investigational New Drug application for Telomir-Zn, allowing it to begin a Phase 1/2 clinical trial for advanced or metastatic triple-negative breast cancer (TNBC). The trial, set to start in the first half of 2026, will evaluate safety, tolerability, and efficacy in approximately 76 patients. The study will also incorporate biomarker analyses to assess treatment response and epigenetic changes. Telomir's stock fell 3.45% to $1.40 in premarket trading following the announcement.

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EXCLUSIVE: Telomir Pharmaceuticals Secures FDA Nod For Its Breast Cancer Therapy To Advance Into Human Study