Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer

About this update from Telomir Pharmaceuticals, Inc.

Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical Center. MIAMI, FL / ACCESS Newswire / April 30, 2026 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer and age-related disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its lead candidate, Telomir-Zn, for the treatment of patients with advanced or metastatic triple-negative breast cancer (TNBC). This IND clearance enables the Company to advance Telomir-Zn into clinical evaluation, representing an important step toward addressing a significant unmet need in patients with advanced or metastatic triple-negative breast cancer, where treatment options remain limited, and outcomes are poor. IND Clearance and Development Package The FDA's clearance reflects review of a comprehensive IND submission supporting advancement of Telomir-Zn into clinical evaluation. The submission included pharmacology, toxicology, manufacturing data, and the Company's first-in-human Phase 1/2 clinical study protocol (TELO-001). The IND package was supported by completed IND-enabling studies, including pharmacology and toxicology evaluations, pharmacokinetic data demonstrating systemic exposure, and preclinical data indicating activity in models of triple-negative breast cancer. Planned Phase 1/2 Clinical Trial The planned clinical study (TELO-001) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of Telomir-Zn as an oral monotherapy in patients with advanced or metastatic TNBC. Study Overview Phase 1: Dose Escalation Phase 2: Dose Expansion Translational and Biomarker Strategy The study includes an integrated biomarker program designed to evaluate pharmacodynamic activity, target engagement, and potential predictors of response. Biomarker analyses will assess changes in epigenetic regulation, including global DNA methylation, gene re-expression of epigenetically silenced tumor suppressor pathways, and histone modification patterns associated with tumor biology. In addition, exploratory analyses will evaluate biomarkers rela...

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