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

  • Telomir Pharmaceuticals received FDA clearance for its Investigational New Drug application for lead candidate Telomir-Zn to treat advanced or metastatic triple-negative breast cancer.
  • The company plans to initiate the first-in-human Phase 1/2 clinical trial (TELO-001) in the first half of 2026, anchored by a leading U.S. academic medical center.
  • The trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, & preliminary antitumor activity of Telomir-Zn as an oral monotherapy in approximately 76 adult patients.
  • Phase 1 utilizes a modified 3+3 dose-escalation design to determine the maximum tolerated dose & recommended Phase 2 dose while assessing safety & biomarkers.
  • Phase 2 employs a Simon's two-stage design with the primary endpoint of objective response rate & secondary endpoints including duration of response, progression-free survival, overall survival, & safety.
  • Telomir-Zn is a small-molecule therapeutic designed to modulate intracellular metal homeostasis & downstream epigenetic regulation, targeting metal-dependent vulnerabilities in tumor biology.
  • The study includes an integrated biomarker program to assess epigenetic modulation, gene re-expression, telomere dynamics, & correlations with clinical outcomes.
  • Telomir-Zn represents a potentially first-in-class strategy distinct from conventional chemotherapy or classic epigenetic drugs by focusing on intracellular iron & zinc balance.
  • Triple-negative breast cancer accounts for 10 to 15 percent of breast cancer cases & is characterized by aggressive biology & limited treatment options in advanced settings.
  • CEO Erez Aminov & Chief Scientific Advisor Dr. Itzchak Angel emphasized the significance of the IND clearance for addressing unmet medical needs in TNBC.