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Telomir Pharmaceuticals Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer

TELO
  • Telomir Pharmaceuticals (NASDAQ: TELO) submitted an Investigational New Drug (IND) application to the U.S. FDA for its lead candidate Telomir-1 (Telomir-Zn) to treat advanced & metastatic Triple-Negative Breast Cancer (TNBC).
  • Telomir-1 is a first-in-class metal-modulating epigenetic agent targeting intracellular iron-zinc homeostasis to regulate histone demethylase activity, mitochondrial function, & oxidative stress.
  • Preclinical studies show Telomir-Zn reduces redox-active iron, increases zinc availability, suppresses iron-dependent KDMs, & disrupts cancer cell metabolism without relying on nonspecific cytotoxic mechanisms.
  • The drug demonstrated efficacy in multiple preclinical TNBC models by reducing tumor growth, inhibiting metastatic dissemination in chemotherapy-resistant settings, & inducing iron-dependent tumor cell mortality.
  • GLP safety studies revealed no treatment-related adverse or dose-limiting toxicities, with favorable cardiovascular, respiratory, & phototoxicity profiles.
  • Upon IND clearance, the Company plans a Phase 1/2 clinical trial evaluating Telomir-Zn as an oral monotherapy in patients with advanced or metastatic TNBC.
  • The Phase 1 portion will use a 3+3 dose-escalation design to assess safety, tolerability, & determine the recommended Phase 2 dose.
  • The Phase 2 portion will utilize a Simon two-stage design with objective response rate (ORR) as the primary endpoint, alongside duration of response, progression-free survival, & continued safety assessments.
  • The Company is evaluating biomarker strategies aligned with the drug's mechanism of action & is in discussions with U.S. cancer centers for trial participation.
  • TNBC represents 10-15% of breast cancer cases with limited treatment options, median overall survival of 11-13 months, & response rates to current therapies ranging from 20% to 40%.
  • Telomir Pharmaceuticals is a preclinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic & metabolic drivers of cancer & age-related disease.
  • The Company intends to present data at the AACR Annual Meeting 2026 & has submitted scientific manuscripts to peer-reviewed journals.