Telomir Pharmaceuticals submits IND to FDA for Telomir-1 in metastatic triple-negative breast cancer

Telomir Pharmaceuticals, Inc.

IND submitted March 31, 2026 for oral Telomir-Zn (Telomir-1) in advanced/metastatic TNBC.
Data from IND-enabling pharmacology, toxicology, and manufacturing studies included in submission.
Planned Phase 1/2 trial: 3+3 dose-escalation, then Simon two-stage with ORR as primary endpoint.
Preclinical GLP safety studies showed no treatment-related adverse or dose-limiting toxicities.
Telomir-1 reduces redox-active iron and increases zinc, inhibiting iron-dependent histone demethylases.

item 8.01

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