Telomir Pharmaceuticals has received FDA clearance of its IND for Telomir-Zn targeting advanced or metastatic triple-negative breast cancer, backed by a comprehensive submission of pharmacology, toxicology, manufacturing and pharmacokinetic data that paves the way for clinical evaluation.

The TELO-001 study is a first-in-human, multicenter, open-label Phase 1/2 trial enrolling approximately 76 patients using a modified 3+3 dose-escalation design to determine the maximum tolerated dose and recommended Phase 2 dose, followed by a Simon’s two-stage expansion to assess objective response rate, with secondary endpoints including duration of response, progression-free survival, overall survival and safety.

Telomir-Zn is designed to modulate intracellular iron and zinc homeostasis to influence metal-dependent epigenetic enzymes, with preclinical studies demonstrating systemic exposure and antitumor activity in TNBC models alongside integrated biomarker analyses of DNA methylation, gene re-expression, telomere dynamics and histone modifications to evaluate target engagement and potential predictors of clinical response.

Triple-negative breast cancer comprises 10–15% of breast cancer cases, is characterized by aggressive biology and limited treatment options in the advanced or metastatic setting, and represents a multi-billion-dollar market opportunity for novel epigenetic-metabolic therapies like Telomir-Zn.