Telomir Pharmaceuticals Secures FDA IND Clearance for Telomir-Zn, Plans Phase 1/2 TNBC Trial
TELO•Telomir Pharmaceuticals obtained FDA clearance for its IND application of Telomir-Zn in advanced or metastatic triple-negative breast cancer. The clearance enables a first-in-human multicenter Phase 1/2 trial in H1 2026 with 76 patients to assess safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity.
1. IND Clearance Enables Clinical Evaluation
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.
2. Phase 1/2 Trial Design and Objectives
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.
3. Mechanism of Telomir-Zn and Preclinical Data
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.
4. Unmet Need in Triple-Negative Breast Cancer
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.
