Telomir Pharmaceuticals(US:TELO) Accessnewswire·2026-03-31 12:00Core Viewpoint - Telomir Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA for its lead candidate, Telomir-1 (Telomir-Zn), aimed at treating advanced and metastatic Triple-Negative Breast Cancer (TNBC) [3][4]. Company Overview - Telomir Pharmaceuticals, Inc. is a biotechnology company focused on developing small-molecule therapeutics that target epigenetic and metabolic drivers of cancer and age-related diseases [3][16]. IND Submission Details - The IND submission includes data from completed pharmacology, toxicology, and manufacturing studies, with plans to initiate a Phase 1/2 clinical trial for Telomir-1 as an oral monotherapy in TNBC patients [4][7]. - Telomir-Zn is described as a first-in-class metal-modulating epigenetic agent that targets iron-zinc homeostasis, influencing histone demethylases activity and oxidative stress response [4][5]. Preclinical Efficacy and Safety - Preclinical studies have shown that Telomir-1 reduces tumor growth and metastatic dissemination in aggressive TNBC models, demonstrating enhanced activity in combination with chemotherapy [5][6]. - The safety profile of Telomir-Zn is favorable, with no treatment-related adverse effects reported in GLP safety studies [6]. Clinical Development Plan - The Phase 1 portion of the clinical trial will utilize a 3+3 dose-escalation design to assess safety and tolerability, while the Phase 2 portion will focus on preliminary antitumor activity with objective response rate as the primary endpoint [7][8]. - The company is also exploring biomarker strategies to support patient selection and clinical response assessment [8]. Market Context and Unmet Need - TNBC accounts for approximately 10-15% of all breast cancer cases and is known for its aggressive nature and limited treatment options, with median overall survival in advanced cases being around 11-13 months [10][11]. - The global market for TNBC therapeutics is projected to be in the multi-billion-dollar range, highlighting the significant unmet need for effective treatment options [12]. Management Commentary - The CEO of Telomir Pharmaceuticals emphasized the importance of this IND submission as a transition to clinical development, targeting the biological mechanisms driving treatment resistance in TNBC [12][13]. Next Steps - Following IND clearance, the company plans to initiate its Phase 1/2 clinical trial and continue expanding its preclinical program, including further evaluation of Telomir-Zn in additional TNBC models [14].