The IND submission includes comprehensive data from completed IND-enabling pharmacology, toxicology, and manufacturing studies. If approved, the company plans to initiate a Phase 1/2 clinical trial to evaluate Telomir-1 as an oral monotherapy in patients with advanced or metastatic TNBC. The Phase 1 portion will utilize a standard 3+3 dose-escalation design to assess safety, tolerability, and dose-limiting toxicities, while the Phase 2 portion will focus on preliminary antitumor activity, with objective response rate as the primary endpoint.
Telomir-1 is a small-molecule therapeutic that aims to reduce redox-active iron levels and increase zinc availability, which is crucial for inhibiting iron-dependent epigenetic enzyme activity. Preclinical studies have indicated that Telomir-Zn can significantly reduce tumor growth and metastatic spread in TNBC models, demonstrating its potential as a viable treatment option. The company has also reported no treatment-related adverse effects or dose-limiting toxicities in prior safety studies.
Telomir Pharmaceuticals is committed to advancing its research and development efforts, continuing to evaluate Telomir-Zn in additional preclinical TNBC models, and developing biomarker strategies to support clinical development. The company has plans to present its findings at scientific conferences, including the AACR Annual Meeting 2026, further solidifying its position in the oncology space.
