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news.Telomir Pharmaceuticals has submitted an investigational new drug application to the US Food and Drug Administration for Telomir-1 (Telomir-Zn), its lead candidate targeting advanced and metastatic triple-negative breast cancer (TNBC).
The safety studies reported no toxicities, favourable safety profiles, consistent systemic exposure, and predictable pharmacokinetics. Credit: Sai Thaw Kyar / Shutterstock.com.
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The IND includes results from completed toxicology, pharmacology, and manufacturing studies necessary for regulatory assessment.
Pending IND clearance, Telomir Pharmaceuticals aims to start a Phase I/II clinical trial of Telomir-1 as an oral single agent for patients with advanced or metastatic TNBC.
Telomir-Zn is described as a first-in-class metal-modulating epigenetic agent designed to restore transcriptional control in tumour cells.
According to to a company release, Telomir said that IND-enabling good laboratory practice (GLP) safety studies reported no treatment-related or dose-limiting toxicities and favourable cardiovascular, respiratory, and phototoxicity profiles. Systemic exposure was consistent, and pharmacokinetics were predictable.
The Phase I segment of the trial will use a standard three-plus-three dose-escalation design to evaluate the safety, tolerability, dose-limiting toxicities, and recommended Phase II dose.
Phase II will use a Simon two-stage design to assess preliminary antitumour activity through objective response rate as the primary endpoint, along with duration of response, progression-free survival, and continued safety evaluation.
Telomir Pharmaceuticals has submitted manuscripts to peer-reviewed journals and plans to present its findings at scientific conferences, including the American Association for Cancer Research (AACR) annual meeting in 2026.
Telomir Pharmaceuticals CEO Erez Aminov said: “This IND submission marks a critical transition from preclinical proof-of-concept to clinical development for Telomir-Zn.
“TNBC patients with advanced disease have few durable treatment options, and we believe that targeting the biological mechanisms driving treatment resistance, specifically iron-dependent epigenetic dysregulation, represents a differentiated and scientifically grounded approach. We look forward to advancing this programme into the clinic.”
