Telomir Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 – Other Events
Telomir Pharmaceuticals Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer
First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a favorable GLP safety profile.
On March 31, 2026, Telomir Pharmaceuticals, Inc. (the “Company”) announced the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration for its lead investigational candidate, Telomir-1 (Telomir-Zn), for the treatment of advanced and metastatic Triple-Negative Breast Cancer (TNBC).
The IND submission includes data from completed IND-enabling pharmacology, toxicology, and manufacturing studies. Subject to clearance of the IND by the FDA, the Company plans to initiate a Phase 1/2 clinical trial evaluating Telomir-1 as an oral monotherapy in patients with advanced or metastatic TNBC.
The planned Phase 1 portion of the study is expected to utilize a standard 3+3 dose-escalation design to evaluate safety, tolerability, dose-limiting toxicities, and determination of a recommended Phase 2 dose. The Phase 2 portion is expected to evaluate preliminary antitumor activity using a Simon two-stage design, with objective response rate as the primary endpoint.
Telomir-1 is a small-molecule therapeutic designed to modulate intracellular metal homeostasis, including the reduction of redox-active iron and the increase of zinc availability. It is developed as a zinc-containing substance, called Telomir-Zn. Preclinical studies indicate that this mechanism is associated with inhibition of iron-dependent epigenetic enzyme activity, including histone demethylases (KDMs), which result in accumulation of histone methylation marks associated with transcriptional repression.
The Company reported that, in preclinical studies, Telomir-Zn demonstrated a reduction in tumor growth and metastatic dissemination in TNBC models, as well as iron-dependent tumor cell mortality across several human TNBC cell lines. The Company has also previously reported results from IND-enabling Good Laboratory Practice (GLP) safety studies in which no treatment-related adverse or dose-limiting toxicities were observed.
The Company stated that it is continuing to evaluate Telomir-Zn in additional preclinical TNBC models and is advancing biomarker strategies to support clinical development. The Company also indicated that it has submitted scientific manuscripts to peer-reviewed journals and plans to present data at scientific conferences, including the AACR Annual Meeting 2026.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TELOMIR PHARMACEUTICALS, INC. | ||
| Dated: March 31, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |