TELO 8-K
Telomir Pharmaceuticals, Inc. (TELO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events
Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer
Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical Center
Telomir Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”), has cleared the Company’s Investigational New Drug (“IND”) application for its lead product candidate, Telomir-Zn, for the treatment of patients with advanced or metastatic triple-negative breast cancer.
The Company’s IND submission included preclinical pharmacology and toxicology data, pharmacokinetic data, manufacturing information, and a Phase 1/2 clinical study protocol, as well as preclinical data supporting biological activity in models of triple-negative breast cancer.
The planned Phase 1/2 study is expected to enroll approximately 76 patients and will consist of a dose-escalation Phase 1 portion followed by a dose-expansion Phase 2 portion.
The Phase 1 portion of the study is designed to evaluate safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, and to determine the maximum tolerated dose and recommended Phase 2 dose. The study will include integrated biomarker analyses to evaluate epigenetic modulation, gene re-expression, and telomere-related biology associated with cellular aging and genomic stability.
The Phase 2 portion of the study is designed to evaluate preliminary efficacy, with the objective response rate (ORR) as the primary endpoint. Secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. The study will also incorporate pharmacokinetic, pharmacodynamic, and biomarker analyses to evaluate target engagement and explore potential correlations between biomarker modulation and clinical outcomes.
The study includes a translational biomarker program designed to evaluate pharmacodynamic activity, target engagement, and potential predictors of response. Biomarker analyses will assess epigenetic regulation, including global DNA methylation, gene expression, and histone modification patterns, as well as exploratory biomarkers related to cellular aging and genomic stability, including telomere dynamics.
The Company plans to initiate the Phase 1/2 clinical trial in the first half of 2026, subject to standard clinical and operational considerations.
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: April 30, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |