Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical Center.
MIAMI, FL / ACCESS Newswire / April 30, 2026 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer and age-related disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its lead candidate, Telomir-Zn, for the treatment of patients with advanced or metastatic triple-negative breast cancer (TNBC).
This IND clearance enables the Company to advance Telomir-Zn into clinical evaluation, representing an important step toward addressing a significant unmet need in patients with advanced or metastatic triple-negative breast cancer, where treatment options remain limited, and outcomes are poor.
IND Clearance and Development Package
The FDA's clearance reflects review of a comprehensive IND submission supporting advancement of Telomir-Zn into clinical evaluation. The submission included pharmacology, toxicology, manufacturing data, and the Company's first-in-human Phase 1/2 clinical study protocol (TELO-001).
The IND package was supported by completed IND-enabling studies, including pharmacology and toxicology evaluations, pharmacokinetic data demonstrating systemic exposure, and preclinical data indicating activity in models of triple-negative breast cancer.
Planned Phase 1/2 Clinical Trial
The planned clinical study (TELO-001) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of Telomir-Zn as an oral monotherapy in patients with advanced or metastatic TNBC.
Study Overview
First-in-human, multicenter, open-label Phase 1/2 trial
Adult patients with advanced or metastatic TNBC who have received prior systemic therapy
Planned enrollment of approximately 76 patients
Phase 1: Dose Escalation
Modified 3+3 dose-escalation design
Evaluation of safety, tolerability, and dose-limiting toxicities
Determination of maximum tolerated dose and recommended Phase 2 dose
Assessment of pharmacokinetics, pharmacodynamics, and preliminary antitumor activity
Integrated biomarker analyses to evaluate epigenetic modulation, gene re-expression, and telomere-related biology associated with cellular aging and genomic stability
Phase 2: Dose Expansion
Simon's two-stage design to assess preliminary efficacy
Primary endpoint is objective response rate (ORR)
Secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety
The study will incorporate pharmacokinetic, pharmacodynamic, and biomarker analyses to evaluate target engagement and explore potential correlations between epigenetic modulation and clinical outcomes
Translational and Biomarker Strategy
The study includes an integrated biomarker program designed to evaluate pharmacodynamic activity, target engagement, and potential predictors of response.
Biomarker analyses will assess changes in epigenetic regulation, including global DNA methylation, gene re-expression of epigenetically silenced tumor suppressor pathways, and histone modification patterns associated with tumor biology.
In addition, exploratory analyses will evaluate biomarkers related to cellular aging and genomic stability, including telomere dynamics and associated epigenetic signatures, with the objective of understanding the broader biological activity of Telomir-Zn across oncology and age-related pathways.
The study will also assess correlations between biomarker modulation and clinical outcomes, including preliminary antitumor activity, objective response, and progression-free survival, and may inform identification of potential predictive biomarkers of response.
Clinical Development Strategy
The Company plans to initiate the Phase 1/2 clinical trial in the first half of 2026, anchored by a leading U.S. academic medical center, with potential expansion to additional oncology sites.
Mechanism of Action
Telomir-Zn is an investigational small-molecule designed to represent a novel therapeutic approach and a potentially first-in-class strategy focused on modulation of intracellular metal homeostasis and downstream epigenetic regulation.
Unlike conventional cytotoxic chemotherapy, immune checkpoint inhibition, antibody-drug conjugates, or classic epigenetic drugs, Telomir-Zn is being developed to target metal-dependent epigenetic vulnerabilities that may contribute to tumor progression, treatment resistance, genomic instability, and cancer-associated aging biology.
Preclinical studies indicate that Telomir-Zn alters intracellular iron and zinc balance, modulates iron-dependent chromatin-regulating enzymes, and influences gene expression and cellular pathways associated with tumor biology, genomic stability, and cellular aging.
Clinical Context
Breast cancer is the most commonly diagnosed cancer worldwide, with approximately 2.3 million new cases diagnosed annually, according to the World Health Organization.
Triple-negative breast cancer represents approximately 10 to 15 percent of cases and is associated with aggressive disease biology and limited treatment options, particularly in the advanced or metastatic setting.
Despite available therapies, outcomes remain poor, and TNBC continues to represent a multi-billion-dollar global market with significant unmet medical need.
Management Commentary
"The clearance of our IND, including the Phase 1/2 clinical protocol, marks an important step as we advance Telomir-Zn into clinical evaluation," said Erez Aminov, CEO of Telomir.
"Triple-negative breast cancer remains one of the most difficult cancers to treat in the advanced or metastatic setting, with limited options and consistently poor outcomes. There is a clear need for new therapeutic approaches, and we look forward to evaluating Telomir-Zn in this patient population."
Dr. Itzchak Angel, Chief Scientific Advisor, added:
"Telomir-Zn is designed to target fundamental aspects of tumor biology through modulation of intracellular metal balance and epigenetic regulation. This metal-epigenetic approach represents a differentiated therapeutic strategy that may have relevance not only in triple-negative breast cancer but also across broader cancer and age-related disease biology."
About Telomir Pharmaceuticals
Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) is a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic pathways implicated in cancer, aging, and degenerative disease. The Company's lead program, Telomir-1 (Telomir-Zn), is designed to modulate intracellular metal homeostasis and epigenetic regulation.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's plans to initiate clinical trials, clinical development strategy, and the potential therapeutic effects of Telomir-Zn. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially.
Such risks include, but are not limited to, regulatory developments, the timing and outcome of clinical trials, and the Company's ability to execute its development plans. Additional risks are described in the Company's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information
Krystina Quintana
Email: info@telomirpharma.com
Phone: (786) 396-6723
SOURCE: Telomir Pharmaceuticals, Inc
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/telomir-pharmaceuticals-announces-fda-clearance-of-ind-for-telomir-zn-1162409
