Telomir Pharmaceuticals Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer
Rhea-AI Summary
Telomir Pharmaceuticals (NASDAQ:TELO) submitted an IND to the FDA on March 31, 2026 for Telomir-1 (Telomir-Zn), a first-in-class metal-modulating epigenetic small molecule for advanced and metastatic triple-negative breast cancer (TNBC). The IND includes IND-enabling pharmacology, GLP toxicology, and manufacturing data, and the company plans a Phase 1/2 oral monotherapy trial pending clearance.
Preclinical results showed tumor growth and metastasis reduction, enhanced activity with chemotherapy, favorable GLP safety with no dose-limiting toxicities, and planned biomarker strategies to guide development.
Positive
- IND submission to FDA for Telomir-1 (Telomir-Zn)
- GLP safety studies reported no treatment-related adverse or dose-limiting toxicities
- Preclinical reduction in tumor growth and metastatic dissemination
- Enhanced preclinical activity observed in combination with chemotherapy
Negative
- Clinical data are pending; program remains at IND/preclinical stage
- Planned Phase 1/2 start is contingent on FDA IND clearance
News Market Reaction – TELO
In the Mar 31 session, TELO gained 14.04%, reflecting a significant positive market reaction. Argus tracked a peak move of +8.6% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 17 | TNBC mortality data | Positive | +5.5% | In vitro data showed iron-dependent tumor cell mortality in TNBC models. |
| Feb 05 | Mechanism of action data | Positive | -3.5% | Preclinical cellular data on metal modulation and epigenetic stability for Telomir-Zn. |
| Jan 05 | TNBC animal efficacy | Positive | +11.2% | TNBC xenograft models showed reduced tumor growth and metastasis with Telomir-1. |
| Dec 18 | GLP safety results | Positive | +1.5% | GLP safety studies in rats and dogs showed no treatment-related toxicities. |
| Nov 25 | Prostate cancer data | Positive | +3.1% | Telomir-1 reduced PSA and tumor volume in prostate cancer preclinical models. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Preclinical and program-advancement news has generally seen positive price reactions, with only one negative move despite mostly constructive data updates.
Over the last several months, Telomir has steadily advanced Telomir‑1 through preclinical efficacy and safety milestones toward clinical development. On Nov 25, 2025 and Jan 5, 2026, prostate and TNBC efficacy data produced gains of 3.15% and 11.19%. Favorable GLP safety reported on Dec 18, 2025 was followed by a 1.48% rise. February TNBC mechanistic and mortality data had mixed reactions (+5.5%, -3.45%). Today’s IND submission fits this progression from preclinical validation toward first-in-human trials.
Key Terms
investigational new drug (ind) regulatory
triple-negative breast cancer (tnbc) medical
epigenetic medical
histone demethylases medical
pharmacokinetics medical
3+3 dose-escalation design clinical
simon two-stage design clinical
objective response rate (orr) clinical
AI-generated analysis. How Rhea-AI works. Not financial advice.
First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a favorable GLP safety profile.
MIAMI, FL / ACCESS Newswire / March 31, 2026 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer and age-related disease, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its lead 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 IND clearance, 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.
Mechanism and Scientific Rationale
Telomir-Zn is a first-in-class metal-modulating epigenetic agent designed to restore transcriptional control in tumor cells by targeting intracellular iron-zinc homeostasis, an upstream regulatory node governing several histone demethylases (KDMs) activity, mitochondrial function, and oxidative stress response.
Preclinical studies indicate that Telomir-1 reduces intracellular redox-active iron while increasing zinc availability. This shift suppresses iron-dependent KDMs activities, driving accumulation of repressive histone methylation marks, downregulating oncogenic transcriptional programs, and disrupting cancer cell metabolism. The approach does not rely on nonspecific cytotoxic mechanisms, potentially offering a more targeted profile.
Preclinical Efficacy and Safety
Across multiple preclinical TNBC models, Telomir-Zn demonstrated:
Reduction in tumor growth in aggressive TNBC models
Reduction in metastatic dissemination in a chemotherapy-resistant setting
Iron-dependent tumor cell mortality across human TNBC cell lines
Enhanced activity in combination with chemotherapy in select models
Telomir-Zn has completed IND-enabling GLP safety studies demonstrating:
No treatment-related adverse or dose-limiting toxicities
Favorable cardiovascular, respiratory, and phototoxicity profiles
Consistent systemic exposure and predictable pharmacokinetics
The program is supported by multi-level preclinical studies spanning cellular, in vivo, and safety studies, providing a supportive translational framework for clinical evaluation.
Phase 1/2 Clinical Development Plan
Following IND clearance, the Company plans to initiate a Phase 1/2 clinical study evaluating Telomir-Zn as an oral monotherapy in patients with advanced or metastatic Triple-Negative Breast Cancer.
The Phase 1 portion will utilize a standard 3+3 dose-escalation design to evaluate safety, tolerability, dose-limiting toxicities, and determination of the recommended Phase 2 dose.
The Phase 2 portion will evaluate preliminary antitumor activity using a Simon two-stage design, with objective response rate (ORR) as the primary endpoint, along with duration of response (DoR), progression-free survival (PFS), and continued safety.
The study is designed to identify a clinically meaningful signal of activity.
The Company is also evaluating biomarker strategies aligned with Telomir-Zn's mechanism of action to support patient selection and clinical response assessment.
The Company is currently in discussions with multiple leading U.S.-based cancer centers regarding participation in the planned clinical program.
Clinical Context and Unmet Need
According to Breastcancer.org, breast cancer remains one of the leading causes of cancer-related death globally, with hundreds of thousands of deaths reported each year.
Triple-Negative Breast Cancer accounts for approximately 10
In advanced disease, median overall survival remains approximately 11-13 months, with five-year survival rates of approximately 12
Therapies that can meaningfully improve response rates or durability of response in TNBC have the potential to significantly impact both patient outcomes and the treatment landscape.
The global market for TNBC therapeutics is estimated to be in the multi-billion-dollar range, based on published market research reports, reflecting the significant unmet need for more effective and durable treatment options.
Management Commentary
"This IND submission marks a critical transition from preclinical proof-of-concept to clinical development for Telomir-Zn," said Erez Aminov, Chief Executive Officer of Telomir Pharmaceuticals.
"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 program into the clinic."
Dr. Itzchak Angel, Chief Scientific Advisor at Telomir Pharmaceuticals, added:
"Epigenetic dysregulation, including aberrant histone modification mediated by iron-dependent KDMs, is a central driver of oncogenic transcriptional programs in aggressive cancers such as TNBC. Our data support a mechanistic framework in which modulating intracellular metal homeostasis resets this dysregulation, enabling transcriptional repression of tumor-supporting gene networks without cytotoxic stress. We are excited to evaluate this biology in patients."
Next Steps
Subject to IND clearance, Telomir plans to initiate its Phase 1/2 clinical trial in advanced TNBC and continue advancing biomarker-driven development strategies.
In parallel, the Company is continuing to expand its preclinical program, including evaluation of Telomir-Zn in additional TNBC animal models and further characterization of its mechanism of action.
The Company has submitted scientific manuscripts to peer-reviewed journals and plans to present data at scientific conferences, including the AACR Annual Meeting 2026.
About Telomir Pharmaceuticals
Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) is a preclinical-stage biotechnology company developing small-molecule therapeutics designed to target fundamental epigenetic and metabolic mechanisms implicated in cancer, aging, and degenerative disease. The Company's lead program, Telomir-1 (Telomir-Zn), has demonstrated activity in preclinical studies involving modulation of intracellular metal homeostasis, redox balance, epigenetically regulated gene expression, mitochondrial function, and genomic stability.
Cautionary Note Regarding Forward-Looking Statements
This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1.
Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which are on file with the SEC and available at www.sec.gov. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent 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