USFDAApr 30, 2026, 08:23 AM
TELO: FDA Clears IND for Telomir-Zn in Triple-Negative Breast Cancer
AI Summary
Telomir Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Telomir-Zn. This lead product candidate is intended for the treatment of patients with advanced or metastatic triple-negative breast cancer. The company plans to initiate a first-in-human Phase 1/2 clinical trial in the first half of 2026, which is expected to enroll approximately 76 patients. The study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy, with objective response rate as the primary endpoint for the Phase 2 portion.
Key Highlights
- FDA cleared Investigational New Drug (IND) application for Telomir-Zn.
- Telomir-Zn is the lead product candidate for triple-negative breast cancer.
- Company plans to initiate first-in-human Phase 1/2 trial in 1H 2026.
- The Phase 1/2 study is expected to enroll approximately 76 patients.
- Phase 1 will evaluate safety, tolerability, and pharmacokinetics.
- Phase 2 primary endpoint is objective response rate (ORR) for preliminary efficacy.
- Study includes integrated biomarker analyses for epigenetic modulation and telomere biology.
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