regulatory
confidence high
sentiment positive
materiality 0.80
FDA clears IND for Telomir-Zn in advanced triple-negative breast cancer; Phase 1/2 trial planned for 1H 2026
Telomir Pharmaceuticals, Inc.
- FDA cleared IND for lead candidate Telomir-Zn in advanced/metastatic triple-negative breast cancer.
- Phase 1/2 trial to enroll ~76 patients; Phase 1 dose-escalation, Phase 2 primary endpoint ORR.
- Planned initiation in first half of 2026 at a leading US academic medical center.
- Preclinical data included pharmacology, toxicology, PK, and biomarker analyses.
- Translational biomarker program to assess epigenetic modulation and telomere dynamics.
item 8.01