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health1d ago
Telomir Pharmaceuticals gets FDA IND clearance for Telomir-Zn, Phase 1/2 trial planned for 1H 2026
- FDA clears Telomir-Zn IND, enabling a Phase 1/2 trial for advanced TNBC in 1H 2026.
- The Phase 1/2 study will enroll about 76 patients with dose-escalation and expansion.
- Phase 1 will assess safety, MTD, recommended Phase 2 dose, PK/PD, and biomarker work.
- Phase 2 will evaluate efficacy with ORR as the primary endpoint and other endpoints including DoR, PFS, OS, and safety.
- The announcement references Telomir Pharmaceuticals’ SEC filing and notes the summary may contain inaccuracies.
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