A Novel Epigenetic Approach to Oncology
Telomir’s current clinical pipeline is focused on Telomir-Zn in Triple-Negative Breast Cancer (TNBC).
IND Filed
March 31, 2026
FDA Clearance
April 24, 2026
anticipated Q1 2027*
First Patient In
anticipated 1H 2027*
Asset
Telomir-Zn
Indication
Triple-Negative Breast Cancer (TNBC)
Preclinical
IND Cleared
Phase 1/2
Anticipated Q1 2027*
Phase 3
*Anticipated timing is subject to change based on clinical, regulatory, operational, and other factors.
Phase 1
Modified 3+3 dose escalation evaluating safety, tolerability, PK/PD, and preliminary antitumor activity, while establishing the recommended Phase 2 dose (RP2D).
Phase 2
Simon two-stage design evaluating preliminary efficacy at the RP2D, with Objective Response Rate (ORR) as the primary endpoint.
Indication
Triple-Negative Breast Cancer (TNBC)
~50,000 new U.S. diagnoses annually
Median overall survival of 8–13 months in metastatic disease
Initial Positioning
Second-line and later treatment of advanced or metastatic TNBC, where significant unmet need remains following existing therapies.
Clinical Sites
Site activations are underway at leading U.S. academic cancer centers.
Why TNBC remains difficult to treat
High risk of recurrence and disease progression
Resistance remains a significant challenge, and durable responses are limited