Telomir Pharmaceuticals (NASDAQ: TELO) announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Telomir-1 (Telomir-Zn), targeting advanced and metastatic triple-negative breast cancer (TNBC). The IND submission is supported by preclinical efficacy and safety data demonstrating tumor growth reduction and favorable tolerability, according to a press release from the company.
Pending IND clearance, Telomir plans to initiate a Phase 1/2 clinical trial evaluating the oral therapy. The trial will focus on safety, dose optimization, and early signs of antitumor activity. Telomir-1 represents a novel epigenetic approach aimed at addressing significant unmet need in aggressive breast cancer. Triple-negative breast cancer is a particularly challenging subtype that lacks targeted therapies and has a poor prognosis.
Telomir Pharmaceuticals 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, has demonstrated activity in preclinical studies involving modulation of intracellular metal homeostasis, redox balance, epigenetically regulated gene expression, mitochondrial function, and genomic stability.
The IND submission marks a critical step toward clinical development. For more details, the full press release is available at https://ibn.fm/CgUik. The latest news and updates relating to TELO can be found in the company’s newsroom at https://ibn.fm/TELO.
This development is significant because TNBC represents an area of high unmet medical need, and Telomir-1’s novel mechanism of action could provide a new treatment option. If successful, the therapy could improve outcomes for patients with this aggressive form of cancer.
