Telomir Pharmaceuticals (NASDAQ: TELO) announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead candidate, Telomir-1 (Telomir-Zn), targeting advanced and metastatic triple-negative breast cancer (TNBC). The company indicated that preclinical data supporting the application demonstrated tumor growth reduction and a favorable tolerability profile. This IND submission marks a critical step toward clinical development for a therapy designed to address a significant unmet need in one of the most aggressive forms of breast cancer.
Triple-negative breast cancer, which lacks estrogen, progesterone, and HER2 receptors, accounts for approximately 15-20% of all breast cancers and is associated with a poorer prognosis due to limited treatment options. Current therapies often involve chemotherapy, which can be highly toxic. Telomir-1, an oral small molecule, aims to modulate fundamental epigenetic and metabolic mechanisms, including intracellular metal homeostasis, redox balance, and genomic stability. According to the company, preclinical studies have shown that Telomir-1 can reduce tumor growth and is well tolerated.
Pending IND clearance, Telomir Pharmaceuticals plans to initiate a Phase 1/2 clinical trial evaluating Telomir-1 in patients with advanced or metastatic TNBC. The trial will focus on safety, dose optimization, and early signs of antitumor activity. The company is advancing a novel epigenetic approach that could potentially offer a new therapeutic option for patients who currently have few alternatives. The full press release can be accessed at https://ibn.fm/CgUik.
Telomir Pharmaceuticals, Inc. (NASDAQ: TELO) is a preclinical-stage biotechnology company developing small-molecule therapeutics targeting 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. For the latest news and updates relating to TELO, visit the company’s newsroom at https://ibn.fm/TELO.
