Enables ATX-559 Phase 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and solid tumors with microsatellite instability (MSI-H) and/or deficient mismatch repair (dMMR); first patient dosed anticipated in Q4 2024 Second program targeting KIF18A on track to enter clinical trials in early 2025, underscoring rapid advancement of novel therapies Clinical Advisory Board (CAB) of global oncology drug development experts formed to support the advancement of Accent's clinical pipeline LEXINGTON, Mass. , Oct. 24, 2024 /PRNewswire/ -- Accent Therapeutics, a biopharmaceutical company pioneering novel small molecule targeted cancer therapeutics, today announced that the U.
S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATX-559, a first-in-class DHX9 inhibitor. In addition, Accent has established a Clinical Advisory Board (CAB) to help guide the Company's progress in the clinic.
The ATX-559 Phase 1/2 trial (NCT06625515) is expected to begin dosing patients with a focus on BRCA1- or BRCA2-deficient breast cancer and patients with MSI-H and/or dMMR solid tumors (including certain patients with colorectal, endometrial, gastric, and other cancers) in the fourth quarter of 2024. The clinical study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ATX-559. For more information on the trial, visit the study page on ClinicalTrials.
gov . "The FDA's IND clearance .
