Oncternal Therapeutics announces Fast Track designation for ONCT-534

Oncternal Therapeutics announced that the U.S. Food and Drug Administration has designated ONCT-534, its novel dual-acting androgen receptor inhibitor, as a Fast Track development program for the investigation of the treatment of patients with relapsed or refractory metastatic castration-resistant prostate cancer resistant to approved androgen receptor pathway inhibitors. ONCT-534 interacts with both the N-terminal domain and the ligand-binding domain of the AR, inhibiting cell growth and inducing AR degradation. Preclinical studies have shown activity in prostate cancer models against both unmutated AR, and against multiple mutations, including AR amplification, mutations in the AR LBD, and splice variants with loss of the AR LBD.