Oncternal Therapeutics, Inc. (Nasdaq: ONCT) is a clinical-stage biopharmaceutical company dedicated to developing novel oncology treatments. They recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ONCT-534. This designation is for accelerating the development of ONCT-534 as a potential treatment for patients with relapsed or refractory metastatic castration-resistant prostate cancer (mCRPC) who have not responded to approved androgen receptor pathway inhibitors (ARPIs).

Oncternal, expressed the importance of this Fast Track designation in addressing the unmet medical need for patients with mCRPC who relapse after ARPI treatment, such as enzalutamide or abiraterone. ONCT-534's unique mechanism of action has the potential to target androgen receptor (AR) resistance mechanisms that limit the effectiveness of current ARPIs. Oncternal looks forward to collaborating with the FDA, researchers, and industry partners to expedite the development of ONCT-534 for the benefit of patients.

ONCT-534 works by targeting both the N-terminal domain and the ligand-binding domain (LBD) of the androgen receptor (AR), inhibiting cell growth and promoting AR degradation. Preclinical studies have demonstrated its efficacy in prostate cancer models, including those with unmutated AR, as well as cases with various mutations, such as AR amplification, mutations in the AR LBD, and splice variants lacking the AR LBD.

Study ONCT-534-101 is a Phase 1/2 clinical trial, an open-label, single-arm, multi-center study aimed at evaluating the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or proven refractory to approved ARPIs, including enzalutamide, abiraterone, apalutamide, and daralutamide. Following the initial safety and tolerability assessment and preliminary anti-tumor effects in Phase 1, Phase 2 will proceed to further investigate the safety and preliminary anti-tumor activity of ONCT-534 to determine the optimal dosage.

 

Source: globenewswire.com

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