BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AC0176 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) with disease progression on or after treatment with androgen receptor signaling inhibitors. AC0176 is an orally bioavailable, chimeric degrader molecule targeting the androgen receptor (AR). AC0176 is currently being evaluated in a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with mCRPC.

“mCRPC is a devastating cancer for men marked by high recurrence rate and poor survival. Receiving Fast Track designation from the FDA highlights the high unmet medical need for mCRPC and acknowledges the potential of AC0176 as a novel treatment for this patient population,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutations which confer drug resistance to current AR signaling inhibitors. We look forward to continued interaction with FDA as we quickly advance the development of this potentially promising treatment option for patients in need.”

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate cancer (PC) is the second most commonly diagnosed cancer among men worldwide, and the first among men in the United States. mCRPC is a lethal diagnosis, and more effective therapeutic approaches are urgently needed for patients, particularly those who progressed on AR signaling inhibitors. AR-reactivating mechanisms conferring resistance to AR signaling inhibitors include, AR amplification and overexpression, AR point mutations, AR splicing variants, intra-tumoral androgen synthesis, promiscuous AR activation by other factors, etc.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation, favorable pharmacological properties, as well as promising anti-tumor activity in animal models. AC0176 was designed to have broad coverage of AR wildtype and prevalent AR mutations, including but not limited to L702H, T878A, H875Y, W742C. AC0176 is being evaluated in a Phase 1 clinical trial, and information on the study can be found on (NCT05241613).

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines.

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Jiaqi Ren