BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers. AC0682 is an orally bioavailable, chimeric degrader molecule designed to target and degrade ERα protein with high potency and selectivity. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation, and nearly 80% of breast cancers express ERα. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0682 in the last quarter of this year.
“The IND clearance for AC0682 is a key milestone for Accutar and AI-enabled drug discovery. This is an important validation that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders. To bring one of the world’s first wave of AI-enabled molecules into clinics with our own platform is a great achievement,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “The IND clearance for AC0682 is also critical towards offering a potential new breast cancer treatment based on a differentiated mechanism of action from fulvestrant, which is the current standard of care for this patient population. We look forward to the clinical benefit that AC0682 treatment can potentially provide to the ER-positive breast cancer patients.”
“Treatment options are limited for patients with metastatic ER+ breast cancer after hormonal and CDK4/6 inhibitor treatment,” said Dr. Erika Hamilton, Director, Breast Cancer and Gynecologic Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, and the lead Principal Investigator for the study. “AC0682 potentially addresses an unmet clinical need for patients post endocrine therapy and CDK4/6 inhibitors who need additional treatment options. We look forward to exploring this novel drug to advance care for people facing ER+ metastatic breast cancer.”
The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in ER-positive breast cancer patients. Additional information on this clinical trial can be found on www.clinicaltrials.gov.
AC0682 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α for the potential treatment of ER-positive breast cancers. In preclinical studies, AC0682 has demonstrated potent and selective ERα protein degradation with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.
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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To learn more about Accutar, please visit us at www.accutarbio.com.