NEW YORK – Accutar Biotechnology said on Saturday that China's National Medical Products Administration (NMPA) cleared its investigational new drug application to study AC0682 in a Phase I trial involving estrogen receptor (ER)-positive breast cancer patients.
The company will begin the study of AC0682, an estrogen receptor-alpha degrader, in China in the second half of this year. The trial will explore the drug's safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in Chinese patients with ER-positive breast cancer.
In December, Accutar initiated another Phase I study in the US of AC0682 as a single-agent in ER-positive HER2-negative advanced breast cancer patients. The company aims to enroll 30 patients in this study and evaluate the drug's safety, tolerability, and anti-tumor activity, including patients' objective response rate, clinical benefit rate, duration of response, disease control rate, and progression-free survival on AC0682.
In preclinical studies, AC0682 showed promising anti-tumor activity in ER-positive mouse models. Estrogen receptor-alpha is expressed in nearly 80 percent of breast cancers, and plays a role in cancer proliferation, according to Accutar.
Shanghai-based Accutar has two other clinical-stage oncology drugs in its pipeline: AC0176, an androgen receptor degrader being studied in metastatic castration-resistant prostate cancer, and AC0676, being studied in blood cancers and autoimmune diseases.