Regor announces China NMPA approval of the IND for RGT-419B capsule, a CDK2/4/6 inhibitor for advanced/metastatic breast cancer
Regor Therapeutics Group announced that the investigational new drug (IND) application of RGT-419B capsule, a CDK2/4/6 small molecule inhibitor, had been approved by the National Medical Products Administration (NMPA) of China. A Phase I clinical study will be conducted in Chinese patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced/metastatic breast cancer, including patients who are resistant to approved CDK4/6 inhibitors, to evaluate the safety, tolerability and pharmacokinetic profile of RGT-419B capsule.
RGT-419B is the first of a series of innovative oncology drugs being developed by Regor Therapeutics Group. The U.S. Food and Drug Administration (FDA) approved its early clinical development plan for patients with HR+/HER2- advanced/metastatic breast cancer and the dosing of the first patient was accomplished on April 8, 2022.
About RGT-419B
RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B`s tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor.
The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer.
About Breast Cancer
According to the latest cancer data released by the World Health Organization International Agency for Research on Cancer (IARC), breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.26 million new cases in 2020. In China, breast cancer is the most common malignancy among women, with 416,371 new cases and 117,174 deaths in 2020. HR+/HER2- breast cancer is the most common subtype, accounting for over 70% of female patients. Breast cancer poses a tremendous medical burden and has a significant negative impact on patients and their families in China and across the world.
About Regor Therapeutics Group
Regor Therapeutics Group is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary rCARDTM (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating rCARDTM with structural biology, computational biology, computational chemistry and other disciplines, Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules.