Regor announces the first patient dosed in the U.S. in the Phase I clinical trial for RGT-419B, a CDK2/4/6 inhibitor for advanced/metastatic breast cancer
Regor Therapeutics Group, a clinical-stage biotech company focusing on immunology, oncology, and metabolic disorders, announced today that the first patient has been dosed in the Phase I clinical trial of the Company’s next generation targeted inhibitor RGT-419B for the treatment of breast cancer.
RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to combat the resistance to currently approved CDK4/6 inhibitors that are given in combination with endocrine-based therapy for treatment of pre/perimenopausal or postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. The Phase I clinical trial is in the form of non-randomized, open-label first-in-human clinical study, exploring ascending dose of RGT-419B in hormone receptor-positive HER-2 receptor-negative patients with advanced or metastatic breast cancer under monotherapy or combination endocrine therapy conditions. The study was initiated in March 2022 and the first patient dosing was completed in the U.S.
Preclinical studies indicates that RGT-419B has demonstrated full suppression of cancer cell proliferation in a CDK4/6 inhibitor-resistant ER+ breast cancer cell model. Also, data from preclinical studies suggest that the inhibitory effect of RGT-419B on cancer cells is further enhanced when combined with selective estrogen receptor degraders (SERD) or PI3K inhibitors.
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.