On December 28, 2021, the new generation of CDK2/4/6 small molecule inhibitor RGT-419B independently developed by Regor Therapeutics Group (Regor) was approved by the U.S. Food and Drug Administration (FDA). It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors.
As a collaborative partner of Regor, Shanghai Medicilon Inc. (Medicilon) provided RGT-419B with a toxicological DRF test that complies with GLP specifications to accelerate the project's R&D process.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
RGT-419B has an optimized kinase activity profile, which is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.
In the cell model experiments, RGT-419B showed single-drug activity, and compared with abemaciclib and palbociclib, it had a greater inhibitory effect on the growth of ER+ tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with selective estrogen receptor degradants or PI3K signaling pathway inhibitors, its inhibitory effect on tumor cells is further enhanced.
In the development of RGT-419B, Medicilon relied on 13 years of GLP good operating experience and 18 years of toxicological research experience to provide necessary and key toxicological test data for RGT-419B. Efficient service and high-quality data helped Regor to increase the successful rate of declaration and reduce the cost of new drug research and development.
Medicilon congratulates Regor on the clinical approval of RGT-419B, and expects this new drug with great potential to benefit more cancer patients as soon as possible. Medicilon also congratulates Regor on its milestone progress and successfully entering the field of tumor treatment. Medicilon will continue to uphold the "innovation-driven, quality first" service concept to help more new drugs develop faster and to help more innovative biopharmaceutical companies to go global!
Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating CARD with structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development, 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.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.
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