SHANGHAI, Dec. 27 2021 / PRNewswire / – At 23 december, Regor Therapeutics, a clinical-stage biotechnology company, authorization announced from US Food and Drug Administration (FDA) continue Regor’s Phase 1 clinical development plans for RGT-419B.
RGT-419B is a new generation CDK2 / 4/6 small molecule inhibitor with an optimized kinase activity spectrum. It is expected to improve safety and combat resistance to currently approved CDK4 / 6 inhibitors which are given in combination with endocrine therapy for the treatment of pre / perimenopausal or postmenopausal women with hormone receptor positive (HR +), epidermal growth factor. human advanced or metastatic receptor 2 negative (HER2-) breast cancer.
In cell model experiments, RGT-419B demonstrated single agent activity with greater suppression of ER + tumor cell growth compared to abemaciclib and palbociclib. In ER + breast cancer cells with acquired resistance to currently approved CDK4 / 6 inhibitors, RGT-419B has demonstrated complete suppression of cancer cell proliferation. In these experiments, tumor cell suppression of RGT-419B was further enhanced when combined with a selective estrogen receptor degrader or an inhibitor of the PI3K signaling pathway.
As monotherapy and in combination with other approved therapies, RGT-419B will initially be developed for the treatment of patients with HER2-, ER + breast cancer who have primary or acquired resistance to currently approved CDK4 / 6 inhibitors. . As CDK4 / 6 inhibitors gain wide acceptance in clinical practice, refractory and relapsing patients previously treated with CDK4 / 6 inhibitors become a greater and clinically significant unmet medical need. RGT-419B clinical development programs will address this resistance to CDK4 / 6 and other hormone receptor modulation therapies, providing a new opportunity to improve survival and quality of life in patients with breast cancer. breast at an advanced stage of the disease.
RGT-419B is the first of many innovative oncology drugs developed by Regor. Dr. Xiayang Qiu, Founder and CEO of Regor Therapeutics, said: “This milestone marks Regor’s success in entering the field of oncology therapeutics. By obtaining an optimal selectivity profile against multiple CDKs by leveraging Regor’s proprietary CARD platform, this innovative drug enters clinical development in the United States We are delighted with this opportunity to offer new treatment options and differentiated from the many breast cancer patients around the world.
About breast cancer
HER2-, HR + breast cancer is the most common type of breast cancer. Globally, breast cancer is one of the most common cancers affecting an estimated 2.3 million women in 2020 and is the leading cause of cancer death in women. In China breast cancer is in 4th placee among solid tumor types with more than 400,000 new cases per year. Breast cancer is a huge health burden in China and across the world as well as having a significant negative impact on patients and their families.
About the Regor Therapeutic Group
Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated drugs by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) platform. The company mainly focuses 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 built a new, highly effective drug innovation engine to enable the discovery and development of the best and first-in-class molecules. For more information, please click www.regor.com
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SOURCE Regor Therapeutics