Ranok Therapeutics Announces U.S. FDA Clearance to Proceed with its First-in-Human Trial
2022-01-24 · Ranok Therapeutics (Hangzhou) Co., Ltd. · original ranoktherapeutics.com ↗
- An important milestone for the first protein degrader developed using Ranok’s innovative CHAMP™ technology, with clinical enrollment expected to begin in the first half of 2022 BOSTON, MA and HANGZHOU, China – January 24, 2022 – Ranok Therapeutics, a biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for RNK05047, a novel treatment for patients with advanced solid tumors and lymphomas. Ranok expects to begin enrollment of the Phase 1/2 study entitled CHAMP-1 in the first half of 2022. RNK05047 is a first-in-class, small-molecule, BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP™ (Chaperone-mediated Protein Degradation). This technology leverages the company’s expertise in protein homeostasis and the cellular chaperone network to degrade disease-associated proteins, and is designed to increase drug safety and efficacy through selective targeting of disease tissues. “We are looking forward to initiating this clinical study of the first small-molecule therapy based on our CHAMP™ platform technology,” said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok Therapeutics. “The bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types. RNK05047 is designed to selectively degrade BRD4 protein in a tumor-targeted fashion, which differentiates it from other investigational therapies. We are optimistic that RNK05047 will provide a beneficial new therapeutic option for patients.” About Ranok's CHAMP™ platform Ranok’s proprietary Chaperone-mediated Protein Degradation/Degrader (CHAMP™) platform and Chaperone-Tether LibraryTM are based on our founders’ extensive backgrounds researching protein homeostasis. CHAMP™ technology takes advantage of the cellular chaperone network, which regulates the folding and stability of proteins, distinguishing it from other targeted protein degradation approaches. CHAMP™ has a number of unique advantages, including improved safety and efficacy due to the selective targeting of disease tissues. About RNK05047 RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP™. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase 1/2 trial of RNK05047 currently underway in the U.S. that will assess its safety, tolerability and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. Preliminary data is expected from the trial in the second half of 2023. About Ranok Therapeutics Ranok is a privately held biopharmaceutical company that is pioneering CHAMP, an innovative approach to targeted protein degradation for the discovery and development of novel therapeutics. Our R&D team brings deep biological insight and chemistry expertise to rapidly identify and advance CHAMP degraders for a variety of important disease targets, with the goal to create transformative medicines that benefit patients around the world suffering from cancer and other serious diseases. For more information, please visit the company website at www.ranoktherapeutics.com or follow us on Twitter (@RanokTx) and LinkedIn . US Media & Investor Contact: Ms. Beth Kurth Conway Communications [email protected] China Media & Investor Contact: Dr. Liang Ma Ranok Therapeutics [email protected]
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