Ranok Therapeutics Announces U.S. FDA Clearance to Proceed With Its First-in-Human Trial of RNK05047 in Patients With Advanced Solid Tumor Cancers and Lymphomas (CHAMP-1)

On 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, reported 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 (Press release, Ranok Therapeutics, JAN 24, 2022, View Source [SID1234606737]). Ranok expects to begin enrollment of the Phase 1/2 study entitled CHAMP-1 in the first half of 2022.

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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."