Ranok Therapeutics Announces Initiation of Patient Dosing in a Phase 1/2 Clinical Trial of RNK05047, a First-in-Class BRD4-Targeting CHAMP™ Protein Degrader

On August 24, 2022 Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported the initiation of patient dosing in the U.S. for a Phase 1/2 study of RNK05047 (Press release, Ranok Therapeutics, AUG 24, 2022, View Source [SID1234618616]). The trial, entitled CHAMP-1, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RNK05047 in patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Ranok anticipates preliminary data from the study in the second half of 2023.

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"RNK05047 is Ranok’s first therapy based on our proprietary CHAMP technology, as well as the first BRD4 protein degrader in the pharmaceutical industry to enter clinical testing," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok. "RNK05047 is designed to selectively degrade BRD4 protein preferentially in tumors, thereby improving safety and efficacy, which differentiates it from other investigational therapies such as non-selective BET inhibitors."

"The BET bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types," said Manuel Hidalgo Medina, M.D., Ph.D., Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center, Associate Director of Clinical Services at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a site Principal Investigator in the trial. "We are pleased to be participating in this trial and are hopeful that RNK05047 will provide a beneficial new therapeutic option for patients."

Additional information on this clinical trial (NCT05487170) can be found at www.clinicaltrials.gov.

About Ranok’s CHAMP platform

Ranok’s proprietary Chaperone-mediated Protein Degradation/Degrader (CHAMP) platform and Chaperone-Tether Library 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, such as the evasion of mechanisms of drug resistance, and is designed to 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.