Benzinga | Dec 7, 2020 08:03AM EST

Kronos Bio Announces FDA Clearance Of Investigational New Drug Application For KB-0742, An Oral CDK9 Inhibitor Targeting MYC-amplified Cancers

MYC amplification found in approximately 30% of solid tumors



Phase 1/2 clinical trial to begin in the first quarter of 2021

KB-0742 generated using the company's proprietary small molecule microarray (SMM) screening platform

SAN MATEO, Calif., and CAMBRIDGE, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) application for KB-0742, a highly selective, orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9). The company plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors in the first quarter of 2021.

"CDK9 is an important transcriptional co-factor of MYC, a well-known driver of cancer that is amplified in approximately 30 percent of solid tumors," said Norbert Bischofberger, Ph.D., president and CEO. "FDA clearance of the IND for KB-0742 marks an important milestone for this program, which was generated using our proprietary drug discovery platform. In the next few months, we look forward to initiating a first-in-human clinical trial designed to define a dose and schedule which affords appropriate target engagement and acceptable safety, setting the stage for potential further development of this promising investigational therapy."

The open-label, Phase 1/2 clinical trial for KB-0742 will be conducted over two stages: dose escalation and expansion. The dose-escalation stage will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of KB-0742 and seek to establish a pharmacologically active dose and schedule with an acceptable safety profile. This dose and schedule will be further studied in the subsequent expansion stage in patients with MYC-amplified solid tumors and other transcriptionally addicted rare tumors such as sarcomas and chordomas. Kronos Bio expects to report initial safety, PK and PD data from the dose-escalation stage of the study in 2021.