Kronos Bio Inc. (NASDAQ:BIO) Receives FDA Approval for KB-0472 IND in MYC-Amplified Cancers

Kronos Bio Inc. (NASDAQ:BIO) has announced that it has received FDA clearance for its Investigational New Drug (IND) submission for KB-0742, its highly selective and oral inhibitor of cyclin-dependent kinase 9 (CDK9).

KB-0742 is an oral CDK9 inhibitor

The company is planning to commence Phase 1/2 KB-0742 clinical studies in advanced solid tumor patients in Q1 2021. Norbert Bischofberger, the company’s CEO stated that CDK9 is a vital transcriptional MYC co-factor. It is a well-known cancer driver that is amplified in almost 30% of advanced solid tumors. He said that the FDA clearance for the KB-0472 IND is an important milestone for the program that was generated using the company’s proprietary drug discovery platform.

Norbert said that Kronos will initiate first-in-human clinical studies in the coming months designed to determine a dose and schedule. This affords an ideal target engagement and appropriate safety which will set the stage for the more possible development of the promising experimental therapy.

Kronos to study KB-0472 in two clinical study stages

Kronos will conduct the open-label Phase 1/2 KB-0742 clinical study in two stages which include expansion and dose escalation. Most importantly the dose-escalation phase will evaluate KB-0472’s pharmacokinetic (PK), pharmacodynamics, and safety profile. The stage will also determine the pharmacologically active dose and schedule with an ideal safety profile.

The company will study the dose and schedule in the expansion phase in patients having MYC-amplified solid tumors as well as other transcriptionally dependent rare tumors like chordomas and sarcomas. Kronos will report the preliminary PK, PD, and safety data from the study’s dose-escalation phase in 2021.

KB-0742 is a CDK9 inhibitor the company’s developing from MYC-amplified solid tumors treatment. It is important to note that CDK9 is a global transcription regulator essential in MYC expression and function. It is a well-known transcription factor and a recognized cancer driver amplified in patients with solid tumors affecting ovaries, lungs, breast, esophagus, pancreas, liver, and stomach. Kronos Bio generated and optimized KB-0742 from a compound identified using its proprietary small molecule microarray screening platform.