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Kronos Bio, Inc Announces Positive Data from Ongoing Phase 1/2 Trial of Oral CDK9 Inhibitor KB-0742

11/29/2021 | 07:00am EST

Kronos Bio, Inc. announced positive data from the ongoing Phase 1/2 clinical trial of KB-0742, the company?s internally discovered, highly selective, oral cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors. An interim analysis of the ongoing dose escalation stage of the trial (data cut-off October 29) demonstrated a differentiated pharmacokinetic (PK) profile and evidence of target engagement for KB-0742. The PK analysis showed oral bioavailability and dose-proportional exposure across the first three dose levels, with low to moderate variability between patients. Among the 12 patients treated in the trial, KB-0742 had a terminal half-life of 24 hours, with approximately 2 to 2.5-fold accumulation between Day 1 and Day 10. This long plasma half-life supports Kronos Bio?s approach to defining a therapeutic window for CDK9 inhibition. Proprietary target engagement assays developed and prospectively validated by Kronos Bio demonstrated dose-dependent reduction of phosphorylation of Ser2 on RNA Polymerase II (pSer2), a direct substrate target of CDK9, as well as reduced expression of CDK9-dependent genes in peripheral blood mononuclear cells from patients at each of the three dose levels. Consistent with the company?s preclinical modeling, further dose escalation is required to reach desired levels of CDK9 inhibition. The nature and severity of the adverse events observed has been consistent with what is typically seen among heavily pretreated patients with advanced cancer in Phase 1 trials, and Kronos Bio is continuing to enroll the trial. The trial consists of two stages. The first and ongoing stage is assessing the safety, PK and PD profile of KB-0742. This dose escalation stage is designed to define, as efficiently as possible, the recommended Phase 2 dose (RP2D) and schedule and is not specifically enrolling patients based on MYC status, which would lengthen the timeline. The second stage of the trial will enroll patients with MYC-amplified or over-expressing tumors, as well as other transcriptionally addicted tumor types to assess the anti-tumor activity of KB-0742 at the RP2D.

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Financials (USD)
Sales 2021 - - -
Net income 2021 -144 M - -
Net cash 2021 178 M - -
P/E ratio 2021 -3,68x
Yield 2021 -
Capitalization 563 M 563 M -
EV / Sales 2021 -
EV / Sales 2022 -
Nbr of Employees 95
Free-Float -
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Kronos Bio, Inc. Technical Analysis Chart | KRON | US50107A1043 | MarketScreener
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Norbert W. Bischofberger President, Chief Executive Officer & Director
Yasir B. Al-Wakeel CFO & Head-Corporate Development
Arie S. Belldegrun Chairman
Jorge DiMartino Chief Medical Officer & EVP-Clinical Development
Christopher Dinsmore Chief Scientific Officer
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