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Kronos Bio to Present Pre-Clinical Data at the AACR Virtual Annual Meeting 2021 for KB-0742, an Oral CDK9 Inhibitor Targeting MYC-amplified Cancers

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Kronos Bio, Inc. (Nasdaq: KRON) has announced the presentation of pre-clinical data for KB-0742, a selective CDK9 inhibitor aimed at treating MYC-amplified solid tumors, at the AACR Annual Meeting 2021 from April 10-15. The study indicates that MYC genomic amplification may affect tumor sensitivity to CDK9 inhibition. A Phase 1/2 clinical trial for KB-0742 began earlier this year, with initial safety and pharmacokinetic data expected in Q4 2021, and expansion cohort data anticipated in 2022.

Positive
  • Presentation of pre-clinical study data for KB-0742 at AACR Annual Meeting, indicating potential efficacy in MYC-amplified tumors.
  • Initiation of Phase 1/2 clinical trial for KB-0742, with initial data expected by year-end 2021.
Negative
  • Risks associated with the COVID-19 pandemic that may impact clinical trial progress.
  • Potential lack of predictive reliability from small patient sample size in the Phase 1/2 trial.

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that data from a pre-clinical study of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors, will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2021, which is being held virtually April 10-15.

In the study, researchers conducted several tests to better define molecular sensitivity to transcriptional inhibition by profiling the sensitivity of various tumor types to KB-0742. The findings suggest that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, may serve as an important feature in defining sensitivity to CDK9 inhibition in patients with advanced solid tumors.

The abstract is now available on the AACR Annual Meeting website. Details of the poster presentation are as follows:

Title: CDK9 inhibition is selective for transcriptionally addicted tumors harboring MYC genomic amplifications
Abstract Number: 1141
Session Category: Experimental and Molecular Therapeutics
Session Title: Epigenetic Targets
Virtual Poster Session Date and Time: April 10 at 8:30 a.m. ET

Kronos Bio initiated a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors or non-Hodgkin lymphoma earlier this year. The company expects to report initial safety, pharmacokinetic and pharmacodynamic data from the dose-escalation stage of the study in the fourth quarter of this year. Initial data from the study’s expansion cohorts are expected in 2022.

About KB-0742
KB-0742 is a highly selective, orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9) in development for the treatment of MYC-amplified solid tumors. CDK9 is a global regulator of transcription and plays an essential role in both the expression and function of MYC, a well-characterized transcription factor and a long-recognized driver of cancer that is amplified in approximately 30% of solid tumors, including those affecting the lungs, ovaries, esophagus, breast, stomach, pancreas and liver.1 KB-0742 was generated and optimized from a compound that was identified using the company’s proprietary small molecule microarray (SMM) screening platform.

About the Small Molecule Microarray (SMM) Screening Platform
Kronos Bio leverages its SMM screening platform to conduct high-throughput screens against traditionally undruggable target proteins, in particular transcription factors. The SMM platform directly addresses the historical challenges of targeting transcription factors by screening in conditions that preserve their associated context-dependent structures and multi-protein complexes. Using the company’s library of approximately 240,000 compounds in microarray format on slides, Kronos Bio screens for small molecule binders of the target transcription factor in context-relevant tumor nuclear lysates. Hits derived from SMM screening have the potential to act through a variety of mechanisms against various members of a transcription factor’s complex and, as such, hits are characterized for their ability to selectively modulate an oncogenic transcription factor’s activity as important criteria for further lead selection and optimization.

About Kronos Bio, Inc.
Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer. The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth. Kronos Bio’s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML). The company is also developing KB-0742, an oral inhibitor of cyclin dependent kinase 9 (CDK9), for the treatment of MYC-amplified solid tumors.

Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit www.kronosbio.com or follow the company on LinkedIn.

Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release, in some cases, uses terms such as “expects,” “expected,” “may,” “will” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding Kronos Bio’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the design of the KB-0742 Phase 1/2 clinical trial, including to establish clinical proof of concept to enable potential further development, and other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: whether Kronos Bio will be able to complete the Phase 1/2 clinical trial of KB-0742, including due to risks associated with the COVID-19 pandemic and risks inherent in the clinical development of novel therapeutics; risks related to Kronos Bio’s lack of experience as a company in conducting clinical trials; the risk that results of preclinical studies and early clinical trials are not necessarily predictive of future results; the risk that due to the relatively small number of patients that Kronos Bio plans to dose in the planned Phase 1/2 KB-0742 clinical trial, the results from such trial, once completed, may be less reliable than results achieved in larger clinical trials, which may hinder Kronos Bio’s efforts to further develop and obtain regulatory approval for KB-0742; and risks associated with the sufficiency of Kronos Bio’s cash resources and need for additional capital. These and other risks are described in greater detail in Kronos Bio’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 18, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Except as required by law, Kronos Bio assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

References
1.Schaub FX, Dhankani V, Berger AC, et al. Pan-cancer alterations of the MYC oncogene and Its proximal network across the cancer genome atlas. Cell Syst. 2018:6(3):282-300.

Company contact:
Stephanie Yao
Executive Director, Investor Relations and Corporate Communications
650-525-6605
syao@kronosbio.com

Investors:
Claudia Styslinger
Argot Partners
212-600-1902
kronosbio@argotpartners.com

Media:
Sheryl Seapy
W2O
949-903-4750
sseapy@purecommunications.com


FAQ

What is KB-0742 and its purpose?

KB-0742 is a selective CDK9 inhibitor developed by Kronos Bio to treat MYC-amplified solid tumors.

When will data from the KB-0742 clinical trial be reported?

Initial safety, pharmacokinetic, and pharmacodynamic data from the KB-0742 trial are expected in Q4 2021.

What are the results of the pre-clinical study for KB-0742?

The pre-clinical study suggests that MYC genomic amplification may determine the sensitivity of tumors to CDK9 inhibition.

Where will the KB-0742 pre-clinical data be presented?

Data will be presented at the AACR Annual Meeting 2021, held virtually from April 10-15.

Kronos Bio, Inc.

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