KRON Kronos Bio Inc.

29.07
-0.08  -0%
Previous Close 29.15
Open 29.2
52 Week Low 25.5006
52 Week High 39.605
Market Cap $1,628,893,961
Shares 56,033,504
Float 38,744,010
Enterprise Value $1,601,638,564
Volume 41,036
Av. Daily Volume 187,069
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
KB-0742
Solid tumors
Phase 1/2
Phase 1/2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Entospletinib
Acute myeloid leukemia (AML)
Phase 1/2
Phase 1/2
Phase 1/2 FLT3 mt AML trial to be initiated 2021.
Entospletinib
Acute myeloid leukemia (AML)
Phase 2/3
Phase 2/3
Phase 2/3 trial to be initiated 2021.

Latest News

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

    Initial safety, pharmacokinetic and pharmacodynamic data expected in fourth quarter of 2021

    SAN MATEO, Calif. and CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in the Phase 1/2 clinical trial of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors.

    "KB-0742 represents a promising new approach to treating cancers that are transcriptionally addicted to MYC. We are excited to have initiated…

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

    Initial safety, pharmacokinetic and pharmacodynamic data expected in fourth quarter of 2021

    SAN MATEO, Calif. and CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in the Phase 1/2 clinical trial of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors.

    "KB-0742 represents a promising new approach to treating cancers that are transcriptionally addicted to MYC. We are excited to have initiated our clinical development program for KB-0742, which emerged from our internal discovery research efforts and moved quickly into clinical testing in under two years," said Norbert Bischofberger, Ph.D., president and CEO. "We believe KB-0742 has the potential to be a meaningful advance in the treatment of MYC-amplified cancers, which represent approximately 30% of solid tumors."

    "MYC is one of the most sought-after targets in oncology but has eluded therapeutic treatment. Scientific research has established that MYC requires CDK9 to drive its own expression and to drive expression of its target genes. At Kronos Bio, we have observed that tumor cell lines that have extra copies of the MYC gene have heightened sensitivity to KB-0742," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, clinical development. "With KB-0742's high selectivity for CDK9 and oral bioavailability, we have a unique opportunity in this Phase 1/2 clinical trial to investigate an optimal dose and schedule designed to provide appropriate target engagement and acceptable safety that could allow us to leverage CDK9 inhibition as an approach to treating MYC-amplified cancers."

    The open-label, multi-center Phase 1/2 clinical trial of KB-0742 is expected to enroll approximately 100 patients with advanced solid tumors or non-Hodgkin lymphoma. The trial 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 will 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 cancers including soft tissue sarcomas.

    Kronos Bio expects to report initial safety, PK and PD 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, developing and commercializing 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 "believe," "potential," represents," "opportunity, "could," "allow," "expects," "expected," "will," "seek," "further" 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, F.X., Dhankani, V., Berger, A.C., et al. (2018). Pan-cancer Alterations of the MYC Oncogene and Its Proximal Network across the Cancer Genome Atlas. Cell Systems, 6(3), 282–300.

    Company contact:

    Stephanie Yao

    Executive Director, Investor Relations and Corporate Communications

    650-525-6605

    Investors:

    Claudia Styslinger

    Argot Partners

    212-600-1902

    Media:

    Sheryl Seapy

    W2O

    949-903-4750



    Primary Logo

    View Full Article Hide Full Article
  2. SAN MATEO, Calif. and CAMBRIDGE, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced participation in the Cowen 41st Annual Health Care Conference, a virtual event taking place March 1-4, 2021.

    Kronos Bio President and CEO Norbert Bischofberger, Ph.D., will participate in the "Novel Oncology Targets" panel discussion at the Monday, March 1, at 1:20 p.m. ET. The panel discussion will be available live to conference attendees. Members of the management team will also host meetings with investors on March 2 and March 3.

    About Kronos Bio, Inc.
    Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing…

    SAN MATEO, Calif. and CAMBRIDGE, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced participation in the Cowen 41st Annual Health Care Conference, a virtual event taking place March 1-4, 2021.

    Kronos Bio President and CEO Norbert Bischofberger, Ph.D., will participate in the "Novel Oncology Targets" panel discussion at the Monday, March 1, at 1:20 p.m. ET. The panel discussion will be available live to conference attendees. Members of the management team will also host meetings with investors on March 2 and March 3.

    About Kronos Bio, Inc.

    Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing 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.



    Company contact:

    Stephanie Yao

    Executive Director, Investor Relations and Corporate Communications

    650-525-6605

    Investors:

    Claudia Styslinger

    Argot Partners

    212-600-1902

    Media:

    Sheryl Seapy

    W2O

    949-903-4750



    Primary Logo

    View Full Article Hide Full Article
  3. SAN MATEO, Calif. and CAMBRIDGE, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the appointment of veteran biopharmaceutical executive Marianne De Backer, Ph.D., to the company's board of directors. She has more than two decades of experience in business development and commercial leadership in the healthcare industry. Additionally, the company announced that Rebecka Belldegrun, M.D., has resigned from the board to pursue other opportunities.

    "On behalf of the board of directors and senior management team at Kronos Bio, I am pleased to welcome Marianne to the board. Her significant experience in forging and managing strategic…

    SAN MATEO, Calif. and CAMBRIDGE, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the appointment of veteran biopharmaceutical executive Marianne De Backer, Ph.D., to the company's board of directors. She has more than two decades of experience in business development and commercial leadership in the healthcare industry. Additionally, the company announced that Rebecka Belldegrun, M.D., has resigned from the board to pursue other opportunities.

    "On behalf of the board of directors and senior management team at Kronos Bio, I am pleased to welcome Marianne to the board. Her significant experience in forging and managing strategic partnerships coupled with her broad business and commercial acumen and strong science background will be valuable as the company continues to grow," said Norbert Bischofberger, Ph.D., president and CEO. "I would also like to thank Rebecka for her dedicated service to Kronos Bio. She has provided expert guidance and made numerous contributions to the company since our founding, and we wish her well."

    Dr. De Backer has been a strategist, scientist, business leader, deal maker and corporate investor in the healthcare industry. She has been directly accountable for more than 200 strategic alliances in healthcare, some of which have led to newly approved medicines now available to patients. Dr. De Backer is currently chief business officer and executive vice president, Strategy and Business Development and Licensing, at Bayer AG, and a member of the Executive Committee of Bayer Pharmaceuticals. Before joining Bayer in 2019, she spent more than 20 years at the Johnson & Johnson family of companies. She started as a scientist and scientific group leader, during which time her work resulted in multiple patents. She progressed through commercial positions internationally, including leading a sales and marketing business unit responsible for several therapies, culminating as senior vice president, M&A Operations, Divestitures and Janssen Business Development.

    "Kronos Bio is at an important juncture as it advances toward planned clinical testing of two investigational therapies that have the potential to transform treatment outcomes for patients with cancer," said Dr. De Backer. "I look forward to helping guide the company as it grows and seeks to become the leader in targeting dysregulated transcription."

    Dr. De Backer holds an M.S. in molecular biology from the Vrije Universiteit Brussels, an M.S. in engineering and biochemistry and a Ph.D. in biotechnology from the University of Ghent, and an MBA from the Rotterdam School of Management at Erasmus University. She currently serves on the boards of directors of the Gladstone Foundation and Arrowhead Pharmaceuticals. At Kronos Bio, she will serve as a member of the board of directors' compensation committee.

    About Kronos Bio, Inc.

    Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing 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 "advance toward," "potential," "seeks," "expects," "planned," "should," 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: Kronos Bio's plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors and the expected timing thereof; Kronos Bio's plans to begin clinical testing of entospletinib and the expected timing thereof; 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 initiate or complete the Phase 1/2 clinical trial of KB-0742 and the planned clinical trial of entospletinib on the timeline expected, if at all, 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 the planned Phase 1/2 clinical 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.

    Company contact:

    Stephanie Yao

    Executive Director, Investor Relations and Corporate Communications

    650-525-6605

    Investors:

    Claudia Styslinger

    Argot Partners

    212-600-1902

    Media:

    Sheryl Seapy

    W2O

    949-903-4750



    Primary Logo

    View Full Article Hide Full Article
  4. SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 08, 2020 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the appointment of Pasit Phiasivongsa, Ph.D., as senior vice president, pharmaceutical development. Dr. Phiasivongsa brings more than 20 years of experience in the biopharmaceutical industry overseeing manufacturing processes for novel medicines.

    "I am delighted to welcome Pasit to the leadership team at Kronos Bio," said Norbert Bischofberger, Ph.D., president and CEO. "Pasit has a proven track record of success in devising and executing accelerated manufacturing strategies throughout a product's life cycle, from clinical development to commercial…

    SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 08, 2020 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the appointment of Pasit Phiasivongsa, Ph.D., as senior vice president, pharmaceutical development. Dr. Phiasivongsa brings more than 20 years of experience in the biopharmaceutical industry overseeing manufacturing processes for novel medicines.

    "I am delighted to welcome Pasit to the leadership team at Kronos Bio," said Norbert Bischofberger, Ph.D., president and CEO. "Pasit has a proven track record of success in devising and executing accelerated manufacturing strategies throughout a product's life cycle, from clinical development to commercial supply. He will be an instrumental member of our team as we prepare to begin clinical testing of KB-0742, our CKD9 inhibitor, and initiate our planned pivotal trial for entospletinib, our SYK inhibitor, next year."

    Dr. Phiasivongsa has extensive experience overseeing chemistry, manufacturing and controls (CMC) development strategies and advancing programs from proof-of-concept validation through commercial production. He most recently served as senior vice president, technical operations, at Principia Biopharma, a Sanofi company, where he led all CMC development, manufacturing and supply chain-related activities and built the company's technical operations organization. Prior to Principia, he was vice president, pharmaceutical development, at Tobira Therapeutics (acquired by Allergan), where he was responsible for CMC, technical operations and supply chain activities, and led the intellectual property strategy and development for the company's core assets. Earlier in his career, he held positions in drug discovery, development and manufacturing at Dynavax Technologies; Onyx Pharmaceuticals, an Amgen subsidiary; Proteolix, Inc. (acquired by Onyx Pharmaceuticals); Astex Pharmaceuticals (formerly SuperGen, Inc.); and Optimer Pharmaceuticals. He began his career as a research assistant at Cell Pathways, Inc.

    "I am thrilled to be joining Kronos Bio at this transformative time when the company will soon commence clinical testing of two investigational therapies," said Dr. Phiasivongsa. "I look forward to working with the team to advance our current programs and guide pharmaceutical development strategy for the future. Together, we have an exceptional opportunity to improve patients' lives."

    Dr. Phiasivongsa holds a B.S. in biochemistry and a Ph.D. in pharmaceutical and chemical sciences from the University of the Pacific. He is listed on 26 U.S.-issued patents and more than 30 patent applications.

    About Kronos Bio, Inc.

    Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing 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," "planned," "prepare," "begin," "initiate," "commence," "look forward," "guide," "intends," "will," "should," "seek" 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: Kronos Bio's plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors and the expected timing thereof; the design of such planned 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 initiate or complete the Phase 1/2 clinical trial of KB-0742 and the planned clinical trial of ENTO on the timeline expected, if at all, 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 the planned Phase 1/2 clinical 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.

    Contact:

    Stephanie Yao

    Executive Director, Investor Relations and Corporate Communications

    650-525-6605



    Primary Logo

    View Full Article Hide Full Article
  5. 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…

    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.

    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 the expression and function of MYC, a well-characterized transcription factor and a long-recognized driver of cancer that is amplified in approximately 30 percent of solid tumors, including those affecting the lungs, ovaries, esophagus, breast, stomach, pancreas and liver. KB-0742 was generated and optimized from a compound that was identified using the company's proprietary small molecule microarray (SMM) screening platform.

    About Kronos Bio, Inc.

    Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing 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 "designed," "look forward," "promising," "believes," "potential," "expects," "plans," "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: Kronos Bio's plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumors and the expected timing thereof; the design of such planned Phase 1/2 clinical trial, including to establish clinical proof of concept to enable potential further development; Kronos Bio's expectation to report data from such planned Phase 1/2 clinical trial and the expected timing thereof; 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 initiate or complete the Phase 1/2 clinical trial of KB-0742 on the timeline expected, if at all, 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 clinical trial, the results from the planned Phase 1/2 clinical 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.

    Contact:

    Stephanie Yao

    Executive Director, Investor Relations and Corporate Communications

    650-525-6605



    Primary Logo

    View Full Article Hide Full Article
View All Kronos Bio Inc. News