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Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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KB-0742
Solid tumors
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Phase 1/2
Phase 1/2
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Entospletinib
Acute myeloid leukemia (AML)
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Entospletinib
Acute myeloid leukemia (AML)
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Phase 1/2
Phase 1/2
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Phase 1/2 FLT3 mt AML trial to be initiated late-2021.
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Latest News
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Company intends to develop LANRA as a once-daily chronic treatment for genetically-defined AML patients
Two Phase 1/2 clinical trials of LANRA are planned, with first trial to initiate in Q4 2021
SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company's lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.
"This LANRA IND caps off an outstanding year for our SYK portfolio, which we acquired just over a year ago. Since that time, we have nearly completed the integration of the ENTO and LANRA programs with our systems, built out the requisite clinical, translational, regulatory and manufacturing infrastructure for LANRA and ENTO and had successful interactions with the FDA, both for the ENTO Phase 3 clinical trial, as well as for LANRA in relapsed/refractory FLT3-mututated AML patients. The stage is now set to demonstrate the value of SYK inhibition for patients with this life-threatening disease," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, clinical development of Kronos Bio. "Based on the existing clinical data and differentiated pharmacologic properties of ENTO and LANRA, we have designed a complementary development strategy that seeks to maximize the impact of both investigational medicines. ENTO is entering a registrational Phase 3 clinical trial that may support its accelerated approval to treat newly diagnosed NPM1-mutated AML patients in combination with chemotherapy for a defined duration of treatment. LANRA's differentiated pharmacologic properties support its evaluation as a component of more extended combination dosing regimens with gilteritinib or venetoclax/azacitidine, which are dosed to progression. We believe this precision oncology approach will allow us to systematically address patients with genetic mutations present in more than two-thirds of the AML patient population."
This is the first IND for LANRA in an oncology indication. Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases. In preclinical studies, LANRA showed anti-leukemic activity equivalent to ENTO in NPM1-mutated and FLT3-mutated AML patient blood and bone marrow samples. The PK profile of LANRA enables once-daily dosing in the fed or fasted state and is compatible with proton pump inhibitors, suggesting that it may be more suitable than ENTO for chronic treatment paradigms.
The first of the two planned Phase 1/2 clinical trials of LANRA will include a dose-escalation and an expansion cohort study design. The first stage will evaluate initial safety, PK and anti-leukemic activity of escalating once-daily doses of LANRA in combination with the standard approved dose of gilteritinib. This stage also will assess FLT3 measurable residual disease negativity (if any) in patients who achieve a complete response (CR) and explore the predictive value of a number of biomarkers that may correlate with clinical outcomes. Initial data from this first stage of the trial are anticipated to be available in the second half of 2022. Once a recommended dose is established, an expansion cohort of approximately 30 patients is planned to further evaluate the safety of LANRA and assess its anti-leukemic activity as measured by composite CR rate and duration of response. These data are anticipated in the second half of 2023.
In the first half of 2022, Kronos Bio plans to initiate a second Phase 1/2 clinical trial, also involving a dose-escalation and expansion cohort study design of LANRA in combination with venetoclax/azacitidine in patients newly diagnosed with NPM1-mutated and/or FLT3-mutated AML who are older than age 75 or not eligible for intensive induction chemotherapy. Kronos Bio anticipates initial data from this trial in the first half of 2023 and proof-of-concept data from an escalation cohort in late 2023 or early 2024.
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow and can quickly lead to death as a result of bone marrow failure. Approximately 20,000 Americans are diagnosed with AML each year,1 with the NPM1 genetic mutation found in approximately 30% of cases.2 Relapse in AML is common,3 and despite available treatments, nearly 11,000 Americans die from the disease each year.1About Lanraplenib (LANRA)
Kronos Bio is developing LANRA, a next-generation selective inhibitor targeting spleen tyrosine kinase (SYK), for the treatment of patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) and patients newly diagnosed with NPM1-mutated and/or FLT3-mutated AML who are older than 75 years old or are not eligible for intensive induction chemotherapy. LANRA has been investigated in more than 250 healthy volunteers and patients with autoimmune diseases. In preclinical studies, LANRA was shown to have anti-leukemic activity against NPM1-mutated and FLT3-mutated AML samples. The first Phase 1/2 clinical trial for LANRA in AML is scheduled to begin in Q4 2021, with a second Phase 1/2 clinical trial for LANRA in AML scheduled to begin in the first half of 2022.About Entospletinib (ENTO)
Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy. ENTO is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1 (HOX/MEIS).4 Multiple AML driver mutations, including NPM1 and MLL gene rearrangements, have been associated with elevation of HOX/MEIS.5,6 ENTO has been investigated in more than 700 patients with a variety of hematologic malignancies, including AML, with clinical results observed in AML patients with NPM1 and FLT3 mutations and MLL rearrangements that support further development of the therapy.6,7About 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 is developing its portfolio of spleen tyrosine kinase (SYK) inhibitors, comprised of entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-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-dependent 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 "will," "proceed," "plan," "seek," "may," "believe," "potential," "anticipated" and similar words 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 conduct a registrational Phase 3 trial of ENTO in frontline fit NPM1-mutated AML, and the timing thereof, and the trial potentially supporting accelerated approval; Kronos Bio's plans to conduct a Phase 1/2 trial of LANRA in relapsed/refractory FLT3-mutated AML in combination with gilteritinib, and the design and timing thereof; Kronos Bio's plans to conduct a Phase 1/2 trial of LANRA in frontline unfit NPM1-mutated and/or FLT3-mutated AML in combination with venetoclax/azacitidine, and the design and timing thereof; the timing of data from our planned Phase 1/2 trials of LANRA; LANRA's suitability for chronic treatment paradigms; the ability of our development strategy to maximize the impact of ENTO and LANRA; our belief that we can potentially systematically address patients with genetic mutations through our precision oncology approach; 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 current and planned clinical trials of ENTO, LANRA and KB-0742 on the timelines 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; 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 March 31, 2021, filed with the SEC on May 11, 2021. 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
- American Cancer Society. About Acute Myeloid Leukemia (AML). Key Statistics for Acute Myeloid Leukemia (AML). https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html. Accessed March 1, 2021.
- Patel JP, Gönen M, Figueroa ME, et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012;366(12):1079-1089. doi:10.1056/NEJMoa1112304.
- National Institutes of Health. National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html. Accessed March 1, 2021.
- Mohr S, Doebele C, Comoglio F, et al. Hoxa9 and Meis1 cooperatively induce addiction to Syk signaling by suppressing miR-146a in acute myeloid leukemia. Cancer Cell. 2017;31:549-562.
- Tyner JW, Tognon CE, Bottomly D, et al. Functional genomic landscape of acute myeloid leukaemia. Nature. 2018:562:526-531.
- Walker AR, Byrd JC, Bhatnagar B, et al. Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia. Presented at the 23rd Congress of the European Hematology Association; June 15, 2018; Stockholm, Sweden.
- Walker AR, Byrd JC, Blachly JS, et al. Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression. Clin Cancer Res. 2020:26:5852-5859.
Investors:
Claudia Styslinger
Argot Partners
212-600-1902
[email protected]Media:
Sheryl Seapy
Real Chemistry
949-903-4750
[email protected]
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SAN MATEO, Calif., May 26, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that members of the management team will participate in fireside chats at the following investor conferences:
- Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021, at 10:30 a.m. ET; and
- Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9, 2021, at 11:20 a.m. ET.
The fireside chats will be webcast live from the Investors & Media section of the company's website at www.kronosbio.com. A replay of the webcast will be archived and available for one month following the event.
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 is developing a portfolio of spleen tyrosine kinase (SYK) inhibitors, entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-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-dependent 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
[email protected]Investors:
Claudia Styslinger
Argot Partners
212-600-1902
[email protected]Media:
Sheryl Seapy
Real Chemistry
949-903-4750
[email protected] -
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Unveils development strategy for lanraplenib (LANRA), which will expand addressable patient population for SYK inhibitor portfolio in acute myeloid leukemia (AML); plans to initiate two Phase 1/2 trials in late 2021 and early 2022
On track to initiate registrational Phase 3 trial for entospletinib (ENTO) in newly diagnosed NPM1-mutated AML in mid-2021
Outlines potential target indications based on recent preclinical data for CDK9 inhibitor KB-0742, in development to treat MYC-dependent solid tumors; initial safety, PK and PD data readout from ongoing Phase 1/2 trial expected in the fourth quarter of 2021
Highlights unique capabilities of discovery product engine that enables selective targeting of transcription factors and transcriptional regulatory networks that drive cancer
SAN MATEO, Calif. and CAMBRIDGE, Mass., May 25, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, will host a virtual R&D Day today to detail the development strategy for its spleen tyrosine kinase (SYK) inhibitor portfolio, and highlight the momentum of its cyclin-dependent kinase 9 (CDK9) inhibitor program and the company's ability to target transcription factors and transcriptional regulatory networks that drive cancer. The webinar will begin at 1:00 p.m. ET and can be accessed here.
"Transcription factors and their associated regulatory networks have long been known to drive cancerous cell growth but have eluded therapeutic approaches. We are excited to present our progress in understanding and targeting transcriptional regulatory networks that drive small cell lung cancer and castration-resistant prostate cancer. We also look forward to sharing our roadmap for the continued development of novel cancer therapeutics that have the potential to address high unmet needs," said Norbert Bischofberger, Ph.D., president and CEO. "Today, we are announcing our plans to initiate two Phase 1/2 clinical trials for LANRA in patients with relapsed/refractory FLT3-mutated AML and in patients newly diagnosed with NPM1-mutated AML who are not candidates for intensive induction chemotherapy. The LANRA trials build upon the significant progress we have made over the past year, which includes advancing ENTO toward a registrational Phase 3 clinical trial that may support accelerated approval to treat newly diagnosed NPM1-mutated AML patients eligible for intensive induction chemotherapy and initiating a Phase 1/2 clinical trial for KB-0742, our oral CDK9 inhibitor targeting MYC-dependent solid tumors."
"ENTO and LANRA are differentiated clinical-stage SYK inhibitors that have the potential to address patients with mutations present in more than two-thirds of AML. Our development strategy for these complementary therapies seeks to leverage their properties to address the treatment needs of patients – ENTO in the induction setting for a defined duration of therapy and LANRA for potential treatment to progression," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, clinical development. "During today's event, we also look forward to outlining our development strategy for our CDK9 inhibitor KB-0742 and sharing recent preclinical data that highlight the drug's unique properties and potential anti-tumor activity in MYC-dependent cancers that develop in the breast, lungs, stomach and esophagus and in other transcriptionally addicted tumors like sarcoma and chordoma."
Select R&D Day Highlights
Unveils SYK Inhibitor Portfolio Development Strategy
Kronos Bio will unveil the development strategy for the company's SYK inhibitor portfolio comprised of differentiated clinical-stage inhibitors ENTO and LANRA. The strategy will leverage the unique pharmacological properties of each inhibitor to expand the potential impact of SYK inhibition in AML beyond patients who are newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy.The company's SYK inhibitor portfolio, in combination with standard of care backbone regimens, could ultimately address both fit and unfit newly diagnosed AML patients with NPM1 and/or FLT3 mutations. In addition, rational combinations of SYK inhibitors with other targeted agents in the relapsed/refractory setting may eventually provide new treatment options for patients with genetically defined subtypes of AML. Specifically, the company plans to initiate the following trials:
- Mid-2021 – Registrational Phase 3 trial for ENTO in patients who are newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy
- Late 2021 – Phase 1/2 trial for LANRA in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated AML
- Early 2022 – Phase 1/2 trial for LANRA in combination with venetoclax/azacitidine in patients with newly diagnosed NPM1-mutated and/or FLT3-mutated AML who are older than 75 years old or are not eligible for intensive induction chemotherapy
The company's development strategy seeks to maximize the impact of these complementary investigational therapies, which have the potential to address patients with mutations present in more than two-thirds of AML.
Identifies KB-0742 Potential Target Indications Based on Additional Preclinical Data
The company will outline potential target indications for KB-0742, a highly selective, orally bioavailable CDK9 inhibitor in development to treat MYC-dependent, including MYC-amplified, solid tumors and other transcriptionally addicted cancers, based on recent preclinical data demonstrating activity in several tumor types. These data build upon research presented at the 2021 American Association for Cancer Research Annual Meeting that showed CDK9 inhibition on an intermittent dosing schedule resulted in sustained inhibition of tumor growth in multiple cancers.The company plans to share initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from dose escalation cohorts of the Phase 1/2 clinical trial in the fourth quarter of 2021. Following these data, which will be used to establish a recommended dose and schedule, the company plans to initiate testing in expansion cohorts to assess KB-0742's anti-tumor activity in non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer, gastric/gastroesophageal cancer and in other transcriptionally addicted tumors such as sarcoma and chordoma.
Highlights Unique Capabilities of Discovery Product Engine
Today, Kronos Bio will highlight the unique aspects of its product engine that support the mapping of the transcriptional regulatory networks that drive tumor subtypes and response to treatment, which is critical to discovery efforts. The company will also explain how its small molecule microarray (SMM) screening platform, a key component of its product engine, allows for the identification of highly selective compounds, and will discuss how continuous optimization of the SMM platform for throughput and quality results in a versatile product engine that may allow for the targeting of transcription factors using multiple modalities.Virtual R&D Day Agenda
The following topics and speakers will be featured at Kronos Bio's Virtual R&D Day (all times are Eastern Time):1:00 – 1:10 p.m.
Welcome and Introduction
Norbert Bischofberger, Ph.D., President and CEO1:10 – 1:30 p.m.
Acute Myeloid Leukemia in 2021
Eytan M. Stein, M.D., Director, Program for Drug Development in Leukemia, Leukemia Service, Memorial Sloan Kettering Cancer Center1:30 – 2:00 p.m.
SYK Inhibition: An opportunity to address mutations present in more than 2/3 of AML
Jorge DiMartino, M.D., Ph.D., Chief Medical Officer and EVP, Clinical Development
Yasir Al-Wakeel, BM BCh, Chief Financial Officer and Head of Corporate Development2:00 – 2:20 p.m.
Q&A Session #12:20 – 2:30 p.m.
Break2:30 – 3:00 p.m.
CDK9 Inhibition: An opportunity to target the master regulator MYC
Jorge DiMartino3:00 – 3:30 p.m.
Discovery Pipeline: Maximizing the value of our platform
Charles Lin, Ph.D., SVP, Biology
Christopher Dinsmore, Ph.D., Chief Scientific Officer3:30 – 3:50 p.m.
Q&A Session #23:50 – 4:00 p.m.
Summary and Close
Yasir Al-WakeelVirtual R&D Day Webcast Information
The live webcast will begin at 1:00 p.m. ET and conclude at approximately 4:00 p.m. ET. The webcast is accessible from the Investors & Media section of the company's website at www.kronosbio.com. A replay of the event will be available for a limited time on Kronos Bio's website.About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow and can quickly lead to death as a result of bone marrow failure. Approximately 20,000 Americans are diagnosed with AML each year,1 with the NPM1 genetic mutation found in approximately 30% of cases.2 Relapse in AML is common,3 and despite available treatments, nearly 11,000 Americans will die from the disease each year.1About Entospletinib (ENTO)
Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy. ENTO is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1 (HOX/MEIS).4 Multiple AML driver mutations, including NPM1 and MLL gene rearrangements, have been associated with elevation of HOX/MEIS.5,6 ENTO has been investigated in more than 700 patients with a variety of hematologic malignancies, including AML, with clinical results observed in AML patients with NPM1 and FLT3 mutations and MLL rearrangements that support further development of the therapy.6,7About Lanraplenib (LANRA)
Kronos Bio is developing LANRA, a next-generation selective inhibitor targeting spleen tyrosine kinase (SYK), for the treatment of patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) and patients newly diagnosed with NPM1-mutated and/or FLT3-mutated AML who are older than 75 years old or are not eligible for intensive induction chemotherapy. LANRA has been investigated in more than 250 patients with autoimmune diseases. In preclinical studies, LANRA was shown to have anti-leukemic activity against NPM1-mutated and FLT3-mutated AML samples. Two Phase 1/2 clinical trials for LANRA in AML are scheduled to begin in late 2021 and early 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-dependent, including 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.8 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 is developing a portfolio of spleen tyrosine kinase (SYK) inhibitors, entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-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-dependent 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 "progress," "expected," "look forward," "unveil," "proceed," "assess," "plans," "initiate," "developed," "provide," "planned," "expectations" "anticipated," 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 conduct a registrational Phase 3 trial of ENTO in frontline fit NPM1-mutated AML, and the timing thereof; Kronos Bio's plans to conduct a Phase 1/2 trial for LANRA in relapsed/refractory FLT3-mutated AML in combination with gilteritinib, and the timing thereof; Kronos Bio's plans to conduct a Phase 1/2 trial for LANRA in frontline unfit NPM1-mutated and/or FLT3-mutated AML in combination with venetoclax/azacitidine, and the timing thereof; the timing of the initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from dose escalation cohorts of Kronos Bio's Phase 1/2 clinical trial of KB-0742; potential target indications for KB-0742; Kronos Bio's plans to initiate testing in expansion cohorts to assess KB-0742's anti-tumor activity in small cell lung cancer, non-small cell lung cancer, triple-negative breast cancer, gastric/gastroesophageal cancer and transcriptionally addicted tumors such as sarcoma and chordoma; 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 current and planned clinical trials of ENTO, LANRA and KB-0742 on the timelines 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; 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 March 31, 2021 filed with the SEC on May 11, 2021. 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
- American Cancer Society. About Acute Myeloid Leukemia (AML). Key Statistics for Acute Myeloid Leukemia (AML). https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html. Accessed March 1, 2021.
- Patel JP, Gönen M, Figueroa ME, et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012;366(12):1079-1089. doi:10.1056/NEJMoa1112304.
- National Institutes of Health. National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html. Accessed March 1, 2021.
- Mohr S, Doebele C, Comoglio F, et al. Hoxa9 and Meis1 cooperatively induce addiction to Syk signaling by suppressing miR-146a in acute myeloid leukemia. Cancer Cell. 2017;31:549-562.
- Tyner JW, Tognon CE, Bottomly D, et al. Functional genomic landscape of acute myeloid leukaemia. Nature. 2018:562:526-531.
- Walker AR, Byrd JC, Bhatnagar B, et al. Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia. Presented at the 23rd Congress of the European Hematology Association; June 15, 2018; Stockholm, Sweden.
- Walker AR, Byrd JC, Blachly JS, et al. Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression. Clin Cancer Res. 2020:26:5852-5859.
- 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
[email protected]Investors:
Claudia Styslinger
Argot Partners
212-600-1902
[email protected]Media:
Sheryl Seapy
Real Chemistry
949-903-4750
[email protected] -
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Virtual R&D Day on May 25 to unveil SYK portfolio development strategy and highlight momentum of CDK9 inhibitor program and differentiated drug discovery platform
Preclinical data for KB-0742 presented at the American Association for Cancer Research (AACR) Annual Meeting demonstrated sustained inhibition of tumor growth in multiple cancers
$440.6 million in cash, cash equivalents and investments as of March 31, 2021
SAN MATEO, Calif. and CAMBRIDGE, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and first quarter financial results.
"With continued progress in our preclinical and clinical programs and significant milestones expected this year, we look forward to hosting a research and development day to present our pipeline and unveil our development strategy for both of our clinical-stage SYK inhibitors entospletinib and lanraplenib," said Norbert Bischofberger, Ph.D., president and CEO. "We recently showcased progress with our CDK9 program at the AACR annual meeting in April, where we presented preclinical data indicating that KB-0742 could have utility in the treatment of MYC-amplified cancers. We look forward to sharing more about our development plans for this compound at our research and development day."
Dr. Bischofberger added: "I would also like to take this opportunity to reflect on the recent passing of our Board Member, Dr. John C. Martin, a dear friend and mentor, and to convey our deepest sympathies to John's family and everyone who was fortunate enough to have known him."
Recent Highlights
- Presented preclinical data for KB-0742, the company's potent oral, highly selective cyclin dependent kinase 9 (CDK9) inhibitor, at the American Association for Cancer Research (AACR) Annual Meeting. The data showed that CDK9 inhibition on an intermittent dosing schedule with KB-0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors, and suggested that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, is a key feature in defining sensitivity to CDK9 inhibition.
- Announced the appointment of Taiyin Yang, Ph.D., to its board of directors. Dr. Yang currently serves as the executive vice president of Pharmaceutical Development and Manufacturing at Gilead Sciences, Inc., and has more than four decades of experience developing and manufacturing medicines in a variety of therapeutic categories.
- Announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for spleen tyrosine kinase (SYK) inhibitor entospletinib. Kronos Bio will proceed with its plan to assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint in a registrational Phase 3 trial to support potential accelerated approval of entospletinib in patients newly diagnosed with NPM1-mutated acute myeloid leukemia (AML). The company plans to initiate the Phase 3 trial in mid-2021, with MRD negative CR data expected in the second half of 2023.
- Announced the first patient was dosed in the Phase 1/2 clinical trial of KB-0742, which is being developed to treat MYC-amplified solid tumors.
Pipeline updates planned at upcoming Virtual R&D Day on May 25, 2021
- Unveil the development strategy for the company's SYK inhibitors entospletinib and lanraplenib in AML. Kronos Bio executives will be joined by Eytan M. Stein, M.D., assistant attending physician and director, Program for Drug Development in Leukemia, Leukemia Service, Department of Medicine at Memorial Sloan Kettering Cancer Center, who will provide an overview of AML and the current treatment landscape.
- Highlight the opportunity to target MYC through CDK9 inhibition with KB-0742, including a review of preclinical data, expectations for initial safety, pharmacokinetic and pharmacodynamic data anticipated in the fourth quarter of 2021 and potential populations for the expansion cohorts in the second stage of the company's Phase 1/2 clinical trial.
- Provide an overview of the company's differentiated drug discovery platform and potential future pipeline programs.
The live webinar will begin at 1 p.m. ET on Tuesday, May 25, 2021, and will conclude at approximately 4:00 p.m. ET. Registration is accessible on the Investors & Media section of the company's website at www.kronosbio.com. A replay of the webcast will be archived and available following the event.
First Quarter Financial Highlights
Cash, Cash Equivalents and Investments: As of March 31, 2021, cash, cash equivalents and investments totaled $440.6 million.
R&D Expenses: Research and development expenses were $17.6 million for the first quarter of 2021, which includes $2.5 million in non-cash stock-based compensation expense. R&D expenses for the quarter were primarily driven by costs associated with initiating and conducting the company's clinical trials.
G&A Expenses: General and administrative expenses were $8.6 million for the first quarter of 2021, which includes $2.7 million in non-cash stock-based compensation expense.
Net Loss: Net loss for the first quarter of 2021 was $26.1 million, or $0.48 per share, including non-cash stock-based compensation expense of $5.2 million.
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 "progress," "expected," "look forward," "unveil," "proceed," "assess," "plans," "initiate," "developed," "provide," "planned," "expectations" "anticipated," 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 conduct 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 plans to conduct a Phase 3 trial of entospletinib in NPM1-mutated AML, and the 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 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 Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 23, 2021. 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.Kronos Bio, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)Three months ended March 31, 2021 2020 Operating expenses: Research and development $ 17,594 $ 6,195 General and administrative 8,584 1,154 Total operating expenses 26,178 7,349 Loss from operations (26,178 ) (7,349 ) Other income (expense), net: Interest expense — (1 ) Interest and other income, net 92 355 Total other income (expense), net 92 354 Net loss (26,086 ) (6,995 ) Other comprehensive income (loss): Net unrealized gain (loss) on available-for-sale securities (4 ) 158 Net comprehensive loss $ (26,090 ) $ (6,837 ) Net loss per share, basic and diluted $ (0.48 ) $ (1.23 ) Weighted-average shares of common stock, basic and diluted 54,152,656 5,694,832 Kronos Bio, Inc.
Selected Balance Sheet Data
(in thousands, except share and per share amounts)
(Unaudited)March 31, 2021 December 31, 2020 Cash, cash equivalents and investments $ 440,608 $ 462,062 Total assets 487,961 511,964 Total liabilities 42,704 46,445 Total stockholders' equity (deficit) 445,257 465,519 Company contact:
Stephanie Yao
Executive Director, Investor Relations and Corporate Communications
650-525-6605
[email protected]Investors:
Claudia Styslinger
Argot Partners
212-600-1902
[email protected]Media:
Sheryl Seapy
Real Chemistry
949-903-4750
[email protected] - Presented preclinical data for KB-0742, the company's potent oral, highly selective cyclin dependent kinase 9 (CDK9) inhibitor, at the American Association for Cancer Research (AACR) Annual Meeting. The data showed that CDK9 inhibition on an intermittent dosing schedule with KB-0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors, and suggested that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, is a key feature in defining sensitivity to CDK9 inhibition.
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SAN MATEO, Calif. and CAMBRIDGE, Mass., May 06, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that members of the management team will participate in a fireside chat at the Bank of America Securities 2021 Health Care Conference on Thursday, May 13, 2021 at 1:15 p.m. ET.
The fireside chat will be webcast live from the Investors & Media section of the company's website at www.kronosbio.com. A replay of the webcast will be archived and available for one month following the event.
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.
Company contact:
Stephanie Yao
Executive Director, Investor Relations and Corporate Communications
650-525-6605
[email protected]Investors:
Claudia Styslinger
Argot Partners
212-600-1902
[email protected]Media:
Sheryl Seapy
Real Chemistry
949-903-4750
[email protected]