Kronos Bio’s Investigational SYK Inhibitors Entospletinib and Lanraplenib to be Featured in Four Poster Presentations at EHA2022 Congress
Kronos Bio, Inc. (Nasdaq: KRON) announced the presentation of preclinical data on its investigational SYK inhibitors, entospletinib and lanraplenib, at the European Hematology Association 2022 Congress. The Phase 3 AGILITY study of entospletinib in NPM1-mutated acute myeloid leukemia (AML) is underway, with results expected in late 2023. Lanraplenib is being tested in a Phase 1b/2 study for relapsed/refractory AML. Key findings indicate strong predictive markers for entospletinib's efficacy and synergistic effects with other targeted therapies. The company aims to advance its pipeline amid challenging market conditions.
- Kronos Bio is advancing the Phase 3 AGILITY study of entospletinib, expecting data in late 2023.
- Preclinical studies show strong predictive markers for entospletinib's efficacy in AML.
- Synergistic activity of lanraplenib with other agents is demonstrated in targeted models.
- Regulatory approval for novel therapeutics remains uncertain.
- Kronos Bio has limited experience in conducting clinical trials, posing execution risks.
- The company may face challenges related to cash resources and potential need for additional capital.
Posters include preclinical data on SYK inhibition in combination with targeted agents and demonstrate preclinical anti-tumor activity in acute myeloid leukemia (AML)
Additional presentations detail trial designs for Kronos Bio’s Phase 3 registrational study of entospletinib and Phase 1b/2 lanraplenib trial in genetically defined AML
SAN MATEO, Calif. and CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, today announced that its two novel investigational spleen tyrosine kinase (SYK) inhibitors, entospletinib and lanraplenib, will be featured in poster presentations at the European Hematology Association (EHA) 2022 Congress, being held June 9-12 in Vienna.
Kronos Bio is enrolling patients in the registrational Phase 3 AGILITY study of entospletinib in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy in patients with NPM1-mutated acute myeloid leukemia (AML). Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease (MRD) negative complete response.
The company is also advancing lanraplenib, a next generation SYK inhibitor, as a potential treatment for patients with relapsed/refractory AML in combination with gilteritinib in a Phase 1b/2 study. Kronos Bio has begun to open trial sites and plans to initiate dosing of the first patient in the second quarter.
One poster describes the analysis of mutational and gene expression signatures from bone marrow and peripheral blood samples from patients with NPM1-mutated AML, demonstrating that NPM1 mutation, with or without co-mutation of FLT3, is a strong predictor of entospletinib anti-leukemic activity. Additional experiments demonstrated that entospletinib and lanraplenib could restore T-cell proliferation in a subset of AML samples from patients with dysfunctional T-cell responses.
In a second poster, the company shows synergistic activity of lanraplenib in combination with other targeted agents, including gilteritinib in an NPM1-mutated/FLT3-mutated PDX model, supporting ongoing and future clinical studies.
Two additional posters detail the design of the entospletinib and lanraplenib clinical studies.
The abstracts are now available on the EHA website. Details of the poster presentations are as follows:
Poster Title: Pharmacological inhibition of SYK confers anti-proliferative and novel anti-tumor immune responses in AML
Abstract Code: P392
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 p.m. CET
Poster Title: SYK inhibition drives deep responses in a biomarker guided subset of AML alone and in rational combinations
Abstract Code: P428
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 p.m. CET
Poster Title: Phase 1b/2 study on safety, pharmacokinetic, pharmacodynamic and preliminary efficacy of the selective SYK inhibitor lanraplenib in combination with the FLT3 inhibitor gilteritinib in FLT3-mutated relapsed/refractory AML (KB-LANRA 1001)
Abstract Code: P524
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 p.m. CET
Poster Title: Phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of entospletinib added to intensive induction and consolidation chemotherapy in newly diagnosed NPM1-mutated AML
Abstract Code: P525
Date and Time: Friday, June 10, 2022, 4:30 – 5:45 p.m. CET
About Kronos Bio, Inc.
Kronos Bio is an integrated discovery through late-stage clinical development biopharmaceutical company, focused on developing therapies that target the dysregulated transcription that causes cancer and other serious diseases. Kronos Bio’s lead investigational compound is entospletinib, an orally administered, selective inhibitor targeting spleen tyrosine kinase (SYK) in clinical development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML) in combination with intensive chemotherapy. The company is also developing KB-0742, an orally administered inhibitor of cyclin dependent kinase 9 (CDK9), in Phase 1/2 clinical development for the treatment of MYC-amplified or overexpressing 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 “anticipated,” “plans,” “will,” “expect,” “potential” 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 anticipated timing for reporting data; Kronos Bio’s plans and the timing thereof for its planned clinical trial of lanraplenib; the potential for any of Kronos Bio’s product candidates to become a treatment for any disease; 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: risks inherent in the clinical development and obtaining regulatory approval of novel therapeutics; risks related to Kronos Bio’s lack of experience as a company in conducting clinical trials; risks associated with the COVID-19 pandemic; 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, 2022, which was filed with the SEC on May 4, 2022. 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:
Marni Kottle
Senior Vice President, Corporate Communications & Investor Relations
415-218-7111
mkottle@kronosbio.com
Investors:
Claudia Styslinger
Argot Partners
212-600-1902
kronosbio@argotpartners.com
Media:
Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com
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