Kronos Bio Announces First Patient Dosed in Phase 1b/2 Clinical Trial of Lanraplenib in Combination with Gilteritinib in Acute Myeloid Leukemia
August 22 2022 - 8:00AM
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 a Phase 1b/2 clinical
trial of lanraplenib in combination with gilteritinib in patients
with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML).
Lanraplenib is the company’s next-generation
spleen tyrosine kinase (SYK) inhibitor. In addition to lanraplenib,
Kronos Bio is also evaluating its lead investigational SYK
inhibitor, entospletinib, in the Phase 3 registrational AGILITY
study as a treatment for newly diagnosed patients with NPM1-mutated
AML in combination with standard induction and consolidation
chemotherapy. While entospletinib and lanraplenib have equivalent
preclinical anti-leukemic activity and selectivity for SYK,
lanraplenib’s pharmacologic properties may be advantageous in
regimens that are dosed to progression, such as the investigational
gilteritinib combination.
The Phase 1b/2 lanraplenib clinical trial is a
multi-center, open-label, dose-escalation study enrolling patients
with relapsed/refractory FLT3-mutated AML. This trial is being
conducted in two stages: a dose-escalation stage and an expansion
stage. The first stage is evaluating initial safety,
pharmacokinetic and anti-leukemic activity of escalating once-daily
doses of lanraplenib in combination with the standard approved dose
of gilteritinib. This stage also will assess FLT3 measurable
residual disease (MRD) negative rate in patients who achieve a
complete response (CR) and explore the predictive value of a number
of biomarkers that may correlate with clinical outcomes.
Once a recommended dose is established, an
expansion stage is planned to further evaluate the safety of
lanraplenib and assess its anti-leukemic activity as measured by CR
rate and duration of response.
“The initiation of this study is an important
first step as we advance lanraplenib for patients with certain
genetically defined types of AML,” said Jorge DiMartino, M.D.,
Ph.D., chief medical officer and executive vice president of
Clinical Development at Kronos Bio. “Our long-term vision is to
develop lanraplenib as a cornerstone of targeted regimens for these
patients, allowing us to potentially reach as many as two-thirds of
patients with AML. Today’s announcement represents important
progress toward that goal.”
Kronos Bio currently has three investigational compounds in
clinical development. In addition to the SYK inhibitors, which were
acquired from Gilead Sciences, Inc., the company is advancing
KB-0742, a highly selective, orally bioavailable inhibitor of
cyclin dependent kinase 9 (CDK9) as a treatment for MYC-amplified
solid tumors. KB-0742 is currently being studied in a Phase 1/2
trial and is the first compound discovered through the company’s
proprietary small molecule microarray (SMM) screening platform.
Learn more about Krono Bio’s clinical trials
here.
About Acute Myeloid
LeukemiaAcute myeloid leukemia (AML) primarily affects
adults and is one of the most difficult-to-treat blood cancers. AML
starts in the bone marrow, impairing its ability to produce mature
red blood cells, white blood cells and platelets. Without
treatment, patients die within weeks to months from progressive
bone marrow failure leading to infections, bleeding and heart
failure. Approximately 20,000 people are diagnosed with AML in the
United States each year, with FLT3 genetic mutations found in
approximately one-third of cases. Relapse in AML is common, and
despite available treatments, almost 11,000 people die from the
disease each year in the United States.
About Lanraplenib Kronos Bio is
developing lanraplenib, a next-generation selective inhibitor
targeting spleen tyrosine kinase (SYK), for the treatment of
patients with relapsed/refractory FLT3-mutated acute myeloid
leukemia (AML). Lanraplenib has been investigated in more than 250
healthy volunteers and patients with autoimmune diseases. In
preclinical studies, lanraplenib was shown to have anti-leukemic
activity against NPM1-mutated and FLT3-mutated AML samples.
About Kronos Bio, Inc.Kronos
Bio is a biopharmaceutical company that is advancing three
investigational compounds in clinical trials for patients with
cancer. The company’s lead compound, the SYK inhibitor
entospletinib, is being evaluated in the registrational Phase 3
AGILITY trial as a treatment for patients with newly diagnosed
NPM1-mutated acute myeloid leukemia (AML). The company is also
developing the CDK9 inhibitor, KB-0742, as a treatment for
MYC-amplified solid tumors and lanraplenib, a next-generation SYK
inhibitor being assessed in patients with FLT3-mutated AML. The
company’s scientific focus is on developing medicines that target
the dysregulated transcription that is the hallmark of cancer and
other serious diseases.
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 “goal,” “long-term,” “may,” “plan,” “vision,”
“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: lanraplenib’s
pharmacologic properties and potential advantages; the design of
the Phase 1b/2 lanraplenib clinical trial; future clinical trial
activities and goals; Kronos Bio’s long-term vision for
lanraplenib; 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 progress or complete
any of its ongoing clinical trials on the timelines expected, if at
all, including due to risks inherent in the clinical development of
novel therapeutics; risks related to Kronos Bio’s limited
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 June 30, 2022,
as filed with the SEC on August 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 KottleKronos
Bio650-900-3450mkottle@kronosbio.com
Investors:Claudia StyslingerArgot
Partners212-600-1902kronosbio@argotpartners.com
Media:Sheryl SeapyReal
Chemistry949-903-4750sseapy@realchemistry.com
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