Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, is
presenting preclinical data that demonstrate anti-leukemic activity
of the investigational spleen tyrosine kinase (SYK) inhibitor,
lanraplenib, in combination with multiple targeted agents in
patient-derived cell isolates and cell lines at the 64th American
Society of Hematology (ASH) Annual Meeting & Exposition in New
Orleans. The data are being shared as part of a poster
presentation.
Lanraplenib is a next-generation SYK inhibitor
that is currently being evaluated in combination with gilteritinib
in patients with relapsed/refractory FLT3-mutated acute myeloid
leukemia (AML) in a Phase 1b/2 study. The company anticipates
sharing initial data from the lanraplenib/gilteritinib trial, along
with the recommended Phase 2 dose (RP2D), in the fourth quarter of
2023 or first quarter of 2024.
Researchers evaluated lanraplenib and a second
SYK inhibitor, entospletinib, which the company has discontinued
developing, in combination with a menin inhibitor (SNDX5613), in
two cell lines with FLT3 internal tandem duplication/MLL
rearrangement. Synergistic anti-proliferative effects were observed
across a broad range of concentrations. The combination triggered
differentiation and apoptosis, suggesting a more complete blockade
of the HOXA9/MEIS1 transcriptional program through synergistic
inhibition by orthogonal mechanisms.
Additionally, the researchers evaluated
synergistic activity of lanraplenib with the FLT3 inhibitor,
gilteritinib, and BCL2 inhibitor, venetoclax, in patient-derived
AML isolates. This analysis found synergistic anti-proliferative
activity for both combinations. Patient-derived xenograft (PDX)
studies also demonstrated deeper reductions in leukemic burden in
the peripheral blood and bone marrow after 28 days of treatment
with lanraplenib and gilteritinib. In a follow-up PDX study with an
optimized regimen, the combination significantly extended overall
survival compared to either single agent.
“These data further support the biological
rationale for SYK inhibition as a treatment for AML,” said Jorge
DiMartino, M.D., Ph.D., chief medical officer and executive vice
president of Clinical Development for Kronos Bio. “We believe that
lanraplenib has the potential to one day be the cornerstone of
targeted therapy-based regimens for the treatment of genetically
defined AML, and these data add to the evidence that supports that
belief.”
Kronos Bio also presented two posters at the
meeting focused on increasing the understanding of measurable
residual disease (MRD) negative CR as a surrogate endpoint in AML
trials. One poster analyzed MRD and survival data from 1,128
patients with NPM1-mutated AML in three cooperative group trials,
confirming that achieving MRD negative CR predicts better overall
and event-free survival. A second poster described the development
of a next generation sequencing-based assay for measuring MRD and
compared the performance of this assay against the gold standard
RT-qPCR based method.
“Kronos Bio has been an industry leader in
pioneering the use of MRD in the development of novel treatments
for patients with AML in a more efficient manner,” said Dr.
DiMartino. “We believe that our continued efforts in this space
will help to advance the field and our own AML pipeline.”
Presentation informationPoster
Title: SYK Inhibitors, Entospletinib and Lanraplenib, Show
Potent Anti-Leukemic Activity in Combination with Targeted
Agents Abstract Number: 2639Date and
Time: Sunday, December 11, 2022, 6-8 p.m. CT
Additional posters
Poster Title: Analysis of Patient-Level Data
From 3 Cooperative Group Trials Confirms a Survival Advantage for
NPM1m Patients Achieving MRD-Negative CR after Intensive Induction
Abstract Number: 2799Date and
Time: Sunday, December 11, 2022, 6-8 p.m. CT
Poster Title: Development of a
Standardized, DNA-Based Next Generation Sequencing Assay for
Assessment of Measurable Residual Disease (MRD) in Acute Myeloid
Leukemia (AML) as the Primary Endpoint in the AGILITY
StudyAbstract Number: 1463Date and
Time: Saturday, December 10, 2022, 5:30-7:30 p.m. CT
About Kronos Bio, Inc.
Kronos Bio is a biopharmaceutical company that
is advancing two investigational compounds in clinical trials for
patients with cancer. The company is developing the CDK9 inhibitor,
KB-0742, as a treatment for MYC-amplified solid tumors, and
lanraplenib, a next-generation SYK inhibitor, for patients with
relapsed/refractory FLT3-mutated acute myeloid leukemia. 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. This press release, in some cases,
uses terms such as “to be,” “will,” “expects,” “anticipates” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Forward-looking
statements include statements regarding our intentions, beliefs,
projections, outlook, analyses or current expectations concerning,
among other things: our expectation to share initial data from the
lanraplenib/gilteritinib trial, along with the RP2D, in the fourth
quarter of 2023 or first quarter of 2024; our belief that
lanraplenib has the potential to one day be the cornerstone of
targeted therapy-based regimens for the treatment of genetically
defined AML; our belief that our use of MRD in the development of
novel treatments for patients with AML will help to advance the
field and our own AML pipeline; 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 of novel therapeutics; MRD has only recently emerged as
a surrogate endpoint for progression free survival in hematological
malignancies, and while regulatory approvals on the basis of MRD
status have been granted in acute lymphocytic leukemia and chronic
lymphocytic leukemia, to date there have not been any regulatory
approvals on the basis of MRD status in AML; risks related to our
lack of experience as a company in conducting clinical trials; and
risks associated with the sufficiency of our cash resources and
need for additional capital. These and other risks and
uncertainties are described in greater detail in the company’s
filings with the Securities and Exchange Commission (“SEC”),
including under the heading “Risk Factors” in our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2022, filed with
the SEC on November 8, 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, the company
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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