Companion diagnostic would be used following potential
regulatory approval of entospletinib to screen for NPM1 mutation
present in approximately one-third of all patients with
AML
Entospletinib is currently being studied in the Phase 3
AGILITY registrational study, with data anticipated in second half
of 2023
SAN
MATEO, Calif. and SAN
DIEGO, Aug. 16, 2022 /PRNewswire/ -- Kronos Bio,
Inc. (Nasdaq: KRON), a company dedicated to transforming the lives
of those affected by cancer, and Invivoscribe, a global provider of
diagnostic kits and services for oncology, today announced their
agreement to develop a companion diagnostic (CDx) for use with
Kronos Bio's investigational therapy, entospletinib. Entospletinib
is Kronos Bio's lead clinical compound, currently in the ongoing
Phase 3 registrational AGILITY study for the treatment of newly
diagnosed NPM1-mutated acute myeloid leukemia (AML).
The diagnostic will screen for the NPM1 mutation, which is
present in approximately one-third of all patients with AML.
Over the past year, the two companies have worked together to
develop and advance the diagnostic and prepare to submit the
Premarket Approval (PMA) application to the U.S. Food and Drug
Administration (FDA) at the same time as the submission of the
entospletinib New Drug Application (NDA). The FDA requires the
validation and approval of companion diagnostics used to select
patients for treatment with a specific therapeutic agent.
The agreement builds on Invivoscribe's experience in developing
and obtaining approval for diagnostics used for identification of
patients with genetically mutated AML. Invivoscribe markets an
FDA-approved CDx for FLT3-mutated AML.
"This companion diagnostic NPM1 mutation
assay development work with Kronos Bio represents a significant
milestone for our company," said Jeffrey
Miller, Ph.D., chief scientific officer and chief executive
officer of Invivoscribe. "Companion diagnostics play a key role in
the development and approval of targeted drug therapies and these
kinds of partnerships are critical to improving care for patients
with cancer."
Kronos Bio's AGILITY trial is designed to assess the
efficacy and safety of entospletinib in approximately 180 adults
who have been newly diagnosed with NPM1-mutated AML. In the trial,
patients are being randomized to receive entospletinib or placebo,
in combination with standard induction and consolidation
chemotherapy. The primary endpoint of the trial is measurable
residual disease (MRD) negative complete response. Event-free
survival (EFS) is a key secondary endpoint, and mature EFS data are
anticipated to be used to support potential full
approval.
"The development of the NPM1 mutation companion diagnostic
is a critical step in our efforts to rapidly advance
entospletinib," said Jorge
DiMartino, M.D., Ph.D., chief medical officer and executive
vice president of Clinical Development at Kronos Bio. "We are
fortunate to benefit from Invivoscribe's prior experience in
bringing to market companion diagnostics for patients with
AML."
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.
About Invivoscribe
Invivoscribe has focused on Improving Lives with Precision
Diagnostics® for more than 28
years, advancing the field of precision medicine by developing and
selling standardized reagents, tests, and bioinformatics tools to
more than 700 customers in 160 countries. Invivoscribe also has a
significant impact on global health working with pharmaceutical
companies to accelerate approvals of new drugs and treatments by
supporting international clinical trials, developing,
commercializing companion diagnostics, and providing expertise in
both regulatory and laboratory services. With its proven ability to
provide global access to distributable reagents, kits, and
controls, as well as clinical trial services through our
international clinical lab subsidiaries (LabPMM),
Invivoscribe has demonstrated it is an ideal partner. For
additional information please visit:
www.invivoscribe.com or contact Invivoscribe at:
customerservice@invivoscribe.com.
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," "designed," "following," "potential,"
"prepare," "will," "would" 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 potential successful development of a companion
diagnostic for use with entospletinib; the potential submission of
a PMA for such companion diagnostic; the potential
validation and regulatory approval of the companion diagnostic and
its use with entospletinib following approval; the potential
regulatory approval of entospletinib; the anticipated
use of mature EFS data to support potential full
approval of entospletinib; the anticipated timing for
data from the AGILITY trial; the design of the AGILITY
trial; 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 and Invivoscribe
will be able to successfully develop a companion diagnostic for use
with entospletinib on the timeline expected, or at all, including
risks related to contractual performance and Kronos Bio's reliance
on Invivoscribe to complete the validation of the companion
diagnostic necessary to meet regulatory requirements; whether
Kronos Bio will be able to initiate, progress or complete the
AGILITY trial on the timeline expected, or 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; risks related to regulatory approval of novel
therapeutic products and companion diagnostics, including the risk
that lack of approval of a companion diagnostic (including the
companion diagnostic being developed for use with entospletinib)
may jeopardize approval of the novel therapeutic product (including
entospletinib); 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.
Kronos Bio Contacts:
Marni
Kottle
Kronos Bio
(650) 900-3450
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
Invivoscribe Contact:
Tony
Lialin
Chief Commercial Officer, Invivoscribe
tlialin@invivoscribe.com
Logo -
https://mma.prnewswire.com/media/1877742/Invivoscribe_Technologies_Inc_Kronos_Bio_Partnership.jpg