Kronos Bio Presents Positive Preliminary Data from the Phase 1 Dose Escalation Portion of the Ongoing Phase 1/2 KB-0742 Study at the Connective Tissue Oncology Society Annual Meeting
03 11월 2023 - 1:00AM
Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to
transforming the lives of those affected by cancer, today announced
the presentation of positive preliminary data from the phase 1 dose
escalation portion of the ongoing phase 1/2 KB-0742 study at the
Connective Tissue Oncology Society annual meeting in Dublin,
Ireland. Today’s presentation by Dr. Van Tine of Washington
University School of Medicine includes clinical data that was first
presented at the AACR-NCI-EORTC International Conference on October
13, 2023, in Boston, Massachusetts in the context of pre-clinical
models that provide a better understanding of the observed
anti-tumor activity. Preclinical studies led by Berkley Gryder,
PhD, of Case Western Reserve University demonstrated KB-0742's
on-mechanism activity in transcription factor fusion positive
models for rhabdomyosarcoma and Ewing sarcoma.
“Sarcomas are very complex to diagnose and treat so there is a
significant need for innovation in this field,” said Brian Van
Tine, M.D., of Washington University School of Medicine in St.
Louis. “I am very encouraged by the positive preliminary KB-0742
data, not only for what it could mean for sarcoma patients, but
also for other cancer types given evidence of on-mechanism clinical
activity and a manageable safety profile. Today, I shared a case
study on one of my sarcoma patients who exhausted all standard
therapies as well as multiple experimental treatments. This patient
received KB-0742 for more than a year and experienced objective
clinical benefit, including the shrinkage of their tumor. I look
forward to learning more about the utility of KB-0742 from the
ongoing dose escalation and expansion studies.”
“We now have positive preliminary KB-0742 clinical efficacy and
safety data that corresponds with what we saw in the read-outs from
the pre-clinical mechanistic studies,” said Jorge DiMartino M.D.,
Ph.D.Chief Medical Officer and Executive Vice President, Clinical
Development. “Data show that KB-0742 reduces expression of
oncogenic TF fusions and this translates into anti-tumor activity.
This further bolsters our confidence that the drug is behaving the
way we expected.”
KB-0742 is Kronos Bio’s internally discovered, highly selective,
orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor
being developed to treat transcriptionally addicted solid tumors,
including small cell lung cancer, sarcomas with transcription
factor fusion genes and MYC-dependent tumors, such as triple
negative breast, ovarian, and lung cancer. The preliminary analysis
included 28 patients enrolled in a dose escalation study who
received doses from 10 mg up to 60 mg (data cut-off September 1st,
2023). KB-0742 demonstrated on-mechanism single agent anti-tumor
activity in heavily pre-treated patients with transcriptionally
addicted tumor types and exhibited a manageable safety profile,
with no grade 3/4 neutropenia. KB-0742 also demonstrated dose
proportional exposure, dose-dependent target engagement, and
24-hour plasma half-life.
The most prevalent treatment-emergent adverse events (TEAEs)
included nausea (64%), vomiting (68%) and fatigue (29%), all of
which were grade 1/2. No grade 3/4 neutropenia was observed, and no
treatment-related deaths were observed. The most common reasons for
treatment discontinuation were progressive disease, TEAEs, and
withdrawal of consent.
To learn more about the preliminary positive KB-0742 data
presented at the AACR-NCI-EORTC International Conference on October
13, 2023, in Boston, Mass. you may
visithttps://ir.kronosbio.com/news-releases/news-release-details/kronos-bio-presents-positive-preliminary-data-phase-1-dose
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 other
transcriptionally addicted solid tumors and lanraplenib, a
next-generation SYK inhibitor, for patients with FLT3-mutated acute
myeloid leukemia. The company’s scientific focus is on developing
medicines that target the deregulated 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 “on track to,” “plan,” “potential,” “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, Kronos Bio’s the expected timing
for data from the dose expansion portion of the study, the promise
of KB-0742 to treat patients with transcriptionally addicted
tumors, KB-0742 being a promising agent to treat a wide variety of
cancers with high unmet need, future results that may be implied
from preliminary data, 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 its clinical trials on the timelines anticipated,
including due to 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; and the risk
that results of preclinical studies and early clinical trials
(including preliminary results) are not necessarily predictive of
future results. 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, 2023,
filed with the SEC on August 8, 2023. 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:Sarah Connors, Vice President
of Investor Relations and Corporate CommunicationsKronos
Bio857-290-7305sconnors@kronosbio.com
Agency Contact:Brendan Strong, Managing
DirectorArgot Partners
212-600-1902kronosbio@argotpartners.com
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