Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing a new class of small molecule
medicines using targeted protein degradation, today announced that
new KT-333 Phase 1 data highlighting safety, pharmacokinetics (PK),
pharmacodynamics (PD) and clinical responses will be presented at
the ASH 65th Annual Meeting and Exposition, taking place from
December 9-12, 2023, in San Diego, California. Results released in
an ASH abstract today include data as of a July 10, 2023 cut-off.
The poster presentation is expected to include additional data,
including PK/PD, safety and results of disease response assessments
from additional patients subsequent to the abstract cut-off date.
In addition, preclinical data will be presented supporting the
potential of STAT3 protein degraders as a therapeutic approach in
venetoclax-resistant Acute Myeloid Leukemia.
Highlights of the KT-333
Clinical Abstract
The abstract reported Phase 1 data from 21 patients enrolled
through dose level (DL) 5; 12 were evaluable for disease
assessment, including 1 with cutaneous T-cell lymphoma (CTCL) and 1
with peripheral T-cell lymphoma (PTCL) at DL2, and 10 with solid
tumors at DL1-4. Highlights include:
- One partial response reported after
two cycles in a CTCL patient at DL2, and stable disease reported
after two cycles in three solid tumor patients treated at DL3 and
DL4.
- PD data in blood available for DL1-4
demonstrated robust, dose-dependent, and sustained STAT3
degradation in peripheral blood mononuclear cells that,
particularly at DL3 and beyond, were at levels associated with
anti-tumor activity in preclinical models.
- No dose limiting toxicities or
serious adverse events were reported; the most common adverse
events were Grade 1/2 constipation, fatigue, nausea, and
anemia.
These data provide evidence of STAT3 targeted protein
degradation in humans with associated STAT3 pathway inhibition,
along with early signs of antitumor activity, highlighting the
potential of heterobifunctional degraders for targeting previously
undruggable transcription factors.
Poster Presentations at ASH
Title: Preliminary Safety, Pharmacokinetics, Pharmacodynamics
and Clinical Activity of KT-333, a Targeted Protein Degrader of
STAT3, in Patients with Relapsed or Refractory Lymphomas, Large
Granular Lymphocytic Leukemia, and Solid TumorsPresentation ID:
3081Session Date: Sunday, December 10, 2023 Presentation Time: 6:00
PM - 8:00 PM PTLocation: San Diego Convention Center, Halls
G-HPresenter: Dr. Aditi Shastri, Montefiore Medical Center and
Albert Einstein College of Medicine
Title: A STAT3 Degrader Demonstrates Pre-Clinical Efficacy in
Venetoclax Resistant Acute Myeloid LeukemiaPresentation ID:
2787Session Date: Sunday, December 10, 2023 Presentation Time: 6:00
PM - 8:00 PM PTLocation: San Diego Convention Center, Halls
G-HPresenter: Dr. Samarpana Chakraborty, Albert Einstein College of
Medicine
About KT-333 STAT3 Program KT-333 is designed
as a potent degrader of STAT3, a transcriptional regulator that has
been linked to numerous cancers as well as to inflammatory and
autoimmune diseases. KT-333 is being developed for the treatment of
STAT3-dependent hematological malignancies and solid tumors. The
Phase 1 clinical trial of KT-333 is designed to evaluate the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD)
and clinical activity of KT-333 dosed weekly in adult patients with
relapsed and/or refractory lymphomas, leukemias and solid tumors.
The U.S. Food and Drug Administration (FDA) has granted KT-333
orphan drug designation for the treatment of Cutaneous T-cell
Lymphoma (CTCL) and Peripheral T-cell Lymphoma (PTCL) and fast
track designation for the treatment of relapsed/refractory CTCL and
PTCL.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05225584.
About Kymera Therapeutics Kymera is a
biopharmaceutical company pioneering the field of targeted protein
degradation, a transformative approach to address disease targets
and pathways inaccessible with conventional therapeutics. Kymera’s
Pegasus platform is a powerful drug discovery engine, advancing
novel small molecule programs designed to harness the body’s innate
protein recycling machinery to degrade dysregulated,
disease-causing proteins. With a focus on undrugged nodes in
validated pathways, Kymera is advancing a pipeline of novel
therapeutic candidates designed to address the most promising
targets and provide patients with more effective treatments.
Kymera’s initial programs target IRAK4, and STAT3 within the
IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing
the opportunity to treat patients with a broad range of
immune-inflammatory diseases, hematologic malignancies, and solid
tumors.
Founded in 2016, Kymera is headquartered in Watertown, Mass.
Kymera has been named a “Fierce 15” company by Fierce Biotech and
has been recognized by both the Boston Globe and the Boston
Business Journal as one of Boston’s top workplaces. For more
information about our people, science and pipeline, please visit
www.kymeratx.com or follow us on X (previously Twitter) or
LinkedIn. Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
implied and express statements by Kymera Therapeutics regarding
its: strategy, business plans and objectives for our clinical stage
degrader programs; plans and timelines for the preclinical and
clinical development of its product candidates, including the
therapeutic potential, clinical benefits and safety thereof;
expectations regarding timing, success and data announcements of
current ongoing preclinical and clinical trials; the ability to
initiate new clinical programs; and Kymera’s financial condition
and expected cash runway into the first half of 2026. The words
"may," “might,” "will," "could," "would," "should," "expect,"
"plan," "anticipate," "intend," "believe," “expect,” "estimate,"
“seek,” "predict," “future,” "project," "potential," "continue,"
"target" and similar words or expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements in this press release are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release,
including, without limitation, risks associated with: the timing
and anticipated results of our current and future preclinical
studies and clinical trials, supply chain, strategy and future
operations; the delay of any current and future preclinical studies
or clinical trials or the development of Kymera Therapeutics' drug
candidates, including those for KT-474, KT-333, KT-413 and KT-253;
the risk that the results of current preclinical studies and
clinical trials may not be predictive of future results in
connection with current or future preclinical and clinical trials;
Kymera Therapeutics' ability to successfully demonstrate the safety
and efficacy of its drug candidates; the timing and outcome of the
Kymera Therapeutics' planned interactions with regulatory
authorities; obtaining, maintaining and protecting its intellectual
property; the risks associated with pandemics or epidemics; and
Kymera Therapeutics' relationships with its existing and future
collaboration partners. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in the Annual Report on Form 10-K for the period ended December 31,
2022, and most recent Quarterly Report on Form 10-Q, as well as
discussions of potential risks, uncertainties, and other important
factors in Kymera Therapeutics' subsequent filings with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent Kymera Therapeutics' views
only as of today and should not be relied upon as representing its
views as of any subsequent date. Kymera Therapeutics explicitly
disclaims any obligation to update any forward-looking statements.
No representations or warranties (expressed or implied) are made
about the accuracy of any such forward-looking statements.
Investor
Contact:Justine KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.com857-285-5300 |
Media
Contact:Todd CooperSenior Vice President, Corporate
Affairsmedia@kymeratx.com857-285-5300 |
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