Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation
(TPD) to deliver novel small molecule protein degrader medicines,
today announced new data demonstrating that its oncology programs
KT-333 and KT-413 continue to demonstrate substantial target
knockdown in ongoing Phase 1a dose escalation clinical trials,
with no dose limiting toxicities (DLTs) observed. The data were
shared in the online abstract book of the International Conference
on Malignant Lymphoma (ICML), taking place from June 13-17, 2023,
in Lugano, Switzerland, and reflect a data cut-off date of February
3, 2023. On June 14, a KT-333 poster will be released at ICML and
presented on June 16. Kymera will share updated results from both
programs in conjunction with the poster release on June 14.
Highlights of the KT-333 Abstract
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.
As of the abstract cut-off date of February 3, 2023, 7 patients
had been treated in the first 2 dose levels (DL1 and DL2) of the
trial, including patients with solid tumors as well as peripheral
T-cell lymphoma and cutaneous T-cell lymphoma:
- Plasma PK results were in line with the modeled
predictions.
- PD data in peripheral blood mononuclear cells (PBMC)
demonstrated dose-dependent and sustained STAT3 degradation after
dosing on Days 1 and 8, with mean maximum decrease of 66% in DL1
and 70% in DL2.
- The most common adverse events were Grade 1 and 2 and included
constipation, fatigue, abdominal pain, dizziness, and nausea. No
DLTs were observed and no patients discontinued KT-333 due to an
adverse event.
- Accrual into the study is ongoing, and analyses from additional
patients will be presented at ICML.
As previously announced, Kymera intends to present data
evaluating anti-tumor activity in the target patient population
later this year.
KT-333 Presentation at ICML
Title: Phase 1 Trial of KT-333, a STAT3 Degrader, in Patients
with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic
Leukemia and Solid TumorsPresentation ID: 424Session Time: 12:30
p.m. - 1:00 p.m. CEST, June 16, 2023 Location: Marquee Parco
CianiPresenter: Dr. Adam Olszewski, Lifespan Cancer Institute,
Rhode Island Hospital
Highlights of the KT-413 Abstract
KT-413 is a novel heterobifunctional degrader targeting both
IRAK4 and the IMiD substrates Ikaros and Aiolos. Designed to
address both the IL-1R/TLR and Type 1 IFN pathways synergistically
with a single molecule, KT-413 is in development for the treatment
of MYD88-mutant B-cell malignancies. The Phase 1 clinical trial of
KT-413 is designed to evaluate the safety, tolerability, PK/PD and
clinical activity of KT-413 administered as an intravenous infusion
once every 3 weeks to adult patients with relapsed and/or
refractory B-cell non-Hodgkin's lymphomas.
As of the abstract cut-off date of February 3, 2023, 3 patients
had been treated in the first 3 dose levels of the trial, including
transformed activated B-cell-like (ABC)-diffuse large B-cell
lymphoma (DLBCL), follicular lymphoma and marginal zone lymphoma,
all of which were MYD88 wild-type:
- Plasma PK results were in line with the modeled
predictions.
- Dose-dependent, sustained target knockdown in PBMC was
observed, with up to 57% reduction in IRAK4 and 96-100% reduction
in Ikaros and Aiolos by DL3. Degradation was also demonstrated in
serial tumor biopsies obtained in DL1.
- The most common adverse events across all three dose levels
were Grade 1 and 2 fatigue and pyrexia. No DLTs were
observed.
- Accrual into the study is ongoing, and analyses from additional
patients will be shared in an update from Kymera in conjunction
with the KT-333 ICML update.
As previously announced, Kymera intends to present data
evaluating anti-tumor activity in the target patient population
later this year.
About Kymera TherapeuticsKymera 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, IRAKIMiD, 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 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 the IRAKIMiD and
STAT3 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 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 impact of
COVID-19 on countries or regions in which we have operations or do
business, as well as on 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; 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, including those for KT-474,
KT-333, KT-413 and KT-253; 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; 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2023 filed on May 4, 2023, 2023, 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: Bruce Jacobs Chief Financial
Officer investors@kymeratx.com 857-285-5300 Chris
Brinzey Managing Director,
Westwicke chris.brinzey@westwicke.com 339-970-2843 |
Media
Contact: Todd Cooper Senior Vice
President, Corporate
Affairs media@kymeratx.com 857-285-5300 |
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