Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation
(TPD) to deliver novel small molecule protein degrader medicines,
today shared new data demonstrating that its oncology programs
KT-333 and KT-413 continue to demonstrate robust dose-dependent
target knockdown in ongoing Phase 1a dose escalation clinical
trials, with no dose limiting toxicities (DLTs) observed. The
KT-333 clinical data will be presented in a poster at the
International Conference on Malignant Lymphoma (ICML) on June 16,
2023, in Lugano, Switzerland.
“Our focus this year for our ongoing KT-333 and KT-413 clinical
trials will be to analyze the degradation profiles and safety of
these first-in-class mechanisms and evaluate their biological and
clinical impact in the appropriate patient populations. We continue
to see encouraging data from the trials’ dose escalation phases as
they show fidelity of PK/PD translation from preclinical models to
patients, demonstrating target degradation without any dose
limiting toxicities observed, and approaching levels we believe are
needed to achieve antitumor activity,” said Nello Mainolfi,
Founder, President and CEO, Kymera Therapeutics. “We are proud and
excited to be the first company to have shown clinical translation
of our degraders’ profiles across three programs and across
multiple diseases and indications. We look forward to sharing
additional data evaluating antitumor activity in the target patient
populations for these programs later this year.”
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, PK/PD and
clinical activity of KT-333 dosed weekly on 28-day cycles in adult
patients with relapsed and/or refractory lymphomas, leukemias and
solid tumors.
As of the data cut-off of May 1, 2023, thirteen patients
received a mean of five doses across the first four dose levels
(DL1-4) of the trial, including patients with solid tumors as well
as peripheral and cutaneous T-cell lymphoma. This includes 2
patients enrolled in DL4, which remains open to accrual. As of the
cut-off date, there were no AEs reported in DL4. Data reported from
the 3 completed dose levels (DL1-3) found:
- Plasma exposure increased with dose, reaching levels close to
those predicted to be efficacious.
- KT-333 demonstrated dose-dependent STAT3 degradation with up to
88% mean maximum reduction in peripheral blood mononuclear cells
(PBMCs), with evidence of STAT3 pathway inhibition and
downregulation of inflammatory biomarkers in peripheral blood.
Degradation profiles at DL-3 were near levels of knockdown that led
to profound antitumor activity in preclinical models.
- No DLTs were observed in the study.
KT-333 Poster 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
KT-413 IRAKIMiD Program
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 IV infusion once
every 3 weeks to adult patients with relapsed and/or refractory
B-cell non-Hodgkin's lymphomas.
As of the data cut-off of June 1, 2023, DL1-3 have been
completed and DL4 remains open to accrual. Five patients were
treated across DL1-4 and received a mean of 2.2 doses. These
included patients with transformed activated B-cell-like
(ABC)-diffuse large B-cell lymphoma (DLBCL), follicular lymphoma,
marginal zone lymphoma, and plasmablastic lymphoma, all of whom
were MYD88 wild-type except for one who had a MYD88
gain-of-function mutation. Data reported across the 4 DLs through
the cut-off date show:
- Plasma exposure increased with dose, reaching levels close to
those predicted to be efficacious.
- KT-413 achieved dose-dependent degradation of up to 70% IRAK4
and 96-100% Ikaros and Aiolos in PBMC after a single dose.
Degradation profiles at DL3-4 were consistent with knockdown levels
associated with profound antitumor activity in preclinical models
of MYD88 mutant lymphomas.
- No DLTs or drug-related neutropenia were observed in the
study.
Updated data with more details for both programs can be found in
the Kymera corporate presentation on the Company’s website, as well
as the KT-333 ICML poster presentation.
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
Statements
This 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, 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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