Kymera Therapeutics Doses First Patient in Phase 1 Oncology Trial of MDM2 Degrader KT-253
19 Maio 2023 - 8:00AM
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation
(TPD) to deliver novel small molecule protein degrader medicines,
has recently dosed the first patient in the Phase 1 multicenter,
open-label, dose-escalation clinical trial evaluating its
investigational MDM2 degrader KT-253. The Phase 1 study will
evaluate the safety, tolerability,
pharmacokinetics/pharmacodynamics, and clinical activity of
ascending doses of KT-253 in adult patients with relapsed or
refractory high grade myeloid malignancies, acute lymphocytic
leukemia (ALL), lymphomas, and solid tumors.
KT-253 targets MDM2, the crucial regulator of the most common
tumor suppressor, p53. p53 remains intact (wild type) in close to
50% of cancers, meaning that it retains its ability to modulate
cancer cell growth. While small molecule inhibitors have been
developed to stabilize and upregulate p53 expression, they have
been found to induce a feedback loop that increases MDM2 protein
levels, which can repress p53 and limit their efficacy. In
preclinical studies, KT-253 has shown the ability to overcome the
MDM2 feedback loop and rapidly induce cancer cell death, even with
brief exposures. This may also improve KT-253’s therapeutic index,
potentially providing the opportunity for an improved efficacy and
safety profile.
“At Kymera, we are focused on applying targeted protein
degradation to well-validated targets that cannot be addressed, or
are inadequately addressed, with conventional medicines. We believe
that KT-253 has the potential to overcome the inherent limitations
of small molecule MDM2 inhibitors and provide a more effective
option for patients with a variety of cancers,” said Jared Gollob,
M.D., Chief Medical Officer of Kymera Therapeutics. “The initiation
of dosing in this study represents important progress toward
understanding the pharmacology and safety of this first-in-class
investigational medicine, and we look forward to sharing initial
dose escalation clinical data, focused on PK/PD and safety, later
this year.”
Patients in the KT-253 Phase 1 open-label, dose escalation study
will receive doses of KT-253 administered once every 3 weeks. The
study is intended to identify the recommended Phase 2 dose for
KT-253, and will be comprised of two arms, with ascending doses of
KT-253 in each arm. The first arm will consist of patients with
relapsed or refractory lymphomas and advanced solid tumors and the
second arm will consist of patients with relapsed or refractory
high grade myeloid malignancies and ALL.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05775406.
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 MDM2 degrader
program; plans and timelines for the preclinical and clinical
development of KT-253, including the therapeutic potential,
clinical benefits and safety thereof; expectations regarding timing
and, 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 or any
future pandemics 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 CooperSenior Vice President, Corporate
Affairsmedia@kymeratx.com857-285-5300 |
Kymera Therapeutics (NASDAQ:KYMR)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Kymera Therapeutics (NASDAQ:KYMR)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024