KT-333 is a first-in-class heterobifunctional
degrader of the transcriptional regulator STAT3 in development for
T cell malignancies and solid tumors
KT-413 is a first-in-class degrader of IRAK4
and the IMiD substrates Ikaros and Aiolos in development for
MYD88-mutant B cell lymphomas
Initial safety and proof-of-mechanism clinical
data for both programs to be shared in second half of 2022
WATERTOWN, Mass., June 15,
2022 /PRNewswire/ -- Kymera Therapeutics, Inc.
(NASDAQ: KYMR), a clinical-stage biopharmaceutical company
advancing targeted protein degradation to deliver novel small
molecule protein degrader medicines, has recently dosed the first
patients in separate Phase 1 clinical trials evaluating the STAT3
degrader KT-333 and the IRAKIMiD degrader KT-413. The KT-333 trial
includes patients with relapsed/refractory liquid and solid tumors,
including T cell lymphomas and leukemia, and the KT-413 study is
enrolling patients with relapsed/refractory B cell lymphomas,
including MYD88-mutant diffuse large B cell lymphoma (DLBCL).
![(PRNewsfoto/Kymera Therapeutics LLC) (PRNewsfoto/Kymera Therapeutics LLC)](https://mma.prnewswire.com/media/592583/Kymera_Logo.jpg)
"These programs demonstrate the potential for targeted protein
degradation to target critical nodes that traditional modalities
can't effectively address, offering a precision medicine approach
to challenging cancers," said Nello
Mainolfi, PhD, Co-Founder, President and CEO of Kymera
Therapeutics. "The initiation of dosing in these studies represents
important progress for Kymera toward understanding the pharmacology
and safety of these first-in-class investigational medicines, and
we look forward to sharing initial dose escalation clinical data
later this year."
About the KT-333 Clinical Program
A target long considered "undruggable," STAT3 is a
transcriptional regulator that has been linked to numerous cancers
and other inflammatory and autoimmune diseases. KT-333 is a potent
and selective heterobifunctional small molecule protein degrader of
the STAT3 protein in development for oncology indications.
The Phase 1 trial will evaluate the safety, tolerability, PK/PD
and clinical activity of KT-333 in adult patients with relapsed
and/or refractory lymphomas and solid tumors. The first stage of
the study will explore escalating doses of KT-333. The second stage
will consist of four expansion cohorts to further characterize the
safety, tolerability, PK/PD and antitumor activity of KT-333 in
relapsed and/or refractory peripheral T-cell lymphoma (PTCL),
cutaneous T-cell lymphoma (CTCL), large granular lymphocytic
leukemia (LGL-L), and solid tumors.
KT-333 was recently granted Orphan Drug Designation by the U.S.
Food and Drug Administration for the treatment of PTCL. This
designation provides incentives to encourage the development of
medicines for rare diseases.
About the KT-413 Clinical Program
KT-413 is a potent and selective heterobifunctional small
molecule protein degrader being developed for MYD88-mutant B cell
lymphomas that has the potential to be the first precision medicine
for these cancers. KT-413 degrades interleukin-1 receptor
associated kinase 4 (IRAK4) and the immunomodulatory imide drug
(IMiD) substrates Ikaros and Aiolos. It is being developed
initially for the treatment of relapsed/refractory MYD88-mutant
DLBCL, with the potential to expand into other MYD88-mutant
indications.
The Phase 1 trial will evaluate the safety, tolerability, and
PK/PD of KT-413 in patients with relapsed and/or refractory B-cell
non-Hodgkin's lymphomas. The first stage will explore escalating
doses of single-agent KT-413. The second stage will consist of two
expansion cohorts to further characterize the safety, tolerability,
PK/PD and antitumor activity of KT-413 in relapsed/refractory
MYD88-mutant and MYD88 wild-type DLBCL.
About Kymera Therapeutics
Kymera Therapeutics (Nasdaq: KYMR) 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 therapies that 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 therapeutics designed to address the most
intractable pathways and provide new treatments for patients.
Kymera's initial programs target IRAK4, IRAKIMiD, and STAT3 within
the IL-1R/TLR or JAK/STAT pathways, providing the opportunity to
treat patients with a broad range of immune-inflammatory diseases,
hematologic malignancies, and solid tumors. For more information,
visit www.kymeratx.com.
Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a
"Fierce 15" biotechnology company by Fierce Biotech and has been
recognized by the Boston Business Journal as one of Boston's "Best Places to Work." 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 regarding its: strategy, business
plans and objectives for the IRAKIMiD and STAT3 degrader programs;
and plans and timelines for the clinical development of Kymera
Therapeutics' product candidates, including the therapeutic
potential and clinical benefits thereof. 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
preclinical studies and future clinical trials, strategy and future
operations; the delay of any current preclinical studies or future
clinical trials or the development of Kymera
Therapeutics' drug candidates; the risk that the results
of current preclinical studies may not be predictive of future
results in connection with future clinical trials; Kymera
Therapeutics' ability to successfully demonstrate the safety and
efficacy of its drug candidates; the timing and outcome of the
Company's planned interactions with regulatory authorities; and
obtaining, maintaining and protecting its intellectual
property. 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 period ended
March 31, 2022, filed on May 3, 2022, 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.
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