Kymera Therapeutics Receives FDA Orphan Drug Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Peripheral T-Cell Lymphoma
June 01 2022 - 8:42AM
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing targeted protein degradation to
deliver novel small molecule protein degrader medicines, today
announced that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation to KT-333 for the treatment of
Peripheral T-cell Lymphoma (PTCL). KT-333 is a first-in-class
degrader of the transcriptional regulator STAT3. STAT3 activation
has been shown to be a key modulator of disease in PTCL, and there
are currently no approved therapies for PTCL that target this
pathway.
“The Orphan Drug Designation highlights the potential of this
first-in-class heterobifunctional degrader to transform the
treatment of PTCL by targeting STAT3, a protein that has
historically been undruggable,” said Nello Mainolfi, PhD,
Co-Founder, President and CEO, Kymera Therapeutics. “We look
forward to working with the lymphoma community to rapidly advance
KT-333 as a potential treatment for PTCL while we continue to
expand clinical investigation of this novel mechanism in other
cancers both in the hematological and in the solid tumor
space.”
The FDA's Orphan Drug Designation program provides
orphan status to drugs defined as those intended for the treatment,
diagnosis or prevention of rare diseases that affect fewer than
200,000 people in the United States. Orphan drug designation
qualifies the sponsor of the drug for certain development
incentives, including tax credits for qualified clinical testing,
prescription drug user fee exemptions and seven-year marketing
exclusivity upon FDA approval.
KT-333 is currently being evaluated in an ongoing Phase 1 trial
in adult patients with relapsed/refractory liquid and solid tumors,
including aggressive lymphomas. KT-333 is a potent and selective
heterobifunctional small molecule protein degrader which can
mediate degradation of the STAT3 protein. Normally, the STAT3
protein is activated by cytokines and growth factors, resulting in
transcriptional regulation of many important cellular functions. In
diseases including cancer, STAT3 activity becomes dysregulated,
resulting in persistent activation of STAT3.
About Peripheral T-cell
LymphomaPTCL, a subtype of non-Hodgkin’s lymphoma, is a
heterogenous group of tumors that arise from mature white blood
cells (T-cells) in the lymphoid tissues in areas such as the lymph
nodes, lungs, gastrointestinal tract and skin. Approximately 13,000
PTCL patients are diagnosed in the U.S. each year, and PTCL
accounts for 15% to 20% of aggressive lymphomas in the United
States. PTCLs carry a poorer prognosis than other
non-Hodgkin’s lymphomas since they are less responsive to standard
chemotherapy regimens.
About Kymera TherapeuticsKymera 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 STAT3 degrader
program; 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.
Investor Contact:Bruce Jacobs Chief Financial
Officer investors@kymeratx.com857-285-5300
Chris BrinzeyManaging Director,
Westwickechris.brinzey@westwicke.com339-970-2843
Media Contact:Todd CooperSenior Vice President,
Corporate Affairsmedia@kymeratx.com 857-285-5300
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