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 Fast Track designation to KT-333 for the treatment of R/R
Cutaneous T-cell Lymphoma (CTCL) and R/R Peripheral T-cell Lymphoma
(PTCL).
KT-333 is a highly selective degrader of STAT3 in development
for the treatment of multiple STAT3-dependent pathologies,
including hematological malignancies and solid tumors. STAT3 is a
transcriptional regulator that has been linked to numerous cancers
as well as to inflammatory and autoimmune diseases. In 2022, KT-333
received FDA orphan drug designation for the treatment of both CTCL
and PTCL.
“The KT-333 Fast Track designation highlights the promise of
degrading STAT3, a protein that has historically been undruggable,
for the treatment of patients with CTCL and PTCL,” said Jared
Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “We look
forward to providing an update on the KT-333 Phase 1 clinical trial
later this year, including initial evaluation of its antitumor
activity in the target patient populations, and to working with the
lymphoma community to rapidly advance this first-in-class
heterobifunctional degrader in CTCL and PTCL in addition to
exploring its potential in other cancers.”
The FDA’s Fast Track process is designed to get important new
medicines to patients more quickly, facilitating the development
and expediting the review of therapies intended to treat serious
conditions and address unmet medical needs. Companies whose
programs are granted Fast Track designation are eligible for more
frequent interactions with the FDA during clinical development and
potentially accelerated approval and/or priority review, if
relevant criteria are met. For more information on the Fast Track
process, please visit the FDA’s official website.
About the KT-333 Clinical ProgramThe Phase 1
clinical trial of KT-333 is designed to evaluate the safety,
tolerability, PK/PD and clinical activity of KT-333 dosed weekly in
adult patients with relapsed and/or refractory lymphomas, leukemias
and solid tumors. In June at the International Conference on
Malignant Lymphoma (ICML), with a data cutoff date of May 1, 2023,
Kymera presented data on thirteen patients who received a mean of
five doses across the first four dose levels (DL1-4) of the trial,
including patients with solid tumors, CTCL and PTCL. With DL4 still
open to accrual at the time of the presentation, data reported from
DL1-3 found plasma exposure increased with dose, reaching levels
close to those predicted to be efficacious, and demonstrated
dose-dependent STAT3 degradation with up to 88% mean maximum
reduction in peripheral blood mononuclear cells and degradation
profiles at DL3 near levels of knockdown that led to antitumor
activity in preclinical models. We shared at ICML that there were
no dose-limiting toxicities observed in the study. The Phase 1a
dose escalation stage is ongoing, recruiting broadly across solid
and liquid tumors, and more information can be found at
www.clinicaltrials.gov, identifier NCT05225584.
About Cutaneous T-Cell LymphomaCutaneous
T-cell lymphoma (CTCL) is a general term for non-Hodgkin’s T-cell
lymphomas that are primarily characterized by an abnormal
accumulation of T-cells in the skin and can involve the blood,
lymph nodes and other internal organs. Approximately 3,000 CTCL
patients are diagnosed in the U.S. each year, and CTCL accounts for
25% of T-cell lymphomas in the U.S. CTCL is a typically
slow-growing cancer, with symptoms such as dry skin, potentially
severe itching, rashes and enlarged lymph nodes. Since symptoms and
skin biopsy findings are similar to other skin conditions,
early-stage diagnosis can be difficult.
About Peripheral T-cell LymphomaPTCL, a subtype
of non-Hodgkin’s lymphoma, is a heterogenous group of tumors that
arise from mature T-cells in the lymphoid tissues in areas such as
the lymph nodes, lungs, gastrointestinal tract and skin.
Approximately 4,000-8,000 PTCL patients are diagnosed in the U.S.
each year, and PTCL accounts for 15% to 20% of aggressive lymphomas
in the U.S. PTCL carries a poorer prognosis than other
non-Hodgkin’s lymphomas since it is less responsive to standard
chemotherapy regimens.
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 IRAK4,
IRAKIMiD, STAT3, and MDM2 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 ability to initiate new clinical programs; and Kymera’s
financial condition and expected cash runway into the second half
of 2025. 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 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 (SAR444656), 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; the risks associated with pandemics or
epidemics; 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 Annual Report on Form 10-K for the
period ended December 31, 2022 and most recent Quarterly Report on
Form 10-Q, 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: Justine KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.com857-285-5300 |
Media
Contact: Todd Cooper Senior Vice President,
Corporate
Affairs media@kymeratx.com 857-285-5300 |
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