Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing a new class of small molecule
medicines using targeted protein degradation (TPD), today announced
that its preclinical data demonstrating the therapeutic potential
of its potent and selective heterobifunctional degraders of STAT6
(KT-621) and TYK2 (KT-294) are being presented in the poster
session at the American Academy of Dermatology’s Annual Meeting in
San Diego, California. Kymera’s oral STAT6 and TYK2 degraders have
the potential to address multiple immune-mediated diseases and
overcome the limitations of existing technologies and agents.
Today’s poster presentations mark the first time that data from a
STAT6 targeted agent and a TYK2 degrader have been shared at a
major medical meeting. Based on the results generated to date,
Kymera intends to initiate Phase 1 testing for KT-621 and KT-294 in
the in the second half of 2024 and the first half of 2025,
respectively. Data from both Phase 1 trials are expected to be
reported in 2025.
“Our differentiated strategy to targeted protein
degradation has resulted in an industry-leading immunology pipeline
of oral degrader medicines, each with the potential to treat
multiple complex immuno-inflammatory diseases. Our preclinical
findings demonstrate the potential advantage of using oral
degraders over other technologies to effectively drug critical
signaling nodes driving inflammation in a variety of diseases,”
said Nello Mainolfi, PhD, Founder, President and CEO, Kymera
Therapeutics. “Importantly, we believe our STAT6 and TYK2 degraders
provide the convenience of oral medicines with the potential for
biologics-like activity and in doing so reach broader patient
populations compared to injectable biologics or other standards of
care.”
The findings presented today demonstrate that in
preclinical studies, KT-621, Kymera’s first-in-class oral STAT6
degrader, was exquisitely selective for STAT6 over other STATs and
fully blocked IL-4/IL-13 functions in key human TH2 cellular assays
with picomolar potency that was superior to dupilumab. At low daily
oral doses, preclinical studies with KT-621 demonstrated near full
in vivo STAT6 degradation in disease-relevant tissues that was
well-tolerated. In a MC903-induced atopic dermatitis mouse model,
KT-621 demonstrated robust degradation of STAT6 in spleen and
marked reduction of total serum IgE comparable to the activity of
dupilumab. These data demonstrate the potential of KT-621 for the
treatment of atopic dermatitis and other allergic diseases with
best-in-pathway potential given its dupilumab-like activity profile
and the convivence of an oral pill.
Additionally, in preclinical studies, KT-294,
Kymera’s first-in-class highly selective oral TYK2 degrader,
demonstrated picomolar degradation potency and potent inhibition of
the IL-23, IL-12 and Type I IFN pathways, showing its potential to
recapitulate the biology of human TYK2 loss-of-function profile.
KT-294, does not impact any of the other Janus kinase (JAK)
proteins and in doing so spares IL-10, unlike the TYK2 small
molecule inhibitor, deucravacitinib, which is important in
inflammatory bowel disease. In addition, TYK2 degradation leads to
superior inhibition of the Type 1 IFN pathway compared to TAK-2791,
which is relevant to the treatment of interferonopathies. The
biological differentiation of the TYK2 degrader, KT-294, combined
with the ability to provide deep and sustained TYK2 knockdown in
vivo with low daily oral doses, has the potential to deliver a
best-in-class TYK2 profile with broad activity across multiple
IL-12/IL-23- and IFN-driven immune-inflammatory diseases
potentially reaching pathway biologics activity.
The company plans to share additional preclinical
data for KT-621 and KT-294 at upcoming medical meetings in
2024.
Copies of both poster presentations entitled
“Potent and Selective Oral STAT6 Degraders Inhibit IL-4 and IL-13
Functions in Human Cells and Block TH2 Inflammation in a Mouse
Model of Atopic Dermatitis” and “Potent and Selective TYK2
Degraders, Devoid of JAK Activity, Potently and Completely Suppress
IL-12/23 and Type I IFN Signaling Pathways” are available in the
Resource Library section of Kymera's website.
About STAT6 Degrader STAT6 is an
essential transcription factor in the IL-4/IL-13 signaling pathways
and the central driver of TH2 inflammation in allergic diseases.
Multiple gain of function mutations of STAT6 were identified to
cause severe allergic diseases in humans. Dupilumab, an injectable
monoclonal antibody that blocks IL-4/IL-13 signaling, is an
approved therapy for multiple allergic diseases. STAT6 targeting is
therefore supported by both human genetics and clinical pathway
validation. STAT6 functions through protein-protein and protein-DNA
interactions, and it has been challenging to selectively and
potently inhibit STAT6 with small molecule inhibitors. However, it
is well suited for a targeted protein degradation approach, where a
binding event is sufficient to drive degradation. KT-621 is a once
daily, oral STAT6 degrader with a potential biologics-like efficacy
profile, to address multiple diseases including atopic dermatitis,
asthma, and chronic obstructive pulmonary disorder, among
others.
About TYK2 Degrader TYK2 is a
member of the JAK family of kinases that binds the IL-12, IL-23 and
interferon (IFN) receptors to recruit and phosphorylate STAT
transcription factors. A loss of function variant is protective in
autoimmune diseases and an allosteric inhibitor of TYK2, as well as
biological agents targeting IL-12, IL-23 and Type I IFN, have been
approved for the treatment of multiple autoimmune diseases, making
TYK2 a highly validated target. TYK2 has a well-established
scaffolding function that plays a key role in cytokine receptor
surface expression and activation. By blocking both the catalytic
and scaffolding functions, degradation of TYK2 has the potential to
recapitulate the human loss-of-function biology of near full
pathway inhibition of Type I IFN, IL-12 and IL-23, while also
sparing IL-10/IL-22 and the ability to overcome the challenges of
small molecule inhibitors, which have limitations due to lack of
selectivity, limited target engagement, and/or lack of potent
activity against Type I IFN. KT-294 is a once daily, oral TYK2
degrader with a potential biologics-like efficacy profile, to
address conditions such as inflammatory bowel disease, psoriasis,
psoriatic arthritis, and lupus, among others.
1Gangolli et al., SID 2022
About Kymera TherapeuticsKymera is
a clinical-stage biotechnology company pioneering the field of
targeted protein degradation (TPD) to develop medicines that
address critical health problems and have the potential to
dramatically improve patients’ lives. Kymera is deploying TPD to
address disease targets and pathways inaccessible with conventional
therapeutics. Having advanced the first degrader into the clinic
for immunological diseases, Kymera is focused on delivering oral
small molecule degraders to provide a new generation of convenient,
highly effective therapies for patients with these conditions.
Kymera is also progressing degrader oncology programs that target
undrugged or poorly drugged proteins to create new ways to fight
cancer. Founded in 2016, Kymera has been recognized as one of
Boston’s top workplaces for the past several years. For more
information about our science, pipeline and people, please visit
www.kymeratx.com or follow us on X (previously 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 its clinical
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 first half of 2027. 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-621 and KT-294; 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 & Media Contact:
Justine KoenigsbergVice President, Investor
Relationsinvestors@kymeratx.commedia@kymeratx.com 857-285-5300
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