R&D Day Highlights Kymera’s Immunology Strategy and Emerging Pipeline of Novel, First-in-Class Oral Degraders Addressing Multiple Highly Prevalent Immuno-inflammatory Diseases
04 Janvier 2024 - 1:00PM
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing a new class of small molecule
medicines using targeted protein degradation (TPD), today will
share an overview of its strategy to build the industry leading
immunology pipeline of oral degrader medicines that target
validated pathways and demonstrate efficacy comparable to biologic
therapies. As part of its strategy, Kymera is unveiling two new
programs that each have the potential to address multiple
immune-mediated diseases, each with considerable market potential.
The new programs target STAT6, the obligate and specific
transcription factor of the IL-4/13 pathway, and TYK2, the key
scaffolding kinase of the IL-23/IFN pathways. These represent two
essential signaling nodes in genetically and clinically validated
pathways driving inflammation in autoimmune diseases that are
undrugged or inadequately drugged with other
technologies. Kymera will share its immunology strategy,
including market insights, program updates, new preclinical data
and development timelines, at its virtual R&D Day this morning.
“We believe that Kymera is on the way to revolutionizing the
treatment of complex immuno-inflammatory diseases by leveraging our
disease agnostic platform to build a best-in-industry pipeline of
oral immunology medicines with biologics-like efficacy and enormous
market potential,” said Nello Mainolfi, Ph.D., Founder, President
and CEO, Kymera Therapeutics. “With critical insights from our
KT-474 program, a unique target selection strategy and the ability
to block key, validated pathways with a degrader approach that has
the potential to be superior to traditional small molecules and
comparable to approved biologics, we can deliver on our vision to
create transformative therapies that will expand the number of
patients who can be treated.”
The R&D Day presentation will focus on three first-in-class
oral degrader immunology programs, including Kymera’s new,
wholly-owned STAT6 (KT-621) and TYK2 (KT-294) degraders and its
IRAK4 degrader (KT-474):
- KT-621 (STAT6): STAT6 is an essential
transcription factor specific to the IL-4/IL-13 signaling pathway
and the central driver of Type 2 inflammation in allergic diseases.
STAT6 is a genetically validated target and the pathway has been
clinically validated by approved IL-4/IL-13-targeting biologics,
including dupilumab. In preclinical studies, KT-621, Kymera’s
first-in-class oral STAT6 degrader, demonstrated full inhibition of
the IL-4/IL-13 pathway in all relevant human cell contexts with
picomolar potency that was superior to dupilumab, and equivalent or
superior efficacy to dupilumab in multiple preclinical efficacy
studies. In addition, at low oral doses, KT-621 demonstrated near
full in vivo STAT6 degradation and was well-tolerated in multiple
preclinical toxicity studies. KT-621, a once daily oral small
molecule degrader with a preclinical biologics-like efficacy
profile, has the potential to have broad activity across multiple
diseases, including atopic dermatitis, asthma, chronic obstructive
pulmonary disorder, eosinophilic esophagitis and chronic
rhinosinusitis with nasal polyps, among others. The Company expects
to initiate a Phase 1 clinical trial in the second half of 2024 and
report the Phase 1 results in 2025.
- KT-294 (TYK2): TYK2 is a member of the Janus
Kinase (JAK) family required for Type I interferon (IFN), IL-12 and
IL-23 signaling with both genetic and clinical validation in
autoimmune and inflammatory diseases. TYK2 has a well-established
scaffolding function that plays a key role in cytokine receptor
surface expression and activation. In preclinical studies, KT-294,
Kymera’s first-in-class oral TYK2 degrader, demonstrated picomolar
to nanomolar potencies across all relevant human cell contexts
evaluated, representing what Kymera believes is the only approach
to TYK2 targeting that 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. Degradation of TYK2
has the potential 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, a once daily oral small molecule degrader with
a potential biologics-like efficacy profile, has the opportunity to
address conditions such as inflammatory bowel disease, psoriasis,
psoriatic arthritis and lupus, among others. Kymera intends to
initiate a Phase 1 clinical trial in the first half of 2025
and report the Phase 1 results in 2025.
- KT-474/SAR444656 (IRAK4): KT-474 is a
first-in-class IRAK4 degrader in Phase 2 clinical trials for the
treatment of hidradenitis suppurativa (HS) and atopic dermatitis
(AD). IRAK4 is a key scaffolding protein of the myddosome complex
that mediates signaling through IL-1 receptors (IL-1R) and
toll-like receptors (TLR), which play a crucial role in
inflammation across multiple autoimmune diseases. In a Phase 1
trial published last November in Nature Medicine, KT-474
demonstrated robust degradation of IRAK4 in the blood and skin of
healthy volunteers and patients with HS and AD, which was
associated with a systemic anti-inflammatory effect and preliminary
evidence of clinical activity. Enrollment in both Phase 2 trials is
ongoing and anticipated to be completed in the fourth quarter of
2024, with topline data expected in the first half of 2025. Kymera
is collaborating with Sanofi on the development of KT-474.
Kymera R&D Day DetailsKymera will host a
webcast to discuss its emerging immunology pipeline from 10:00 a.m.
– 12:00 p.m. ET, Thursday, January 4, 2024. To join the webcast
please use this link. The slide presentation will be available
after the prepared remarks and before the question and answer
section of the webcast in the “News and Events ” section of the
Investors section of the Company’s website at www.kymeratx.com. The
replay of the event will be available shortly after the conclusion
of the meeting.
About Kymera Therapeutics Kymera 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 (formerly 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 by Kymera Therapeutics regarding its: strategy,
business plans and objectives for our clinical stage 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 first half of 2026. 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, including
those for KT-474, KT-621, and KT-294; 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; 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 Quarterly
Report on Form 10-Q for the quarterly period ended September 30,
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: Justine KoenigsbergVice
President, Investor
Relationsinvestors@kymeratx.com857-285-5300 |
Media Contact:Todd CooperSenior Vice President,
Corporate Affairsmedia@kymeratx.com857-285-5300 |
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