Kymera Therapeutics Announces First Patient Dosed in Phase 2 Hidradenitis Suppurativa Clinical Trial of KT-474 (SAR444656), a First-in-Class, Investigational IRAK4 Degrader, Generating $40 Million Payment from Sanofi
27 October 2023 - 10:00PM
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing a new class of small molecule
medicines using targeted protein degradation (TPD), today announced
that the first patient has been dosed in the randomized Phase 2
clinical trial in hidradenitis suppurativa (HS) evaluating KT-474
(SAR444656), a first-in-class, investigational IRAK4 degrader. The
Phase 2 study will evaluate the efficacy, safety, pharmacokinetics,
and biological effects of KT-474 compared with placebo in adult
patients with moderate to severe HS. Kymera’s partner Sanofi is
conducting the Phase 2 study in HS, and has initiated a second
randomized Phase 2 trial in AD. Under the terms of the
collaboration, dosing of the first patient in the HS trial
generated a milestone payment of $40 million. Dosing of the first
patient in the AD trial will also generate a milestone payment to
Kymera.
“The initiation of dosing in the first Phase 2 trial of KT-474
in HS is an important step in the development of this molecule and
a significant achievement for Kymera in demonstrating the potential
of protein degradation to transform the treatment of complex,
inflammatory diseases with small molecules,” said Nello Mainolfi,
PhD, Founder, President and CEO, Kymera Therapeutics. “Based on the
encouraging KT-474 Phase 1 results, we believe that this molecule
has the potential to offer HS patients a well-tolerated and
effective oral drug. We look forward to sharing additional updates
as our partner Sanofi advances this program, including dosing the
first patient in the second Phase 2 trial in AD later this
quarter.”
“At Sanofi, we’ve very excited about the potential of protein
degraders to deliver new treatments for immunological and
inflammatory diseases by selectively targeting specific proteins
and critical pathways, like IRAK4,” said Naimish Patel, MD, Head of
Global Development, Immunology and Inflammation, Sanofi. “HS is a
chronic, debilitating skin disease whereby there remains a
tremendous need for new treatment options. We look forward to
progressing the Phase 2 program in HS and AD.”
About KT-474
KT-474 is an oral IRAK4 degrader, in development for the
treatment of IL-1R/TLR-driven complex inflammatory diseases where
there is an opportunity to significantly advance the standard of
care, including HS and AD. In the Phase 1 trial, KT-474 showed
evidence of robust IRAK4 degradation in the blood and active skin
lesions of HS and AD patients and was generally well tolerated.
Treatment with KT-474 was associated with a systemic
anti-inflammatory response and improvement in skin lesions and
symptoms in both HS and AD patients, with internal consistency
between the effect on inflammatory biomarkers and impact on
clinical endpoints. KT-474 was generally safe and well-tolerated,
with no serious adverse events, no drug-related infections, and no
dose interruptions or discontinuations due to adverse events.
The safety and efficacy of KT-474 (SAR444656) is currently being
evaluated in double blind, placebo-controlled, randomized Phase 2
clinical trials in adult patients with moderate to severe HS and
AD. Sanofi, which is collaborating with Kymera on the development
of KT-474 outside of the oncology and immune-oncology fields, is
conducting the Phase 2 studies.
More information on the Phase 2 studies in HS (NCT06028230) and
AD (NTC06058156) can be found at www.clinicaltrials.gov.
About Hidradenitis Suppurativa Hidradenitis
suppurativa (HS) is a chronic inflammatory skin disease that causes
painful lumps deep in the skin. It results in painful nodules and
abscesses that can persist and worsen over time. It can affect
daily life and emotional well-being, especially as the disease
progresses. HS tends to start after puberty, usually before age 40.
There are no FDA approved oral treatments for HS.
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 X (formerly 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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