Kymera Therapeutics Announces First Patient Dosed in Phase 2 Atopic Dermatitis Clinical Trial of KT-474 (SAR444656), a First-in-Class, Investigational IRAK4 Degrader, Generating a $15 Million Payment from Sanofi
07 Diciembre 2023 - 6:00AM
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 (ADVANTA) evaluating KT-474 (SAR444656) in AD,
generating a $15 million milestone payment under its collaboration
with Sanofi. The Phase 2 study will evaluate the efficacy and
safety of KT-474, a first-in-class, investigational IRAK4 degrader,
compared with placebo in adult patients with moderate to severe AD.
Sanofi is conducting Phase 2 KT-474 studies in both AD and HS, and
dosed the first HS patient in October 2023, which generated a $40
million milestone payment under the terms of the collaboration.
Study completion dates for both trials are projected in the first
quarter of 2025.
“The initiation of dosing in the second Phase 2 trial of KT-474
reinforces the potential of degrading IRAK4 in the treatment of
multiple immunological and inflammatory diseases, and the promise
of TPD to offer patients with complex inflammatory diseases a new
way to manage their disease,” said Nello Mainolfi, PhD, Founder,
President and CEO, Kymera Therapeutics. “Our focus has always been
on genetically validated targets within pathways with clear
clinical validation and where TPD offers the best or the only path
to creating an effective treatment, and we believe our IRAK4
degrader has the potential to offer AD patients a well-tolerated,
effective, and convenient oral medicine. We look forward to sharing
updates as our partner Sanofi progresses this program.”
“While we’ve made great strides in the treatment of AD, there
continues to be an opportunity to advance a diverse range of
solutions that address unmet needs across the spectrum of patients
suffering from this chronic condition,” said Naimish Patel, MD,
Head of Global Development, Immunology and Inflammation, Sanofi.
“We are pleased to be working with Kymera to explore the potential
of IRAK4 degradation to treat a variety of inflammatory conditions,
including in our recently initiated Phase 2 AD and HS trials.”
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. The Phase 1 clinical trial results were
recently published in Nature Medicine and showed evidence of robust
IRAK4 degradation in the blood and active skin lesions of HS and AD
patients and a favorable safety profile. 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 (NCT06058156) can be found at www.clinicaltrials.gov.
About Atopic Dermatitis AD is the most common
form of eczema, a chronic inflammatory disease that causes the skin
to become inflamed and irritated, making it extremely pruritic
(itchy). AD is a common condition that usually begins in childhood;
however, anyone can get the disease. It can affect a patient’s
quality of life and lead to additional complications, such as
infections and sleep loss. While there are currently available
medicines for AD, there is a significant opportunity to improve
treatment for patients not effectively treated with currently
available options.
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 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 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 second half of 2025. The words "may," “might,”
"will," "could," "would," "should," "expect," "plan," "anticipate,"
"intend," "believe," “expect,” "estimate," “seek,” "predict,"
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these identifying words. Any forward-looking statements in this
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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); 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 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 |
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