Kymera Therapeutics Outlines Key 2024 Objectives and Strategy to Progress Leading Portfolio of Immunology and Oncology Programs
09 Enero 2024 - 8:17AM
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 its corporate goals for 2024, including anticipated
progress on its best-in-class pipeline of immunology and oncology
programs.
“Kymera has taken important steps toward our goal of building a
fully integrated, global biotechnology company, demonstrating our
ability to consistently deliver first- and best-in-class programs
that target validated pathways with the potential to address large,
underserved disease areas and create significant value for patients
and shareholders,” said Nello Mainolfi, Ph.D., Founder, President
and CEO, Kymera Therapeutics. “We’re building an industry-leading
oral immunology portfolio, beginning with our IRAK4 degrader,
KT-474, which we expect to complete enrollment in two Phase 2
studies later this year, and continuing with our recently announced
oral STAT6 and TYK2 degrader programs, which have the potential to
revolutionize how we treat many immuno-inflammatory diseases using
oral medicines with biologics-like efficacy. In addition, we are
advancing our two novel oncology programs targeting STAT3 and MDM2,
both of which we expect to deliver additional proof-of-concept data
and comprehensive Phase 1 data in 2024, giving us multiple clinical
catalysts in the year ahead.”
Dr. Mainolfi continued, “Importantly, we have in excess of $745
million of cash1, providing expected runway now into the first half
of 2027. This will enable us to deliver the next stage of the
company’s growth and is expected to take the company past our Phase
2 data for KT-474, our oncology proof-of concept readouts, and
several clinical inflection points for our two recently-announced
immunology programs, STAT6 and TYK2.”
Kymera’s corporate goals for 2024 include:
Immunology Portfolio
Kymera is working to build an industry-leading oral immunology
pipeline by leveraging its disease agnostic discovery platform,
deep expertise gained through the development of its first-in-class
IRAK4 program, and unique target selection strategy that focuses on
genetically and clinically validated pathways, to build a portfolio
of oral medicines with efficacy comparable to in-pathway
biologics.
- Collaborate with Sanofi to complete enrollment of the
KT-474/SAR444656 (IRAK4) Phase 2 hidradenitis suppurativa and
atopic dermatitis clinical trials, with topline data expected to be
reported in the first half of 2025KT-474 (SAR444656) is an
oral IRAK4 degrader, in development for the treatment of
IL-1R/TLR-driven complex inflammatory diseases. 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. Kymera has an option after Phase 2 and prior to the
first Phase 3 study to opt in and equally share development and
commercialization costs and profits in the U.S. while retaining
tiered royalties in the rest of the world.
- Initiate dosing in the KT-621 (STAT6) Phase 1 trial in
the second half of 2024, with Phase 1 data expected to be reported
in 2025KT-621 has shown in preclinical studies to be a
potent (picomolar), oral degrader of STAT6, the only specific
transcription factor responsible for IL-4/IL-13 signaling and the
central driver of Type 2 inflammation in allergic diseases, with in
vitro and in vivo efficacy similar or superior to dupilumab. KT-621
has potentially broad utility across a number of allergic diseases,
including atopic dermatitis, asthma and chronic obstructive
pulmonary disorder, among others.
- Complete activities to enable IND filing and initiate
dosing in the KT-294 (TYK2) Phase 1 clinical trial in the first
half of 2025, with Phase 1 data expected to be reported in
2025KT-294 has shown in preclinical studies to be a potent
oral degrader of TYK2, 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. 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. KT-294, with a potential
biologic-like efficacy profile, has the opportunity to address
conditions such as inflammatory bowel disease, psoriasis, psoriatic
arthritis and lupus, among others.
Oncology Portfolio
Kymera is progressing degrader programs in oncology that target
undrugged or poorly drugged proteins in an effort to create new
ways to fight cancer that improve the standard of care and have the
potential treat both solid and liquid tumors.
- Complete the KT-333 (STAT3) Phase 1a study and deliver
additional proof-of-concept data to inform the program’s next
development steps in 2024KT-333 is designed as a potent
degrader of STAT3, a transcriptional regulator that has been linked
to numerous cancers as well as to inflammatory and autoimmune
diseases. KT-333 is being developed for the treatment of
STAT3-dependent hematological malignancies and solid
tumors. At the American Society of Hematology annual meeting,
the Company disclosed the first proof-of-concept data for single
agent KT-333 anti-tumor activity in hematological malignancies as
well as potential anti-tumor immuno-modulatory effects in both
tumor biopsies and blood.
- Complete the KT-253 (MDM2) Phase 1a study and deliver
proof-of-concept data, which will inform a patient stratification
strategy for the program in 2024KT-253 is a highly potent
and selective degrader that targets MDM2, the crucial regulator of
the most common tumor suppressor, p53. A Phase 1 study of KT-253 is
ongoing, with one arm in patients with relapsed or refractory solid
tumors and lymphomas, and a second arm focused on patients with
high grade myeloid malignancies and acute lymphocytic leukemia
(ALL). Interim data from the study demonstrated evidence of target
engagement and p53 pathway activation, as well as initial antitumor
activity and a lack of the traditional hematological toxicity seen
with small molecule inhibitors. Kymera is working to develop a
biomarker-based patient selection strategy for subsequent
development beyond Phase 1a.
Research and Platform
- Continue to advance, from early discovery through
preclinical development, a series of high value programs in areas
of unmet need with large patient populations and target classes
best suited for TPD
J.P. Morgan Healthcare Conference Webcast
Kymera will present its 2024 outlook at the 42nd
Annual J.P. Morgan Healthcare Conference on Tuesday,
January 9, at 9:00 a.m. PT (12:00 p.m. ET). A live
webcast of the presentation and Q&A breakout session will be
available by visiting the Investors section
of Kymera’s website at www.kymeratx.com. A replay of
the webcast will be archived on Kymera’s website for
30-days following the presentation.
Additional information about Kymera’s pipeline product
opportunities is available in the Pipeline section of the Company’s
corporate website.
1Unaudited, estimated cash as of January 9, 2024, inclusive of
$301 million of net proceeds from the company’s recently-closed
equity offering and a $15 million payment received from Sanofi for
a Phase 2 dosing milestone achieved in 4Q23.
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 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-474 (SAR444656), KT-621, KT-294, KT-333 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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