Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage
biopharmaceutical company advancing a new class of small molecule
medicines using targeted protein degradation (TPD), today shared
new data from its ongoing KT-333 Phase 1 trial. KT-333, a
first-in-class, potent, highly selective, heterobifunctional small
molecule degrader of STAT3, demonstrated early signs of antitumor
activity at doses that were generally well-tolerated and associated
with substantial STAT3 knockdown in blood and tumor. The data were
presented at the American Society of Hematology (ASH) 65th Annual
Meeting and Exposition taking place from December 9-12, 2023, in
San Diego, California.
“We’re encouraged by the data from the Phase 1 trial showing
consistent fidelity of translation from preclinical models to
patients, including STAT3 degradation in blood and tumor, induction
of IFN-γ response signature, and antitumor responses in CTCL and
Hodgkin’s lymphoma, which we believe supports the potential of
KT-333 to address both hematological malignancies as a single agent
and solid tumors as a potential novel combination partner with
anti-PD-1 drugs,” said Jared Gollob, M.D., Chief Medical Officer,
Kymera Therapeutics. “We look forward to completing the dose
escalation portion of the Phase 1 study in 2024 and sharing
additional updates on this first-in-class program across a range of
indications at future medical meetings.”
KT-333 STAT3 Clinical Update
KT-333 degrades STAT3, a transcriptional regulator that has been
linked to numerous cancers, as well as to inflammatory and
autoimmune diseases, and is being developed for the treatment of
STAT3-dependent hematological malignancies and solid tumors. The
Phase 1 clinical trial is evaluating the safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity
of KT-333 dosed weekly on 28-day cycles in adult patients with
relapsed and/or refractory lymphomas, leukemias and solid
tumors.
The poster provides an interim update with a data cut-off as of
October 18, 2023. Twenty-nine patients were treated across five
dose levels (DL1-5) with a mean of eight doses, including five with
cutaneous T-cell lymphoma (CTCL), two with large granular
lymphocytic leukemia (LGL-L), one each with peripheral T-cell
lymphoma (PTCL), B-cell and Hodgkins’s lymphoma, and nineteen with
a variety of solid tumor malignancies. Dose escalation is ongoing
at DL5 in solid tumor/lymphoma patients and at DL3 in leukemia
patients. Dr. Aditi Shastri from Montefiore Medical Center and
Albert Einstein College of Medicine, a lead investigator in the
study, presented the interim Phase 1 findings. Highlights from the
poster presentation include:
- A partial response (PR) was observed in one patient with
Hodgkin’s lymphoma, and two PRs and one stable disease were
reported among the five CTCL patients treated. Stable disease was
observed in four patients with advanced solid tumors, including two
head and neck cancer patients as well as patients with
cholangiocarcinoma and renal cell cancer.
- KT-333 was generally well tolerated with primarily Grade 1 and
2 adverse events which included constipation, fatigue, nausea and
anemia. The only KT-333 related adverse events that were Grade 3 or
higher were stomatitis, arthralgia, and decreased weight in one
patient each. Two dose-limiting toxicities (DLTs), stomatitis and
arthralgia, occurred in LGL-L patients at DL5 and no DLTs were
observed in solid tumor/lymphoma patients. Based on these findings,
the study protocol was revised to continue dose escalation in solid
tumor and lymphoma patients separately from patients with leukemia,
including LGL-L and T-cell prolymphocytic leukemia (T-PLL)
patients. The study continues to enroll solid tumor/lymphoma
patients at DL5 and LGL-L/T-PLL patients at DL3.
- KT-333 achieved maximum degradation up to 96% in peripheral
blood mononuclear cells at DL4-5 and with evidence of STAT3 pathway
inhibition and downregulation of inflammatory biomarkers in
peripheral blood.
- A critical cytokine involved in anti-tumor immunity, IFNγ, as
well as IFNγ-stimulated genes, were induced in peripheral blood
showing functional engagement of the JAK/STAT pathway, similar to
preclinical studies.
- KT-333 resulted in substantial reduction of STAT3, pSTAT3 and
SOCS3 in a CTCL patient tumor with concomitant induction of
IFNγ-stimulated genes, suggestive of positive immunomodulatory
response in the tumor microenvironment that both clinically and
preclinically has been shown to enhance the activity of anti-PD-1
drugs, supporting potential expansion into combinations of KT-333
and anti-PD-1 agents.
Preclinical data demonstrating the potential of STAT3 protein
degraders as a therapeutic approach in venetoclax-resistant Acute
Myeloid Leukemia was also presented at the meeting.
A copy of the poster presentation, entitled “Preliminary Safety,
Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333,
a Targeted Protein Degrader of STAT3, in Patients with Relapsed or
Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and
Solid Tumors” is available in the Scientific Resources section of
Kymera's website.
More information on the Phase 1 study can be found at
www.clinicaltrials.gov, identifier NCT05225584.
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 (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, including those
for KT-333; expectations regarding timing, success and data
announcements of current ongoing preclinical and clinical trials,
including those for KT-333; 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-333; 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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