Kymera Therapeutics Receives U.S. FDA Fast Track Designation for KT-333, a First-in-Class, Investigational
Degrader for the Treatment of
Relapsed/Refractory Cutaneous T-Cell Lymphoma
Relapsed/Refractory Peripheral T-Cell Lymphoma

Phase 1Fast TrackOrphan DrugClinical Result
Kymera Therapeuticsncology trial ongoing with an update includingKT-333al evaluation of its clinical antitu
cDegradern patients expected in
Relapsed/Refractory Cutaneous T-Cell Lymphoma
Relapsed/Refractory Peripheral T-Cell Lymphoma
KT-333t Track designation can potentially accelerate KT-333’s development path for the treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinicKT-333ge biopharmaceutical company advancing ta
R/R Cutaneous T-Cell Lymphoma
R/R Peripheral T-Cell Lymphoma
in degrader medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-333 for the treatment of R/R Cutaneous T-cell Lymphoma (CTCL) and R/R Peripheral T-cell Lymphoma (PTCL).
KT-333 is a highly selective degrader of STAT3 in develKymera Therapeutics, Inc.of multiple STAT3-dependent pathologies, including hematological malignancies and solid tumors. STAT3 is a transcriptional regulator that has been linked to numerous cancers as well asU.S. Food and Drug Administration (FDA)s. In 2022, KT-333 received FDA orphan KT-333esignation for the tre
R/R Cutaneous T-cell Lymphoma (CTCL)
R/R Peripheral T-cell Lymphoma (PTCL)
KT-333T-333 Fast Track designation highli
the promise of degrading STAT3, a protein that has historically been undruggable, for
hematological malignancies
solid tumors
id Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics.
k forward to pr
inflammatory and autoimmune diseases
e 1 clinicaKT-333l later this year, including initial evaluation of its antitumor
ivity in the target patient populations, and to working with the lymphoma community to rapidly advance this first-in-class heterobifunctional degrader in CTCL and PTCL in addition to exploring its potential in other cancers.”
The FKT-333ast Track process is designed to get important new medicines
atients more quickly, facilitating the development and expediting the review of therapi
ntended to treat serious conditions and address unmet mediKymera Therapeuticss whose programs are granted Fast Track designatiKT-333 eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant
are met. For more information on the Fast Track process, please visit the FDA’s
cial website.
About the KT-333 Clinical Program
The Phase KT-333ical trial of KT-333 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 dosed weekly in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. In June at the International Conference on Malignant Lymphoma (ICML), with a data cutoff date of May 1, 2023, Kymera presented data on thirteen patients who received a mean of five doses across the first four dose levels (DL1-4) of the trial, including patients with solid tumors, CTCL and PTCL. With DL4 still open to accrual at the time of the presentation, data reported from DL1-3 found plasma exposure increased with dose, reaching levels close to those predicted to be efficacious, and demonstrated dose-dependent STAT3 degradation with up to 88% mean maximum reduction in peripheral blood mononuclear cells and degradation profiles at DL3 near levels of knockdown that led to antitumor activity in preclinical models. We shared at ICML that there were no dose-limiting toxicities observed in the study. The Phase 1a dose escalation stage is ongoing, recruiting broadly across solid and liquid tumors, and more information can be found at, identifier NCT05225584.
About Cutaneous T-Cell LymphomKT-333KT-333
solid tumors
Malignant Lymphoma
solid tumors
solid and liquid tumors
Cutaneous T-Cell Lymphoma
) is a general term for non-Hodgkin’s T-cell lymphomas that are primarily characterized by an abnormal accumulation of T-cells in the skin and can involve the blood, lymph nodes and other internal organs. Approximately 3,000 CTCL patients are diagnosed in the U.S. each year, and CTCL accounts for 25% of T-cell lymphomas in the U.S. CTCL is a typically slow-growing cancer, with symptoms such as dry skin, potentially severe itching, rashes and enlarged lymph nodes. Since symptoms and skin biopsy findings are similar to other skin conditions, early-stage diagnosis can be difficult.
Cutaneous T-cell lymphoma (CTCL)
non-Hodgkin’s T-cell lymphomas
T-cell lymphomas
dry skin
enlarged lymph nodes
Peripheral T-cell Lymphoma
lymphoma, is a heterogenous group of tumors that arise from mature T-cells in the lymphoid tissues in areas such as the lymph nodes, lungs, gastrointestinal tract and skin. Approximately 4,000-8,000 PTCL patients are diagnosed in the U.S. each year, and PTCL accounts for 15% to 20% of aggressive lymphomas in the U.S. PTCL carries a poorer prognosis than other non-Hodgkin’s lymphomas since it is less responsive to standard chemotherapy regimens.
About Kymera Therap
non-Hodgkin’s lymphoma
aggressive lymphomas
non-Hodgkin’s lymphomas
KymeraKymera Therapeuticsical 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.
Kymerad 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 JournalKymerae of Boston’s top workplaces. For more information about our people, science and pipeline, please visit or follow us on Twitter or LinkedIn.KymeraKymera
MDM2 oncoprotein
immune-inflammatory diseases
hematologic malignancies
solid tumors
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Cutaneous T-Cell Lymphoma,Peripheral T-Cell Lymphoma,Hematologic Neoplasms
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