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Kymera Therapeutics Earns U.S. FDA Fast Track Designation for KT-333

Tuesday, September 19, 2023

Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company specializing in the advancement of targeted protein degradation for the development of novel small molecule protein degrader drugs, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for KT-333 in the treatment of Relapsed/Refractory Cutaneous T-cell Lymphoma (CTCL) and Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL).

KT-333 is a highly selective degrader of STAT3 that is currently in development for the treatment of various STAT3-dependent diseases, including hematological malignancies and solid tumors. STAT3 is a transcriptional regulator associated with numerous cancers and inflammatory/autoimmune diseases. In 2022, KT-333 received FDA orphan drug designation for both CTCL and PTCL treatment.

Dr. Jared Gollob, Chief Medical Officer at Kymera Therapeutics, highlighted the potential of degrading STAT3, which has historically been considered "undruggable," as a promising approach for CTCL and PTCL patients. The company anticipates providing an update on the KT-333 Phase 1 clinical trial later this year, including the initial evaluation of its antitumor activity in the target patient populations. They also expressed their commitment to collaborating with the lymphoma community to advance this groundbreaking heterobifunctional degrader in CTCL and PTCL and explore its potential in other cancer types.

The FDA's Fast Track designation is designed to expedite the development and review of therapies for serious conditions and unmet medical needs. It allows for more frequent interactions between the company and the FDA during clinical development and may potentially lead to accelerated approval and/or priority review.

The Phase 1 clinical trial of KT-333 is designed to assess its safety, tolerability, pharmacokinetics/pharmacodynamics, and clinical activity when administered weekly to adult patients with relapsed and/or refractory lymphomas, leukemias, and solid tumors. Data presented at the International Conference on Malignant Lymphoma (ICML) in June 2023 indicated encouraging results, including dose-dependent STAT3 degradation and the absence of dose-limiting toxicities. The Phase 1a dose escalation stage is ongoing and is actively recruiting patients across a range of solid and liquid tumors. 

CTCL represents a group of non-Hodgkin's T-cell lymphomas characterized by an abnormal accumulation of T-cells in the skin, potentially affecting blood, lymph nodes, and internal organs. Approximately 3,000 CTCL patients are diagnosed in the U.S. each year, with symptoms including dry skin, severe itching, rashes, and enlarged lymph nodes, often leading to challenges in early diagnosis due to similarities with other skin conditions.

PTCL, a subtype of non-Hodgkin's lymphoma, encompasses a heterogeneous group of tumors originating from mature T-cells in lymphoid tissues such as lymph nodes, lungs, gastrointestinal tract, and skin. PTCL accounts for 15% to 20% of aggressive lymphomas in the U.S., presenting a poorer prognosis compared to other non-Hodgkin's lymphomas due to limited responsiveness to standard chemotherapy regimens.

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