Business
Kymera Therapeutics Receives FDA Orphan Drug Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma is the second orphan drug designation for KT-333 WATERTOWN, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc.
About this update from Kymera Therapeutics, Inc.
[{"type":"text","content":"Cutaneous T-Cell Lymphoma is the second orphan drug designation for KT-333\nWATERTOWN, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL). KT-333 is a first-in-class degrader of the transcriptional regulator STAT3. Deregulation of STAT3 signaling has been implicated in the pathogenesis of a variety of cancers, including CTCL. There are currently no approved therapies for CTCL that target this pathway. KT-333 received orphan drug designation for the treatment of Peripheral T-cell Lymphoma (PTCL) earlier this year. “This second orphan drug designation reinforces the potential of KT-333 to impact the lives of a broad range of patients with hematological and solid tumors by targeting STAT3, a protein that has been considered undruggable,” said Nello Mainolfi, Co-Founder, President and CEO of Kymera Therapeutics. “We have a significant opportunity to deliver an important new medicine with this first-in-class heterobifunctional degrader, and we look forward to working with the lymphoma community to rapidly advance KT-333 in CTCL and exploring its potential in other cancers.” The safety, tolerability and PK/PD of escalating doses of KT-333 are currently being evaluated in an ongoing Phase 1 clinical trial in adult patients with relapsed/refractory liquid and solid tumors, including aggressive lymphomas. The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. About Cutaneous T-Cell LymphomaCutaneous T-cell lymphoma (CTCL) 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 which account for approximately 25 percent of...