![]() We shared at ICML that there were no dose-limiting toxicities observed in the study. ![]() 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 D元 near levels of knockdown that led to antitumor activity in preclinical models. 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. The Phase 1 clinical 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. For more information on the Fast Track process, please visit the FDA’s official website. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met. The FDA’s Fast Track process is designed to get important new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. “We look forward to providing an update on the KT-333 Phase 1 clinical trial later this year, including initial evaluation of its antitumor activity 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 KT-333 Fast Track designation highlights the promise of degrading STAT3, a protein that has historically been undruggable, for the treatment of patients with CTCL and PTCL,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. In 2022, KT-333 received FDA orphan drug designation for the treatment of both CTCL and PTCL. STAT3 is a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases. KT-333 is a highly selective degrader of STAT3 in development for the treatment of multiple STAT3-dependent pathologies, including hematological malignancies and solid tumors. 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). ![]() (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. 18, 2023 (GLOBE NEWSWIRE) - Kymera Therapeutics, Inc. KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical antitumor activity in patients expected in the fourth quarter of 2023įast 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
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