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Kymera Gets Orphan Drug Status For Rare Blood Cancer Candidate
Kymera Gets Orphan Drug Status For Rare Blood Cancer Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kymera Therapeutics' (NASDAQ:KYMR) product candidate KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL).
KT-333 is being evaluated in an ongoing Phase 1 clinical trial to assess safety, tolerability and PK/PD of escalating doses in adult patients with relapsed/refractory liquid and solid tumors, including aggressive lymphomas.
Nello Mainolfi, Co-Founder, President and CEO, commented: "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. 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."
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.
Kymera received orphan drug designation for KT-333 in the treatment of Peripheral T-cell Lymphoma (PTCL) earlier this year.
FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer U.S. patients annually.
Price Action : Kymera shares closed Wednesday's trading higher 2.17 percent at $27.81.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kymera Therapeutics' (NASDAQ:KYMR) product candidate KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL).
美国食品和药物管理局已批准凯美乐治疗公司(纳斯达克代码:KYMR)的候选产品KT-333用于治疗皮肤T细胞淋巴瘤。
KT-333 is being evaluated in an ongoing Phase 1 clinical trial to assess safety, tolerability and PK/PD of escalating doses in adult patients with relapsed/refractory liquid and solid tumors, including aggressive lymphomas.
KT-333正在进行的第一阶段临床试验中进行评估,以评估在患有复发/难治性液体和固体肿瘤(包括侵袭性淋巴瘤)的成年患者中逐步增加剂量的安全性、耐受性和PK/PD。
Nello Mainolfi, Co-Founder, President and CEO, commented: "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. 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."
联合创始人、总裁兼首席执行官内洛·迈诺尔菲评论说:“第二个孤儿药物指定加强了KT-333的潜力,通过靶向STAT3,一种一直被认为不可用药的蛋白质,KT-333将影响一系列血液和实体肿瘤患者的生活。我们有一个重要的机会提供一种具有这种一流的异双功能降解剂的重要新药,我们期待着与淋巴瘤社区合作,在CTCL中迅速推进KT-333,并探索其在其他癌症中的潜力。”
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.
KT-333是转录调控基因STAT3的一种一流降解剂。STAT3信号的失控与包括CTCL在内的多种癌症的发病机制有关。
Kymera received orphan drug designation for KT-333 in the treatment of Peripheral T-cell Lymphoma (PTCL) earlier this year.
Kymera在今年早些时候获得了治疗外周T细胞淋巴瘤(PTCL)的KT-333的孤儿药物名称。
FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer U.S. patients annually.
FDA授予孤儿称号,以促进一种药物的开发,这种药物预计将比现有的治疗方法具有显著的治疗优势,这些治疗方法针对的是每年影响20万或更少美国患者的疾病。
Price Action : Kymera shares closed Wednesday's trading higher 2.17 percent at $27.81.
价格行动:Kymera股价周三收盘上涨2.17%,至27.81美元。
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