辯證法

2022年3月17日,

達拉斯,TX /價值/——辯證療法,Inc .(辯證®),一個德克薩斯州的臨床階段生物科技公司專注於創造創新的新技術來治療癌症,今天宣布,美國食品和藥物管理局(FDA)批準孤兒藥物名稱DT2216治療t細胞淋巴瘤。DT2216是辯證法的第一代複合使用其專有的和小說構建凋亡蛋白靶向降解(APTaD™)技術平台。“這是一個重要的裏程碑DT2216的發展,我們的首席APTaD™化合物。FDA的決定給予孤兒藥名稱突顯出我們相信DT2216可能是一個有前途的治療t細胞淋巴瘤患者“大衛Genecov博士說,辯證法的總裁兼首席執行官。“有一個關鍵的未滿足的需要人被診斷出患有這種罕見的癌症,在當前批準治療反應率相對較低”。正常t細胞需要BCL-XL表達胸腺選擇在他們的生存發展。後胸腺選擇BCL-XL不再正常t細胞表達BCL-XL。然而,許多t細胞淋巴瘤dy BCL-XL作為腫瘤的一種機製轉換和允許他們繼續生存的惡性腫瘤。研究已經證明了在t細胞淋巴瘤BCL-XL生存的重要性。辯證法表明DT2216 t細胞淋巴瘤是一種有效的治療在臨床前研究。 The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About DT2216 and the APTaD™ Technology Platform DT2216 is currently being investigated in a Phase 1 clinical trial designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. Patients in the Phase 1 trial will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622) . In preclinical studies DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various in vitro models of hematologic and solid tumors as a single agent and in combination with other chemotherapeutic agents. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with less impact on platelets. As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD™ technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need. About Dialectic Therapeutics, Inc. Dialectic is a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer. Our goal is to relieve the suffering of patients with cancer and prolong their productive lives through targeted therapies with limited toxicities and complications. Based in Dallas, Texas, Dialectic has research partners and facilities at UT Health San Antonio and University of Florida Health. Biotech venture investors John D. Harkey, Jr. and Dr. David Genecov capitalized the Company in 2018 and are co-founders along with Dr. Robert Hromas, Dean of the Long School of Medicine at UT Health San Antonio, Dr. Daohong Zhou, Director of Center for Innovative Drug Discovery at UT Health San Antonio, and Dr. Guangrong Zheng at University of Florida College of Pharmacy. Dialectic has also been supported to date through a Seed Award for Product Development Research from CPRIT and a recently awarded Texas Company Product Development Research grant from CPRIT for continued clinical development of DT2216. For more information regarding Dialectic, please visit www.dtsciences.com. Dialectic is a registered trademark of Dialectic Therapeutics, Inc. Source: Dialectic Therapeutics