創勝集團-B(06628.HK)於2022年ASCO GI及IGCC公佈TST001 I期臨牀試驗最新業務進展
格隆匯1月12日丨創勝集團-B(06628.HK)公吿，董事會欣然宣佈TST001美國I期試驗將於2022年1月20日至1月22日在加州舊金山舉辦的2022年美國臨牀腫瘤學會胃腸道腫瘤研討會("ASCOGI")上通過Trial in Progress海報的方式展示。TST001中國I期試驗資料將於2022年3月6日至3月9日在德州休斯頓舉辦的2022年國際胃癌大會("IGCC")上以海報的形式公佈。
TST001是公司研發的高親和力人源化抗體。TST001針對表達Claudin18.2的腫瘤細胞顯示出強大的抗體依賴性細胞毒性體外活性，並且在中高水平的表達Claudin18.2的腫瘤模型中擁有良好的抗腫瘤活性。I期試驗自2020年4月起在中美兩地同時開展。
TST001已完成中國研究的劑量遞增階段，目前正在表達Claudin18.2的多種腫瘤類型(包括胃癌或胃食管連接部癌、胰腺癌及若干其他腫瘤類型)患者中進行Ib/IIa期單藥治療試驗。此外，TST001與化療或PD-1聯用用於一線及既往接受過治療的GC/GEJ患者的試驗亦正在進行。IGCC海報將公佈正在進行試驗的TST001劑量遞增階段的資料。
美國研究即將完成劑量遞增階段，並將擴展至表達Claudin18.2的癌症患者，其中TST001將同時用作多種腫瘤類型的單藥治療及與PD-1抑制劑聯用治療胃癌。ASCOGI海報TPS375將通過Trial in Progress展示美國試驗設計。
TST001是一種高親和力人源化抗Claudin18.2的單克隆抗體，具有增強的ADCC及補體依賴性細胞毒性("CDC")活性，並於腫瘤異種移植試驗中顯示出強大的抗腫瘤活性。TST001是全球範圍內開發的第二個Claudin18.2靶向抗體治療候選藥物。TST001乃使用本公司的免疫耐受突破(IMTB)技術平台開發。TST001通過ADCC及CDC機制殺死表達Claudin18.2的腫瘤細胞。利用先進的生物工藝技術，TST001的巖藻糖含量在生產過程中大大降低，進一步增強了TST001的NK細胞介導的ADCC活性。
中美兩地均一直在進行TST001的臨牀試驗(NCT04396821,NCT04495296/CTR20201281)。美國食品藥品監督管理局(FDA)已授予TST001於美國用於治療GC/GEJ患者的孤兒藥資格認定。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
