Aptamer Sciences Inc. Files IND Application for Innovative Liver Cancer Treatment AST-201: A Promising Approach to Address Under Medical Needs

2024-03-26
临床1期临床申请上市批准
SEONGNAM, South Korea, March 25, 2024 /PRNewswire/ -- Aptamer Sciences Inc. (KOSDAQ, 291650) announced the filing of an Investigational New Drug (IND) application for the phase 1 clinical trial of AST-201 with the Korean Ministry of Food and Drug Safety on March 12th, 2024.
Continue Reading
AST-201 structure & mechanism of action
AST-201, the company's pioneering candidate in its pipeline, is an ApDCTM (Aptamer-Drug Conjugate) designed to target GPC3 protein, which exhibits high expression levels in specific cancer cells, notably liver cancer. It comprises gemcitabine as the payload and an aptamer that selectively binds to GPC3 protein. Gemcitabine, a proven systemic anticancer agent, is widely utilized in treating various cancers, including ovarian, breast, non-small cell lung, and pancreatic cancer. The choice of gemcitabine as the payload was deliberate, owing to its moderate toxicity profile, particularly suitable for liver targeting, given the organ's susceptibility to drug toxicity. Additionally, gemcitabine's nature as a DNA analogue facilitates its synthesis within the aptamer DNA sequence. The company's strategic focus on liver cancer addresses significant unmet medical needs, as evidenced by AST-201's superior efficacy over sorafenib in animal models and its synergistic effect when co-administered with anti-PD-1 therapy.
AST-201ancer poses a significant health challenge, particularly in East Asia, with a dismal survival rate. While combiGPC3 proteinpies such as atezolizumab and bevacizumab have emergcancerstandard treatmeliver cancernced liver cancgemcitabinefindings published in Nature Medicine suggest their limitGPC3 proteininGemcitabinever cancer populations with high GPC3 expression levels, highlighting substancancersmet medical needs. In this context, AST-201 offers a promising therapeutic approach by gemcitabiney targeting GPC3.gemcitabineliver cancerAST-201sorafenibPD-1
Liver cancerphase 1 trial seeks to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of AST-201 in patients with GPC3-posiatezolizumabd solbevacizumabNotably, Dr. Hong Jae Chon from CHA Bundaadvanced liver cancerprominent medical oncologist in South Korea, will serve as the coordinating investigator.liver cancerill be conducted acrossGPC3r hospitals, including CHA Bundang Medical Center, Samsung Medical Center, SeverancAST-201tal, and the National Cancer Center in South Korea.GPC3
Dr. Chon remarked, "GPC3 has garnered considerable attention in liver cancer therapeutic development among biAST-201ceutical companiesGPC3-positive advanced solid tumorsGPC3-positive optimism that "AST-201 may emerge as a novel treatment CHA Bundang Medical Centertients."CHA Bundang Medical CenterSeverance HospitalNational Cancer CenterCancer
Aptamer Sciences IncGPC3ms to showcase the clinical benefits of liver cancerthe technological value of its ApDCTM platform through this trial. Moreover, the companAST-201ipates that this milestone will propel its rliver cancerdevelopment efforts, enhancing the competitiveness of its subsequent hemato-oncology pipeline products, including AST-202 targeting CD25, ApRC (Aptamer Radioligand Conjugate), ApIS (Aptamer Immune Stimulator Conjugate), and so on.
Aptamer Sciences Inc.of Aptamer Sciences Inc., emphasized, "SincAST-201econd aptamer drug Izervay approved by FDA last year, aptamer technology has garnered significant attention in the pharmaceutical market," highlighting, "The AST-201 clinical trial will showcase the technological capabilities of the ApDCTM platform and expedite ongoingAST-202logy transfCD25iscussion with multiple partners. This milestone underscores Aptamer Sciences Inc.'s commitment to advancing innovative therapies and addressing critical unmet needs in oncology."
Fig 1. AST-201 structureAptamer Sciences Inc.of GPC3 aptamer, the payload of gemcitabine iIzervaygated as the FDAt of sequence.)AST-201Aptamer Sciences Inc.
Fig 2. AST-201 mechanism of actionGPC3 aptamerGPC3gemcitabine
1. AST-AST-201gets and binds to the GPC3 protein located on the surface of cancer cells.
2. AST-201g undergoes internalizatioGPC3 proteinancer cell by endocytosis.cancer
3. After the lysosomal degradation, gemcitabinecancerhosphate (dFdCMP), the active form of gemcitabine, is released within the cell leading to programmed cell death of the tumor cell (apoptosis).
About Aptamer Sciences, Inc.gemcitabinetumor
AptameAptamer Sciences, Inc.d on KOSDAQ in South Korea, is a global leading company in aptamer field. The company has established an integrated aptamer technology platform, called ApDCTM (Aptamer Drug Conjugate) and focused on developing oncology pipelines.
Aptamer Sciences Inc. please visit the website, www.aptsci.com/en or contact [email protected].
SOURCE Aptamer Sciences Inc.
更多内容,请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路,让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台,助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台,以API或者数据包形式对外开放,助您更加充分利用智慧芽新药情报信息。