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Centessa Pharmaceuticals Announces FDA Clearance Of IND Application For Phase 1/2a Clinical Trial Of LB101, First LockBody Candidate, For Solid Tumors
Centessa Pharmaceuticals Announces FDA Clearance Of IND Application For Phase 1/2a Clinical Trial Of LB101, First LockBody Candidate, For Solid Tumors
Centessa Pharmaceuticals plc (NASDAQ:CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors. LB101, a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company's proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity.
"We are very excited to be bringing our first LockBody candidate to the clinic and to be advancing a potentially transformative technology for patients with solid tumors," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "The clearance of our IND for LB101 is an important milestone for our company as we have an ambitious strategy to advance multiple potential LockBody candidates in areas where there is a significant need for new cancer treatment options. We look forward to initiating the Phase 1/2a trial of LB101 as soon as possible."
About LB101
LB101 is a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor.
Centessa Pharmaceuticals plc (NASDAQ:CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors. LB101, a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company's proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity.
致力于发现和开发对患者具有变革作用的药物的临床阶段制药公司Centessa PharmPharmticals Plc(纳斯达克代码:CNTA)今天宣布,它已获得美国食品和药物管理局(FDA)的批准,将启动LB101治疗实体肿瘤的1/2a期首个人类临床试验。LB101是一种针对实体肿瘤的有条件的四价PD-L1xCD47 LockBody双特异性单抗,是使用该公司的LockBody专利技术开发的第一个候选产品,该技术旨在选择性地在肿瘤微环境(TME)中驱动潜在的效应器功能活动,如CD47,同时避免全身毒性。
"We are very excited to be bringing our first LockBody candidate to the clinic and to be advancing a potentially transformative technology for patients with solid tumors," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "The clearance of our IND for LB101 is an important milestone for our company as we have an ambitious strategy to advance multiple potential LockBody candidates in areas where there is a significant need for new cancer treatment options. We look forward to initiating the Phase 1/2a trial of LB101 as soon as possible."
Centessa公司首席执行官Saurabh Saha医学博士说:“我们非常高兴能将我们的第一个LockBody候选产品带到临床,并为实体肿瘤患者推进一项潜在的变革性技术。批准我们的IND用于LB101对我们公司来说是一个重要的里程碑,因为我们有一个雄心勃勃的战略,在对新的癌症治疗方案有重大需求的地区推进多个潜在的LockBody候选者。我们期待着尽快启动LB101的1/2a阶段试验。“
About LB101
LB101 is a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor.
关于LB101
LB101是一种条件性四价PD-L1xCD47 LockBody双特异性单抗,具有两个被两个抗PD-L1结构域阻断的抗CD47结构域,以及连接抗CD47和抗PD-L1结构域的专有人免疫球蛋白衍生铰链。杀伤细胞的作用机制CD47被设计为被PD-L1肿瘤靶向域阻断,直到免疫球蛋白衍生的铰链在TME中自然降解,从而解锁和激活肿瘤中的CD47效应器功能活性。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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