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PARIS, FRANCE, 11 July 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology (Foreseen) today announced an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential. FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis.
2024年7月11日,法国巴黎–昱言公司(Foreseen)和益普生(Euronext: IPN;ADR: IPSEY)今天宣布了FS001的独家全球许可协议。FS001是一种具有首创新药(FIC)潜力的抗体-药物偶联物(ADC),靶向一种全新的肿瘤相关抗原,该抗原在许多实体肿瘤中过表达,并在肿瘤增殖和转移中起关键作用。
This novel tumor antigen was identified using Foreseen’s high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms, to analyze their vast collection of well-characterized clinical tumor samples. FS001 utilized an innovative, stable and cleavable linker coupled to a potent topoisomerase I inhibitor. Preclinical efficacy of FS001 was demonstrated in multi-drug resistant cancer models. The agreement gives Ipsen exclusive worldwide rights to develop, manufacture and commercialize FS001.
这种新型肿瘤抗原是由昱言公司专属的高通量、整合性转化蛋白质组学和人工智能(AI)驱动的筛选平台,通过分析所收集到的大量具有明确特征的临床肿瘤样本开发而成。FS001利用了一种创新的、稳定的、可切割的连接体,与一种非常有效的拓扑异构酶I抑制剂偶联。FS001在多种耐药癌症模型中也显示了良好的临床前疗效。该协议赋予益普生在全球范围内开发、制造和商业化FS001的独家权利。
“We are excited to add FS001, the second ADC Ipsen has in-licensed this year, to our growing pipeline. Using cutting-edge proteomics technology and AI-powered screening platforms the Foreseen team has uncovered a novel and clinically relevant target which could unlock the potential of ADCs for even more people living with hard-to-treat forms of cancer,” said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen. “As we prepare for the initiation of a Phase I clinical trial, we will evaluate FS001 in selected solid tumor types, which we hope will deliver critical new treatments for people living with cancer around the world.”
“我们很高兴将 FS001 添加到我们不断增长的产品线中,这是益普生今年获得授权的第⼆个 ADC。通过使用尖端的蛋白质组学技术和人工智能筛选平台,昱言团队发现了⼀个全新的治疗相关靶点,进⼀步释放 ADC 的潜力,治疗更多的患有难治性癌症的患者。” 益普生高级副总裁兼早期开发主管 Mary Jane Hinrichs 表示:“随着我们准备启动 I 期临床试验,我们将在选定的实体肿瘤类型中评估 FS001,我们希望这将为世界各地的癌症患者提供关键的新疗法。”
“Our strategic partnership with Ipsen provides a strong endorsement to our high throughput integrated translational proteomics platform approach to discover and develop innovative therapeutic products with first-in-class potential”, said Catherine Wong, Founder and Chairman of Foreseen. “We are pleased to be collaborating with Ipsen to advance FS001 globally, harnessing Ipsen’s robust track record in accelerating the clinical development and commercialization of innovative therapeutics. We believe FS001 has the potential to treat multiple cancers as a single agent or in combination with standard of care.”
“我们与益普生的战略合作伙伴关系为我们用高通量、整合性转化蛋白质组学平台,发现和开发具有完全创新的治疗产品的方法流程,提供了强有力的认可,” 昱言公司的创始人兼董事长Catherine Wong(黄超兰)说。“我们很高兴与益普生合作,在全球范围内推进 FS001。益普生在加速创新疗法的临床开发和商业化方面有着良好的记录。我们相信 FS001 有潜力作为单⼀药物或与标准治疗联用治疗多种癌症。”
Foreseen Biotechnology is eligible to receive up to $1.03bn comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on global sales, contingent upon successful development and regulatory approvals. Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development, manufacturing, and global commercialization activities.
通过此次交易,昱言公司将获得高达 10.3 亿美元的资金,包括首付款、开发、监管和商业化重要节点的付款,以及成功的开发和监管批准后的全球销售分级特许权使用费。根据协议条款,益普生将负责 I 期准备工作,包括提交新药临床试验 (IND) 申请以及所有后续临床开发、生产和全球商业化活动。
About Ipsen
关于益普生
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
我们是⼀家全球性的生物制药公司,专注于在肿瘤、罕见病和神经三个治疗领域为患者提供革新药物。
Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries.
我们的产品线以外部创新为动力,以近 100 年的开发经验和在美国、法国和英国的全球中心为支持。我们遍布在 40 多个国家的团队,和我们在世界各地的合作伙伴,使我们能够为80多个国家的患者提供药物。
Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.
益普生通过美国存托凭证计划 (ADR: IPSEY) 的⼀级赞助,在巴黎 (Euronext: IPN) 和美国上市。
About Foreseen Biotechnology
关于昱言
We are an emerging biotechnology company that pioneered a high throughput integrated translational proteomics platform powered by AI-based data analytical system to accelerate discovery of novel targets for therapeutics and diagnostics that are clinically relevant. We are building a pipeline of novel product candidates for the diagnosis and treatment of cancer, inflammatory/autoimmune diseases and neurological disorders.
我们是⼀家新兴的生物技术公司,开创了高通量、整合性转化蛋白质组学平台,由基于人工智能的数据分析系统支持,以加速发现临床相关治疗和诊断的全新靶点。我们正在建立用于诊断和治疗癌症、炎症/自身免疫性疾病和神经系统疾病的新候选产品管道。昱言由巢生公司孵化成立。
About Antibody-Drug Conjugates (ADCs)
关于抗体-药物偶联物(ADC)
ADCs are comprised of three main components: the antibody, a payload and a linker. The antibody selectively targets an identified tumor antigen. Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches non-tumor tissue.1.
ADC 由三个主要成分组成: 抗体、有效载荷和连接体。该抗体选择性地靶向已识别的肿瘤抗原。有效载荷是治疗癌症的药物活性成分,通过化学连接剂附着在抗体上。该连接体连接抗体和有效载荷,并减少到达非肿瘤组织的有效载荷的数量。
About FS001
关于FS001
FS001 is a potential first-in-class ADC with demonstrated preclinical efficacy in multiple solid tumors as well as a favorable safety profile with wide therapeutic window in animal studies. FS001 is comprised of (i) Foreseen’s proprietary antibody that specifically binds to a novel target identified using the company’s high throughput integrated translational proteomics platform and (ii) an innovative linker-payload with excellent pharmaceutical features developed by Shanghai Escugen Biotechnology Co. Ltd. FS001 is in the final stages of pre-clinical development.
FS001 是⼀种潜在的首创新药 ADC,在多种实体肿瘤中具有临床前疗效,并且在动物研究中具有良好的安全性和广泛的治疗窗口。FS001 由(i)昱言的专属抗体,靶向利用公司高通量整合转化蛋白质组学平台所鉴定的新靶点,和 (ii)上海诗健生物技术有限公司开发的,具有优异药物特性的创新连接体和有效载荷组成。FS001 正处于临床前开发的最后阶段。