Ipsen and Sutro Biopharma Announce Exclusive Global Licensing Agreement for an ADC Targeting Solid Tumors
Ipsen and Sutro Biopharma Announce Exclusive Global Licensing Agreement for an ADC Targeting Solid Tumors
Ipsen secures exclusive global rights for development and commercialization of STRO-003, an antibody-drug conjugate, completing the final stages of pre-clinical development
STRO-003 targets ROR1, a clinically validated antibody drug conjugate (ADC) target
STRO-003 has shown robust monotherapy efficacy and potential for a differentiated safety profile in preclinical development in solid tumors and hematological malignancies1
益普生获得抗体药物偶联物 STRO-003 的全球独家开发和商业化权，完成了临床前开发的最后阶段
STRO-003 靶向经临床验证的抗体药物偶联物 (ADC) 靶标 ROR1
STRO-003 在实体瘤和血液系统恶性肿瘤的临床前开发中显示出强大的单一疗法疗效和差异化安全性的潜力1
PARIS, FRANCE; SAN FRANCISCO, U.S., 02 April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Sutro Biopharma (NASDAQ: STRO, "Sutro", "the Company") today announced an exclusive global licensing agreement for STRO-003. STRO-003, an antibody-drug conjugate (ADC) in the final stages of pre-clinical development, targets the ROR1 tumor antigen which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies.1 The agreement gives Ipsen exclusive worldwide rights to develop and commercialize STRO-003 and will be the first ADC candidate joining Ipsen's expanding portfolio.
法国巴黎；美国旧金山，2024年4月2日——益普生（泛欧交易所：IPN；ADR：IPSEY）和苏创生物制药（纳斯达克股票代码：STRO，“Sutro”，“公司”）今天宣布了 STRO-003 的独家全球许可协议。STRO-003 是一种处于临床前开发最后阶段的抗体药物偶联物 (ADC)，靶向 ROR1 肿瘤抗原，众所周知，该抗原在许多不同的癌症类型中过度表达，包括实体瘤和血液系统恶性肿瘤。1 该协议赋予了益普生开发和商业化 STRO-003 的全球独家权利，并将成为加入益普生不断扩大的产品组合的第一个 ADC 候选药物。
"The potential for ADCs in oncology is well-documented and we are excited by the addition of STRO-003, Ipsen's first ADC candidate with best-in-class potential." said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen. "STRO-003 is a next-generation ROR1 ADC, leveraging Sutro's site-specific technology to generate a highly stable conjugate, coupled with exatecan payloads, that have shown significant potential in solid tumors. This is our focus as we prepare to enter Phase I, harnessing Ipsen's global expertise in oncology development, while also reinforcing our commitment to bringing new medicines to patients with few treatment options."
益普生高级副总裁兼早期开发主管玛丽·简·欣里希斯表示：“ADC在肿瘤学中的潜力有据可查，我们对易普生首款具有同类最佳潜力的ADC候选药物的加入感到兴奋。” STRO-003“STRO-003 是下一代ROR1 ADC，它利用Sutro的位点特异性技术来生成高度稳定的偶联物，再加上exatecan有效载荷，在实体瘤中显示出巨大的潜力。这是我们准备进入第一阶段时的重点，利用益普生在肿瘤学开发方面的全球专业知识，同时也加强了我们为几乎没有治疗选择的患者提供新药的承诺。”
"We are excited to partner STRO-003 with Ipsen to help us reach more patients faster while retaining significant downstream participation in a medicine in which we believe," said Jane Chung, President and Chief Operating Officer at Sutro. "Sutro's research innovation represented in STRO-003 illustrates our leadership in ADC design. We look forward to collaborating with Ipsen's impressive oncology development team to bring a differentiated ROR1-targeted ADC to patients."
Sutro总裁兼首席运营官Jane Chung表示：“我们很高兴能与益普生合作 STRO-003，帮助我们更快地接触到更多患者，同时保持下游对我们所信赖的药物的大量参与。”“STRO-003 中体现的 Sutro 的研究创新体现了我们在 ADC 设计方面的领导地位。我们期待与Ipsen令人印象深刻的肿瘤学开发团队合作，为患者带来差异化的ROR1靶向ADC。”
ADCs are comprised of three main components: the antibody, payload and linker. The antibody selectively targets an identified tumor antigen, such as ROR1. 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.2
ADC 由三个主要成分组成：抗体、有效载荷和连接物。该抗体选择性地靶向已确定的肿瘤抗原，例如ROR1。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。连接器连接抗体和有效载荷，减少到达非肿瘤组织的有效载荷量。2
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 activities and global commercialization activities. Sutro Biopharma is eligible to receive up to $900m in potential upfront, development, regulatory and commercial milestone payments including approximately $90m in near-term payments, including an equity investment, and tiered royalties on global sales, contingent upon successful development and commercialization.
根据协议条款，益普生将负责第一阶段的准备活动，包括提交研究性新药（IND）申请，以及所有后续的临床开发活动和全球商业化活动。Sutro Biopharma有资格获得高达9亿美元的潜在预付款、开发、监管和商业里程碑款项，包括约9000万美元的近期付款，包括股权投资和全球销售的分级特许权使用费，前提是成功开发和商业化。
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References
参考文献
1 Preclinical development of STRO-003, a ROR1 targeted antibody-drug conjugate. 14th Annual WADS ADC. San Diego 2023. Available here:
2 E. Jabbour, S. Paul, H. Kantarjian. The clinical development of antibody-drug conjugates – lessons from leukemia. Nature Reviews Clinical Onoclogy. 2021. 18: 418-433.
1 ROR1 靶向抗体药物偶联物 STRO-003 的临床前开发。第 14 届年度 WADS ADC。2023 年圣地亚哥。可在此处获得：
2 E. Jabbour、S. Paul、H. Kantarjian。抗体药物偶联物的临床开发——白血病的教训。《自然评论》临床肿瘤学。2021. 18：418-433。