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
益普生獲得抗體藥物偶聯物 STRO-003 的全球獨家開發和商業化權，完成了臨床前開發的最後階段
STRO-003 靶向經臨床驗證的抗體藥物偶聯物 (ADC) 靶標 ROR1
STRO-003 在實體瘤和血液系統惡性腫瘤的臨床前開發中顯示出強大的單一療法療效和差異化安全性的潛力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.
法國巴黎；美國舊金山，2024年4月2日——益普生（泛歐交易所：IPN；ADR：IPSEY）和蘇創生物製藥（納斯達克股票代碼：STRO，“Sutro”，“公司”）今天宣佈了 STRO-003 的獨家全球許可協議。STRO-003 是一種處於臨床前開發最後階段的抗體藥物偶聯物 (ADC)，靶向 ROR1 腫瘤抗原，衆所周知，該抗原在許多不同的癌症類型中過度表達，包括實體瘤和血液系統惡性腫瘤。1 該協議賦予了益普生開發和商業化 STRO-003 的全球獨家權利，並將成爲加入益普生不斷擴大的產品組合的第一個 ADC 候選藥物。
"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."
益普生高級副總裁兼早期開發主管瑪麗·簡·欣裏希斯表示：“ADC在腫瘤學中的潛力有據可查，我們對易普生首款具有同類最佳潛力的ADC候選藥物的加入感到興奮。” STRO-003“STRO-003 是下一代ROR1 ADC，它利用Sutro的位點特異性技術來生成高度穩定的偶聯物，再加上exatecan有效載荷，在實體瘤中顯示出巨大的潛力。這是我們準備進入第一階段時的重點，利用益普生在腫瘤學開發方面的全球專業知識，同時也加強了我們爲幾乎沒有治療選擇的患者提供新藥的承諾。”
"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總裁兼首席運營官Jane Chung表示：“我們很高興能與益普生合作 STRO-003，幫助我們更快地接觸到更多患者，同時保持下游對我們所信賴的藥物的大量參與。”“STRO-003 中體現的 Sutro 的研究創新體現了我們在 ADC 設計方面的領導地位。我們期待與Ipsen令人印象深刻的腫瘤學開發團隊合作，爲患者帶來差異化的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 由三個主要成分組成：抗體、有效載荷和連接物。該抗體選擇性地靶向已確定的腫瘤抗原，例如ROR1。有效載荷是治療癌症的藥物活性成分，通過化學連接劑附着在抗體上。連接器連接抗體和有效載荷，減少到達非腫瘤組織的有效載荷量。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.
根據協議條款，益普生將負責第一階段的準備活動，包括提交研究性新藥（IND）申請，以及所有後續的臨床開發活動和全球商業化活動。Sutro Biopharma有資格獲得高達9億美元的潛在預付款、開發、監管和商業里程碑款項，包括約9000萬美元的近期付款，包括股權投資和全球銷售的分級特許權使用費，前提是成功開發和商業化。
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References
參考文獻
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 靶向抗體藥物偶聯物 STRO-003 的臨床前開發。第 14 屆年度 WADS ADC。2023 年聖地亞哥。可在此處獲得：
2 E. Jabbour、S. Paul、H. Kantarjian。抗體藥物偶聯物的臨床開發——白血病的教訓。《自然評論》臨床腫瘤學。2021. 18：418-433。