Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate
Innovent Biologics has entered into an exclusive global license agreement with Roche for IBI3009, a novel DLL3-targeted antibody drug conjugate (ADC) candidate for treating advanced small cell lung cancer. IBI3009 has received IND approvals in Australia, China, and the U.S., with Phase 1 study initiation in December 2024.
IBI3009 targets DLL3, an antigen overexpressed in small-cell lung cancer and neuroendocrine tumors but with low expression in normal tissues. Developed using Innovent's proprietary topoisomerase 1 inhibitor platform, the drug has demonstrated promising anti-tumor activity in mouse models, particularly in chemo-resistant tumors.
Under the agreement, Roche gains exclusive global rights for development, manufacturing, and commercialization. Innovent will receive an $80 million upfront payment and is eligible for up to $1 billion in milestone payments plus tiered royalties on net sales.
Innovent Biologics ha stipulato un accordo di licenza globale esclusivo con Roche per IBI3009, un nuovo candidato farmaco congiunto anticorpo-farmaco (ADC) mirato a DLL3 per il trattamento del cancro polmonare a piccole cellule avanzato. IBI3009 ha ottenuto approvazioni IND in Australia, Cina e Stati Uniti, con l'inizio dello studio di Fase 1 previsto per dicembre 2024.
IBI3009 prende di mira DLL3, un antigene sovraespresso nel cancro polmonare a piccole cellule e nei tumori neuroendocrini, ma con bassa espressione nei tessuti normali. Sviluppato utilizzando la piattaforma inibitrice della topoisomerasi 1 proprietaria di Innovent, il farmaco ha dimostrato una promettente attività antitumorale in modelli murini, in particolare nei tumori resistenti alla chemioterapia.
Ai sensi dell'accordo, Roche ottiene diritti globali esclusivi per lo sviluppo, la produzione e la commercializzazione. Innovent riceverà un pagamento iniziale di 80 milioni di dollari e potrà ricevere fino a 1 miliardo di dollari in pagamenti legati a obiettivi, oltre a diritti su vendite nette.
Innovent Biologics ha firmado un acuerdo de licencia global exclusivo con Roche para IBI3009, un candidato de conjugado de fármaco anticuerpo (ADC) dirigido a DLL3 para el tratamiento del cáncer de pulmón de células pequeñas avanzado. IBI3009 ha recibido aprobaciones IND en Australia, China y EE. UU., con el inicio del estudio de Fase 1 previsto para diciembre de 2024.
IBI3009 tiene como objetivo DLL3, un antígeno sobreexpresado en el cáncer de pulmón de células pequeñas y en tumores neuroendocrinos, pero con baja expresión en tejidos normales. Desarrollado utilizando la plataforma de inhibidores de la topoisomerasa 1 de Innovent, el fármaco ha mostrado una prometedora actividad antitumoral en modelos de ratón, particularmente en tumores quimiorresistentes.
Bajo el acuerdo, Roche obtiene derechos globales exclusivos para el desarrollo, fabricación y comercialización. Innovent recibirá un pago inicial de 80 millones de dólares y será elegible para recibir hasta 1 mil millones de dólares en pagos por hitos, además de regalías escalonadas sobre las ventas netas.
Innovent Biologics는 로슈와 함께 고급 소세포 폐암 치료를 위한 새로운 DLL3 표적 항체 약물 접합체(ADC) 후보물질인 IBI3009에 대한 전세계 독점 라이센스 계약을 체결했습니다. IBI3009는 호주, 중국, 미국에서 IND 승인을 받았으며, 2024년 12월에 1상 연구가 시작될 예정입니다.
IBI3009는 소세포 폐암과 신경내분비 종양에서 과발현되는 항원인 DLL3을 표적으로 하며, 정상 조직에서의 발현은 낮습니다. Innovent의 독점 토포이소머라제 1 억제제 플랫폼을 사용하여 개발된 이 약물은 특히 화학요법 저항성 종양에서 마우스 모델에서 유망한 항종양 활성을 보여주었습니다.
계약에 따라 로슈는 개발, 제조 및 상업화에 대한 독점 글로벌 권리를 얻게 됩니다. Innovent는 8000만 달러의 선불 지급을 받고, 최대 10억 달러의 이정표 지급 및 순 매출에 대한 단계별 로열티를 받을 자격이 있습니다.
Innovent Biologics a conclu un accord de licence exclusif mondial avec Roche pour IBI3009, un nouvel anticorps conjugé ciblant DLL3 pour le traitement du cancer du poumon à petites cellules avancé. IBI3009 a obtenu des approbations IND en Australie, en Chine et aux États-Unis, avec le début de l'étude de Phase 1 prévu pour décembre 2024.
IBI3009 cible DLL3, un antigène surexprimé dans les cancers du poumon à petites cellules et les tumeurs neuroendocrines, mais avec une faible expression dans les tissus normaux. Développé en utilisant la plateforme d'inhibiteurs de la topoisomérase 1 d'Innovent, le médicament a montré une activité antitumorale prometteuse dans des modèles murins, en particulier dans les tumeurs résistantes à la chimiothérapie.
En vertu de l'accord, Roche obtient des droits exclusifs mondiaux pour le développement, la fabrication et la commercialisation. Innovent recevra un paiement initial de 80 millions de dollars et pourra recevoir jusqu'à 1 milliard de dollars en paiements d'étape plus des redevances échelonnées sur les ventes nettes.
Innovent Biologics hat einen exklusiven globalen Lizenzvertrag mit Roche für IBI3009, einen neuartigen DLL3-zielgerichteten Antikörper-Wirkstoff-Konjugat (ADC) Kandidaten zur Behandlung von fortgeschrittenem kleinzelligem Lungenkrebs, abgeschlossen. IBI3009 hat in Australien, China und den USA IND-Zulassungen erhalten, mit dem Beginn der Phase 1-Studie im Dezember 2024.
IBI3009 zielt auf DLL3 ab, ein Antigen, das in kleinzelligem Lungenkrebs und neuroendokrinen Tumoren überexprimiert ist, jedoch eine geringe Expression in normalem Gewebe aufweist. Das Medikament wurde unter Verwendung der proprietären Topoisomerase-1-Inhibitor-Plattform von Innovent entwickelt und hat vielversprechende antitumorale Aktivitäten in Mausmodellen gezeigt, insbesondere bei chemoresistenten Tumoren.
Im Rahmen des Vertrags erhält Roche exklusive globale Rechte für Entwicklung, Herstellung und Vermarktung. Innovent wird eine Vorabzahlung von 80 Millionen US-Dollar erhalten und hat Anspruch auf bis zu 1 Milliarde US-Dollar an Meilensteinzahlungen sowie gestaffelte Lizenzgebühren auf Nettoumsätze.
- Secured $80 million upfront payment from Roche
- Potential to receive up to $1 billion in milestone payments plus royalties
- IBI3009 has obtained IND approvals in three major markets (US, China, Australia)
- Partnership with global pharmaceutical leader Roche enhances development capabilities
- Early-stage development status (Phase 1) indicates long pathway to commercialization
- Development and commercialization control transferred to Roche
IBI3009: A potentially best-in-class DLL3 ADC Candidate
IBI3009 targets DLL3, an antigen with low expression in normal tissues but significantly overexpressed in certain cancers, particularly small-cell lung cancer and other neuroendocrine tumors. Developed leveraging Innovent's proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform, IBI3009 is one of the leading and potentially best-in-class DLL3-targeting ADCs. IBI3009 has shown encouraging anti-tumor activity in multiple tumor-bearing mouse models, particularly in chemo-resistant tumor types, and has demonstrated a favorable safety profile.
Dr. Samuel Zhang, Chief Business Officer of Innovent, stated: "We are delighted to once again enter a strategic collaboration with Roche, a global leader in oncology, to advance our potentially best-in-class DLL3 ADC candidate. By combining Roche's scientific expertise and global development capabilities with our innovative approach, we are taking a significant step forward in our mission—to empower patients worldwide with affordable, high-quality biopharmaceuticals."
"We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer. This partnership builds on Roche's long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumors with transformational medicines," said Boris L. Zaïtra, Head of Corporate Business Development at Roche.
Under the agreement, Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009. The two parties will jointly focus on the early-stage development of this ADC candidate, after which Roche will take over full development. Innovent will receive an upfront payment of
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Innovent's Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
View original content:https://www.prnewswire.com/news-releases/innovent-enters-into-exclusive-global-license-agreement-with-roche-for-novel-dll3-antibody-drug-conjugate-302340668.html
SOURCE Innovent Biologics
FAQ
What are the financial terms of Innovent's DLL3 ADC agreement with Roche?
What is the current development stage of IBI3009?
What type of cancer does IBI3009 target?
What rights does Roche receive under the agreement?
What technology platform is IBI3009 based on?
