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 attivit脿 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 ricever脿 un pagamento iniziale di 80 milioni di dollari e potr脿 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 f谩rmaco anticuerpo (ADC) dirigido a DLL3 para el tratamiento del c谩ncer de pulm贸n de c茅lulas peque帽as 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 ant铆geno sobreexpresado en el c谩ncer de pulm贸n de c茅lulas peque帽as y en tumores neuroendocrinos, pero con baja expresi贸n en tejidos normales. Desarrollado utilizando la plataforma de inhibidores de la topoisomerasa 1 de Innovent, el f谩rmaco ha mostrado una prometedora actividad antitumoral en modelos de rat贸n, particularmente en tumores quimiorresistentes.
Bajo el acuerdo, Roche obtiene derechos globales exclusivos para el desarrollo, fabricaci贸n y comercializaci贸n. Innovent recibir谩 un pago inicial de 80 millones de d贸lares y ser谩 elegible para recibir hasta 1 mil millones de d贸lares en pagos por hitos, adem谩s de regal铆as escalonadas sobre las ventas netas.
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Innovent Biologics a conclu un accord de licence exclusif mondial avec Roche pour IBI3009, un nouvel anticorps conjug茅 ciblant DLL3 pour le traitement du cancer du poumon 脿 petites cellules avanc茅. IBI3009 a obtenu des approbations IND en Australie, en Chine et aux 脡tats-Unis, avec le d茅but de l'茅tude de Phase 1 pr茅vu pour d茅cembre 2024.
IBI3009 cible DLL3, un antig猫ne surexprim茅 dans les cancers du poumon 脿 petites cellules et les tumeurs neuroendocrines, mais avec une faible expression dans les tissus normaux. D茅velopp茅 en utilisant la plateforme d'inhibiteurs de la topoisom茅rase 1 d'Innovent, le m茅dicament a montr茅 une activit茅 antitumorale prometteuse dans des mod猫les murins, en particulier dans les tumeurs r茅sistantes 脿 la chimioth茅rapie.
En vertu de l'accord, Roche obtient des droits exclusifs mondiaux pour le d茅veloppement, la fabrication et la commercialisation. Innovent recevra un paiement initial de 80 millions de dollars et pourra recevoir jusqu'脿 1 milliard de dollars en paiements d'茅tape plus des redevances 茅chelonn茅es sur les ventes nettes.
Innovent Biologics hat einen exklusiven globalen Lizenzvertrag mit Roche f眉r IBI3009, einen neuartigen DLL3-zielgerichteten Antik枚rper-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 眉berexprimiert ist, jedoch eine geringe Expression in normalem Gewebe aufweist. Das Medikament wurde unter Verwendung der propriet盲ren Topoisomerase-1-Inhibitor-Plattform von Innovent entwickelt und hat vielversprechende antitumorale Aktivit盲ten in Mausmodellen gezeigt, insbesondere bei chemoresistenten Tumoren.
Im Rahmen des Vertrags erh盲lt Roche exklusive globale Rechte f眉r 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 Lizenzgeb眉hren auf Nettoums盲tze.
- 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听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听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:听"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鈥攖o 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. Za茂tra, 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 , or follow听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.
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