Innovent Announces First Patient Dosed in Phase 1 Study of IBI3020, Global First-in-class Dual Payload CEACAM5 ADC, in Patients with Advanced Malignancies
Innovent Biologics has achieved a significant milestone with the first patient dosing of IBI3020, a groundbreaking dual-payload CEACAM5 ADC, in a Phase 1 clinical trial for advanced solid tumors. This marks a global first-in-class development in cancer treatment technology.
The multi-regional Phase 1 study, approved in both China and the U.S., will evaluate the safety, tolerability, and preliminary efficacy of IBI3020. The drug, developed from Innovent's proprietary DuetTx® dual-payload ADC platform, works by selectively binding to CEACAM5-expressing tumor cells and releasing two types of cytotoxic payloads to kill cancer cells.
Preclinical studies have shown promising results, with IBI3020 demonstrating strong antitumor activity and manageable safety profiles. The drug targets CEACAM5, a protein overexpressed in various solid tumors including colorectal cancer, non-squamous lung cancer, gastric cancer, and pancreatic cancer, while showing limited expression in healthy tissues.
Innovent Biologics ha raggiunto un traguardo importante con la somministrazione al primo paziente di IBI3020, un innovativo ADC a doppio carico CEACAM5, in uno studio clinico di Fase 1 per tumori solidi avanzati. Questo rappresenta una prima mondiale nel campo della tecnologia per il trattamento del cancro.
Lo studio multi-regionale di Fase 1, approvato sia in Cina che negli Stati Uniti, valuterà la sicurezza, la tollerabilità e l'efficacia preliminare di IBI3020. Il farmaco, sviluppato sulla base della piattaforma proprietaria DuetTx® dual-payload ADC di Innovent, agisce legandosi selettivamente alle cellule tumorali che esprimono CEACAM5 e rilasciando due tipi di carichi citotossici per eliminare le cellule cancerose.
Gli studi preclinici hanno mostrato risultati promettenti, con IBI3020 che ha dimostrato una forte attività antitumorale e un profilo di sicurezza gestibile. Il farmaco mira a CEACAM5, una proteina sovraespressa in diversi tumori solidi tra cui cancro del colon-retto, carcinoma polmonare non a piccole cellule, cancro gastrico e pancreatico, mostrando un'espressione limitata nei tessuti sani.
Innovent Biologics ha alcanzado un hito significativo con la administración al primer paciente de IBI3020, un innovador ADC de doble carga CEACAM5, en un ensayo clínico de Fase 1 para tumores sólidos avanzados. Esto representa un desarrollo pionero a nivel mundial en la tecnología para el tratamiento del cáncer.
El estudio multinacional de Fase 1, aprobado tanto en China como en EE.UU., evaluará la seguridad, tolerabilidad y eficacia preliminar de IBI3020. El fármaco, desarrollado a partir de la plataforma propia DuetTx® dual-payload ADC de Innovent, actúa uniéndose selectivamente a las células tumorales que expresan CEACAM5 y liberando dos tipos de cargas citotóxicas para eliminar las células cancerosas.
Los estudios preclínicos han mostrado resultados prometedores, con IBI3020 demostrando una fuerte actividad antitumoral y un perfil de seguridad manejable. El fármaco se dirige a CEACAM5, una proteína sobreexpresada en varios tumores sólidos como cáncer colorrectal, cáncer de pulmón no escamoso, cáncer gástrico y pancreático, mostrando una expresión limitada en tejidos sanos.
Innovent Biologics는 진행성 고형암을 대상으로 한 1상 임상시험에서 혁신적인 이중 탑재 CEACAM5 ADC인 IBI3020의 첫 환자 투여라는 중요한 이정표를 달성했습니다. 이는 암 치료 기술 분야에서 세계 최초의 혁신적인 개발입니다.
중국과 미국에서 승인된 다지역 1상 연구는 IBI3020의 안전성, 내약성 및 초기 효능을 평가할 예정입니다. Innovent의 독자적인 DuetTx® 이중 탑재 ADC 플랫폼에서 개발된 이 약물은 CEACAM5를 발현하는 종양 세포에 선택적으로 결합하여 두 종류의 세포독성 탑재체를 방출해 암 세포를 사멸시킵니다.
전임상 연구 결과 IBI3020은 강력한 항종양 활성을 보였으며 관리 가능한 안전성 프로파일을 나타냈습니다. 이 약물은 대장암, 비편평세포 폐암, 위암, 췌장암 등 다양한 고형암에서 과발현되는 단백질인 CEACAM5를 표적으로 하며, 정상 조직에서는 제한적으로 발현됩니다.
Innovent Biologics a franchi une étape importante avec la première administration à un patient de IBI3020, un ADC innovant à double charge CEACAM5, dans un essai clinique de phase 1 pour les tumeurs solides avancées. Cela représente une première mondiale dans la technologie de traitement du cancer.
Cette étude de phase 1 multirégionale, approuvée en Chine et aux États-Unis, évaluera la sécurité, la tolérance et l'efficacité préliminaire de IBI3020. Le médicament, développé à partir de la plateforme propriétaire DuetTx® dual-payload ADC d'Innovent, agit en se liant sélectivement aux cellules tumorales exprimant CEACAM5 et en libérant deux types de charges cytotoxiques pour éliminer les cellules cancéreuses.
Les études précliniques ont montré des résultats prometteurs, avec IBI3020 démontrant une forte activité antitumorale et un profil de sécurité gérable. Le médicament cible CEACAM5, une protéine surexprimée dans plusieurs tumeurs solides telles que le cancer colorectal, le cancer du poumon non à petites cellules, le cancer gastrique et le cancer du pancréas, tout en présentant une expression limitée dans les tissus sains.
Innovent Biologics hat einen bedeutenden Meilenstein erreicht: Die erste Patientendosierung von IBI3020, einem bahnbrechenden CEACAM5-ADC mit doppelter Nutzlast, in einer Phase-1-Studie bei fortgeschrittenen soliden Tumoren. Dies markiert eine weltweit erstmalige Entwicklung in der Krebstherapietechnologie.
Die multiregionale Phase-1-Studie, die sowohl in China als auch in den USA genehmigt wurde, wird die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von IBI3020 bewerten. Das Medikament, entwickelt auf Basis der firmeneigenen DuetTx® Dual-Payload-ADC-Plattform von Innovent, wirkt, indem es selektiv an CEACAM5-exprimierende Tumorzellen bindet und zwei Arten von zytotoxischen Nutzlasten freisetzt, um Krebszellen abzutöten.
Präklinische Studien zeigten vielversprechende Ergebnisse, wobei IBI3020 starke antitumorale Aktivität und ein beherrschbares Sicherheitsprofil aufwies. Das Medikament zielt auf CEACAM5 ab, ein Protein, das in verschiedenen soliden Tumoren wie kolorektalem Krebs, nicht-plattenepithelialem Lungenkrebs, Magen- und Bauchspeicheldrüsenkrebs überexprimiert wird und in gesunden Geweben nur begrenzt vorkommt.
- First-in-class dual-payload CEACAM5 ADC entering clinical trials, demonstrating innovation leadership
- Successful IND approval in both US and China markets, expanding global reach
- Robust preclinical results showing strong antitumor activity across various models
- Proprietary DuetTx® platform technology with independent intellectual property rights
- Strategic advancement in 'IO+ADC' portfolio with potential market differentiation
- Early Phase 1 stage with no proven clinical efficacy yet
- Significant R&D expenses expected during clinical trials
- Competitive market with existing cancer treatments
- Long pathway to potential commercialization with no guaranteed success
The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced solid tumors, as well as determining the recommended Phase 2 dose (RP2D). The study has received IND approval in the
As a global first-in-class ADC candidate, IBI3020 is generated from Innovent's proprietary DuetTx® dual-payload ADC platform. The internationalization of the CEACAM5-dependent ADC occurs after IBI3020 selectively binds to CEACAM5-expressing tumor cells, followed by lysosomal degradation. This process releases two types of cytotoxic payloads, leading to cell killing of tumor cells.
In preclinical studies, IBI3020 has demonstrated robust antitumor activity across various tumor-bearing pharmacology models, with a notable bystander killing effect. Additionally, IBI3020 has shown favorable safety characteristics in preclinical models, with an overall manageable safety profile.
Professor Yu Jinming, Shandong Cancer Hospital, stated:" Carcinoembryonic antigen (CEA), also known as CEACAM5, is a glycosylphosphatidylinositol-anchored cell-surface glycoprotein involved in cell adhesion, invasion, and metastasis of cancer cells. There is a significant clinical need for effective therapies in advanced colorectal cancer, non-squamous lung cancer, gastric cancer, pancreatic cancer, and others. CEACAM5 is overexpressed in these solid tumors but shows limited expression in healthy tissues, making it a potentially safe and promising therapeutic target. The dual payload of IBI3020 consists of two types of payloads that have been clinically validated. This dual-payload design has demonstrated enhanced tumor-killing effects in preclinical studies. We look forward to observing the clinical profiles and potential breakthrough of IBI3020 in terms of safety, tolerability, and efficacy in clinical trials."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to announce the successful dosing of the first patient dose with IBI3020. We will continue to advance the global development of IBI3020, aiming to offer better treatment options for patients with advanced solid tumors. Innovent possesses innovative ADC technology platforms with independent intellectual property rights. Multiple ADC molecules have clinically validated their differentiated competitiveness. IBI3020, Innovent's first dual-payload ADC, has successfully entered clinical trials and is the first dual-payload ADC globally known in the same class to complete the first-in-human dosing, marking a breakthrough in Innovent's ADC technology. We will continue our "IO+ADC" strategy, focusing on next-generation innovations with global potential to benefit cancer patients worldwide."
About IBI3020
IBI3020 is a global first-in-class ADC candidate developed from Innovent's proprietary DuetTx® dual-payload ADC platform. The CEACAM5 dependent ADC internalization occurs after IBI3020 selectively binds to the CEACAM5-expressing tumor cells, followed by the lysosomal degradation. This process releases two types of cytotoxic payloads, leading to tumor cell killing.
The multi-regional Phase 1 study of IBI3020, initiated in China, assesses the safety, tolerability, and preliminary efficacy of IBI3020 in patients with advanced solid tumors and aims to determine the recommended Phase 2 dose (RP2D). The study has also received IND approval in the
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 15 products in the market. It has 3 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 16 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.
Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
(2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. |
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