Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors
Innate Pharma announced FDA clearance of its IND application for IPH4502, a novel topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. The company plans to initiate a Phase 1 clinical study in the coming months. The study will be an open-label, multi-center trial assessing the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.
The study will include a Part 1 Dose Escalation and a Part 2 Dose Optimization. This marks Innate's first ADC program to enter clinical trials, representing a significant milestone for the company.
Innate Pharma ha annunciato l'approvazione da parte della FDA della sua domanda IND per IPH4502, un nuovo inibitore della topoisomerasi I conjugato farmaco-antibody (ADC) che colpisce Nectin-4 in tumori solidi. L'azienda prevede di avviare uno studio clinico di Fase 1 nei prossimi mesi. Lo studio sarà uno trial multicentrico in aperto che valuterà la sicurezza, la tollerabilità e l'efficacia preliminare di IPH4502 come agente singolo in tumori solidi avanzati noti per esprimere Nectin-4, inclusi carcinoma uroteliale, carcinoma polmonare non a piccole cellule, mammella, ovaio, gastrico e colon-retto.
Lo studio includerà una Parte 1 di Escalation della Dose e una Parte 2 di Ottimizzazione della Dose. Questo segna il primo programma ADC di Innate ad entrare negli studi clinici, rappresentando una pietra miliare significativa per l'azienda.
Innate Pharma anunció la aprobación de la FDA para su solicitud IND de IPH4502, un novedoso conjugado de fármaco-antibodies (ADC) inhibidor de la topoisomerasa I que se dirige a Nectin-4 en tumores sólidos. La compañía planea iniciar un estudio clínico de Fase 1 en los próximos meses. El estudio será un ensayo multicéntrico abierto que evaluará la seguridad, tolerabilidad y eficacia preliminar de IPH4502 como agente único en tumores sólidos avanzados que se sabe que expresan Nectin-4, incluidos carcinoma urotelial, carcinoma de pulmón no microcítico, mama, ovario, gástrico y colorrectal.
El estudio incluirá una Parte 1 de Escalación de Dosis y una Parte 2 de Optimización de Dosis. Esto marca el primer programa ADC de Innate en entrar en ensayos clínicos, lo que representa un hito significativo para la empresa.
Innate Pharma는 IPH4502의 IND 신청서가 FDA의 승인을 받았다고 발표했습니다. 이것은 Nectin-4를 표적으로 하는 새로운 탑오이소머라제 I 억제제 항체-약물 접합체(ADC)로, 고형 종양에서 사용됩니다. 이 회사는 곧 1상 임상 연구를 시작할 계획입니다. 연구는 Nectin-4를 발현하는 것으로 알려진 고급 고형 종양에서 단일 약제로서 IPH4502의 안전성, 허용성 및 초기 유효성을 평가하는 다기관 공개 시험이 될 것입니다. 이 고형 종양에는 요로세포 암종, 비소세포 폐암, 유방암, 난소암, 위암 및 대장암이 포함됩니다.
연구는 1부 용량 증량 및 2부 용량 최적화를 포함합니다. 이는 Innate의 첫 번째 ADC 프로그램이 임상 시험에 진입한 것으로, 회사에 중요한 이정표를 나타냅니다.
Innate Pharma a annoncé l'approbation par la FDA de sa demande IND pour IPH4502, un conjugué anticorps-médicament (ADC) novateur inhibiteur de la topoisomérase I ciblant Nectin-4 dans les tumeurs solides. La société prévoit de lancer une étude clinique de Phase 1 dans les mois à venir. L'étude sera un essai multicentrique en ouvert évaluant la scurité, la tolérance et l'efficacité préliminaire de l'IPH4502 en tant qu'agent unique dans les tumeurs solides avancées connues pour exprimer Nectin-4, y compris carcinome urothélial, carcinome pulmonaire non à petites cellules, sein, ovaire, gastrique et colorectal.
L'étude comprendra une Partie 1 d'escalade de dose et une Partie 2 d'optimisation de dose. Cela marque le premier programme ADC d'Innate à entrer dans des essais cliniques, représentant une étape importante pour l'entreprise.
Innate Pharma hat die Genehmigung der FDA für den IND-Antrag für IPH4502 bekannt gegeben, ein neuartiges Antikörper-Wirkstoff-Konjugat (ADC), das als Topoisomerase-I-Hemmer wirkt und Nectin-4 in soliden Tumoren angreift. Das Unternehmen plant, in den kommenden Monaten eine Phase-1-Studie zu starten. Die Studie wird eine offene, multizentrische Prüfung sein, die die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von IPH4502 als Einzelmittel bei fortgeschrittenen soliden Tumoren evaluiert, die Nectin-4 exprimieren, einschließlich urothelialem Karzinom, nicht-kleinzelligem Lungenkarzinom, Brust-, Eierstock-, Magen- und Dickdarmkrebs.
Die Studie wird einen Teil 1 zur Dosissteigerung und einen Teil 2 zur Dosisoptimierung umfassen. Dies markiert das erste ADC-Programm von Innate, das in klinische Studien eintritt, was einen bedeutenden Meilenstein für das Unternehmen darstellt.
- FDA clearance of IND application for IPH4502
- Advancement of first ADC program to clinical trials
- Potential new therapeutic option for multiple solid tumor types
- None.
- IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the
The Phase 1, open-label, multi-center study, includes a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.
“We are thrilled to advance the IPH4502 program, and the IND application acceptance is an important milestone for Innate, as this is our first ADC program to enter the clinic,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. “IPH4502 is a novel and differentiated Nectin-4 ADC that has the potential to provide a new therapeutic option for patients with a cancer expressing a wide range of Nectin-4. Through this Phase 1 study we aim to advance the research on our ADC technology for the benefit of patients.”
About IPH4502
IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues.
In non-clinical models, IPH45 was well tolerated and shows anti-tumor efficacy in vitro and in vivo.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.
Headquartered in
Learn more about Innate Pharma at www.innate-pharma.com and follow us on Twitter and LinkedIn.
Information about Innate Pharma shares
ISIN code |
FR0010331421 |
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Ticker code |
Euronext: IPH Nasdaq: IPHA |
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LEI |
9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking information and risk factors
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Source: Innate Pharma SA
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