Innate Pharma Announces First Patient Dosed in Phase 1 Study of Its Nectin-4 Targeting Antibody Drug Conjugate IPH4502 in Selected Advanced Solid Tumors
Innate Pharma has announced the dosing of the first patient in its Phase 1 study of IPH4502, a novel antibody-drug conjugate (ADC) targeting Nectin-4, in patients with advanced solid tumors. The study (NCT06781983) will evaluate the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent.
The trial consists of two parts: Part 1 Dose Escalation and Part 2 Dose Optimization, planning to enroll approximately 105 patients. The study targets tumors known to express Nectin-4, including urothelial carcinoma, breast cancer, non-small cell lung cancer, and gastro-intestinal cancer.
IPH4502 is designed with a differentiated topoisomerase I inhibitor payload, potentially offering benefits for patients with tumors resistant to MMAE-ADC. The drug targets tumors with both high and low Nectin-4 expression levels, supporting its development beyond urothelial carcinoma.
Innate Pharma ha annunciato la somministrazione della prima dose al paziente nel suo studio di Fase 1 su IPH4502, un innovativo coniugato di anticorpo-farmaco (ADC) mirato a Nectin-4, in pazienti con tumori solidi avanzati. Lo studio (NCT06781983) valuterà la sicurezza, la tollerabilità e l'efficacia preliminare di IPH4502 come agente singolo.
Il trial è composto da due parti: Parte 1 Escalation della Dose e Parte 2 Ottimizzazione della Dose, con l'intenzione di arruolare circa 105 pazienti. Lo studio si concentra sui tumori noti per esprimere Nectin-4, inclusi il carcinoma uroteliale, il cancro al seno, il carcinoma polmonare non a piccole cellule e il cancro gastro-intestinale.
IPH4502 è progettato con un payload inibitore della topoisomerasi I differenziato, potenzialmente offrendo vantaggi per i pazienti con tumori resistenti all'MMAE-ADC. Il farmaco mira a tumori con livelli di espressione di Nectin-4 sia elevati che bassi, supportando il suo sviluppo oltre il carcinoma uroteliale.
Innate Pharma ha anunciado la dosificación del primer paciente en su estudio de Fase 1 de IPH4502, un nuevo conjugado de anticuerpo-fármaco (ADC) dirigido a Nectin-4, en pacientes con tumores sólidos avanzados. El estudio (NCT06781983) evaluará la seguridad, tolerancia y eficacia preliminar de IPH4502 como agente único.
El ensayo consta de dos partes: Parte 1 Escalamiento de Dose y Parte 2 Optimización de Dosis, con una planificación para inscribir aproximadamente a 105 pacientes. El estudio se dirige a tumores conocidos por expresar Nectin-4, incluidos carcinoma urotelial, cáncer de mama, cáncer de pulmón no microcítico y cáncer gastrointestinal.
IPH4502 está diseñado con una carga diferenciada de inhibidor de topoisomerasa I, lo que potencialmente ofrece beneficios para pacientes con tumores resistentes a MMAE-ADC. El fármaco tiene como objetivo tumores con altos y bajos niveles de expresión de Nectin-4, apoyando su desarrollo más allá del carcinoma urotelial.
Innate Pharma는 고형 종양이 진행된 환자를 대상으로 Nectin-4를 표적으로 하는 새로운 항체-약물 접합체(ADC)인 IPH4502의 1상 임상시험에서 첫 번째 환자에게 투여를 시작했다고 발표했습니다. 이 연구(NCT06781983)는 IPH4502 단일제로서의 안전성, 내약성 및 초기 효능을 평가할 것입니다.
시험은 두 부분으로 구성되어 있습니다: 1부 용량 증량 및 2부 용량 최적화를 통해 약 105명의 환자를 등록할 계획입니다. 이 연구는 Nectin-4를 발현하는 것으로 알려진 종양을 대상으로 하며, 여기에는 요로 상피 암, 유방암, 비소세포 폐암 및 위장관 암이 포함됩니다.
IPH4502는 차별화된 톱오이소머라제 I 억제제 페이로드로 설계되어 있으며, MMAE-ADC에 저항성이 있는 종양을 가진 환자에게 이점을 제공할 가능성이 있습니다. 이 약물은 높은 Nectin-4 발현 수준과 낮은 발현 수준의 종양을 표적으로 하여 요로 상피 암을 넘어서는 개발을 지원합니다.
Innate Pharma a annoncé la posologie du premier patient dans son étude de phase 1 de IPH4502, un nouveau conjugué anticorps-médicament (ADC) ciblant Nectin-4, chez des patients atteints de tumeurs solides avancées. L'étude (NCT06781983) évaluera la sécurité, la tolérance et l'efficacité préliminaire de l'IPH4502 en tant qu'agent unique.
Le procès se compose de deux parties : Partie 1 Élévation de la dose et Partie 2 Optimisation de la dose, prévoyant d'inscrire environ 105 patients. L'étude cible des tumeurs connues pour exprimer Nectin-4, y compris le carcinome urothélial, le cancer du sein, le cancer du poumon non à petites cellules et le cancer gastro-intestinal.
IPH4502 est conçu avec une charge d'inhibiteur de la topoisomérase I différenciée, offrant potentiellement des avantages aux patients dont les tumeurs sont résistantes à l'ADC MMAE. Le médicament cible à la fois les tumeurs à expression élevée et faible de Nectin-4, soutenant son développement au-delà du carcinome urothélial.
Innate Pharma hat die Dosisgabe an den ersten Patienten in seiner Phase-1-Studie zu IPH4502, einem neuartigen Antikörper-Wirkstoff-Konjugat (ADC), das auf Nectin-4 abzielt, bei Patienten mit fortgeschrittenen soliden Tumoren angekündigt. Die Studie (NCT06781983) wird die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von IPH4502 als Einzelmittel bewerten.
Die Studie besteht aus zwei Teilen: Teil 1 Dosiserhöhung und Teil 2 Dosisoptimierung, mit der Planung, etwa 105 Patienten zu rekrutieren. Die Studie richtet sich an Tumoren, von denen bekannt ist, dass sie Nectin-4 exprimieren, einschließlich urothelialem Karzinom, Brustkrebs, nicht-kleinzelligem Lungenkrebs und gastrointestinalen Krebs.
IPH4502 wurde mit einer differenzierten Topoisomerase-I-Hemmer-Ladung entwickelt, was potenzielle Vorteile für Patienten mit resistenten Tumoren gegenüber MMAE-ADC bieten könnte. Das Medikament zielt auf Tumoren mit sowohl hohem als auch niedrigem Nectin-4-Expressionsniveau ab und unterstützt seine Entwicklung über das uroteliale Karzinom hinaus.
- Novel ADC targeting Nectin-4 enters clinical development phase
- Drug designed to work on both high and low Nectin-4 expression tumors
- Potential effectiveness against MMAE-ADC resistant tumors
- Broad application across multiple cancer types
- Early-stage Phase 1 trial with long development timeline ahead
- Safety and efficacy yet to be demonstrated
Insights
The initiation of Phase 1 trials for IPH4502 represents a significant strategic advancement for Innate Pharma in the rapidly expanding ADC market. The drug's unique mechanism combining a topoisomerase I inhibitor payload with Nectin-4 targeting demonstrates notable differentiation from current market leaders like enfortumab vedotin, which uses an MMAE payload.
Several key technical advantages position IPH4502 favorably: First, its ability to target tumors with varying Nectin-4 expression levels could potentially expand the addressable patient population beyond traditional indications like urothelial carcinoma. Second, the differentiated payload mechanism could provide options for patients who have developed resistance to MMAE-based therapies, addressing a critical unmet need in the treatment landscape.
The trial's comprehensive design targeting multiple solid tumor types - including urothelial, lung, breast, ovarian, gastric, esophageal and colorectal cancers - indicates a broad development strategy. With a planned enrollment of 105 patients, the study size is appropriate for generating robust safety and preliminary efficacy data to inform future development decisions.
From a market perspective, this represents Innate Pharma's strategic entry into the high-value ADC space, which has seen multiple successful commercializations and significant deal activity. The broad tumor-type approach could potentially address a substantial market opportunity across multiple indications, though competition from both marketed products and other development programs will be a key factor to monitor.
- IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1 study (NCT06781983), investigating the safety and tolerability of IPH4502, an innovative Antibody-Drug Conjugate (ADC), in patients with advanced solid tumors known to express Nectin-4.
IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC designed to precisely target Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, including urothelial carcinoma (UC), breast cancer, non-small cell lung cancer or gastro-intestinal cancer. IPH4502 targets tumors with a wide range of Nectin-4 expression, supporting its development beyond UC. IPH4502 differentiated topoisomerase I inhibitor payload supports its potential in patients with tumors resistant to MMAE-ADC.
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, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.
“We are thrilled to initiate the Phase 1 study with IPH4502, a promising therapy for patients with advanced solid tumors known to express Nectin-4,” said Dr Shiraj Sen, Medical Oncologist and Phase 1 Investigator, Director of Clinical Research, NEXT Oncology-Dallas. “IPH4502 is uniquely designed to target tumors with both high and low expression of Nectin-4, offering hope for improved outcomes in a population where effective treatment options are limited, and relapses occur frequently. This study represents an important step forward in advancing innovative care for these patients.”
“The initiation of this Phase 1 trial represents a significant milestone for Innate Pharma as our clinical stage pipeline now includes targeted ADCs. We are optimistic about the potential of IPH4502 to address unmet needs in the treatment of advanced solid tumors, with a well differentiated Nectin-4 targeting and the promise of ADC technology to provide a new therapeutic option for patients,” added Dr Sonia Quaratino, Chief Medical Officer at Innate Pharma.
More information about the trial can be found on clinicaltrials.gov.
About IPH4502
IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. It is currently investigated in a Phase 1 trial in advanced solid tumors expressing 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 is well tolerated and shows anti-tumor activity 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 three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).
Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.
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.
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Learn more about Innate Pharma at www.innate-pharma.com. Follow us on LinkedIn and X.
Information about Innate Pharma shares
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Ticker code |
Euronext: IPH Nasdaq: IPHA |
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Source: Innate Pharma SA
FAQ
What is the primary purpose of Innate Pharma's Phase 1 trial for IPH4502 (IPHA)?
How many patients will be enrolled in the IPH4502 Phase 1 trial (IPHA)?
Which types of cancers will be targeted in the IPH4502 trial (IPHA)?
What makes IPH4502 (IPHA) different from other Nectin-4 targeting drugs?
