FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer
Corbus Pharmaceuticals announced that the FDA has granted Fast Track designation to CRB-701 for treating relapsed or refractory metastatic cervical cancer. CRB-701 is a next-generation antibody drug conjugate targeting Nectin-4, featuring a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE payload. The company has completed enrollment for the dose escalation portion of its Phase 1 clinical trial, which is evaluating safety, pharmacokinetics, and efficacy in patients with advanced solid tumors associated with high Nectin-4 expression. Initial data from the dose escalation study is expected in Q1 2025.
Corbus Pharmaceuticals ha annunciato che la FDA ha concesso la designazione Fast Track a CRB-701 per il trattamento del cancro cervicale metastatico in recidiva o refrattario. CRB-701 è un anticorpo coniugato di nuova generazione che mira a Nectin-4, con un legante specifico per il sito e cleavabile, e un rapporto preciso tra farmaco e anticorpo di 2 utilizzando un payload di MMAE. La società ha completato l'arruolamento per la parte di escalazione della dose del suo studio clinico di Fase 1, che valuta sicurezza, farmacocinetica ed efficacia in pazienti con tumori solidi avanzati associati a un'alta espressione di Nectin-4. I dati iniziali dello studio di escalazione della dose sono attesi nel primo trimestre del 2025.
Corbus Pharmaceuticals anunció que la FDA ha otorgado la designación de Vía Rápida a CRB-701 para el tratamiento del cáncer cervical metastásico en recaída o refractario. CRB-701 es un conjugado de anticuerpo de nueva generación que apunta a Nectin-4, presentando un enlace específico para el sitio y escindible, además de una relación precisa de medicamento-anticuerpo de 2 utilizando el payload de MMAE. La compañía ha completado la inscripción para la parte de escalada de dosis de su ensayo clínico de Fase 1, que evalúa la seguridad, farmacocinética y eficacia en pacientes con tumores sólidos avanzados asociados con alta expresión de Nectin-4. Se esperan datos iniciales del estudio de escalada de dosis en el primer trimestre de 2025.
Corbus Pharmaceuticals는 FDA가 재발성 또는 불응성 전이 자궁경부암 치료를 위한 CRB-701에 신속 심사 지정을 부여했다고 발표했습니다. CRB-701은 Nectin-4를 타겟으로 하는 차세대 항체 약물 접합체로, 사이트 특이적이며 절단 가능한 링커와 MMAE 페이로드를 사용하는 정확한 약물-항체 비율 2를 특징으로 합니다. 이 회사는 1상 임상 시험의 용량 상승 부분에 대한 모집을 완료하였으며, 이는 고 Nectin-4 발현과 관련된 진행된 고형암 환자의 안전성, 약리학적 동태 및 효능을 평가합니다. 용량 상승 연구의 초기 데이터는 2025년 1분기에 발표될 예정입니다.
Corbus Pharmaceuticals a annoncé que la FDA a accordé la dénomination Fast Track à CRB-701 pour le traitement du cancer du col de l'utérus métastatique récidivant ou réfractaire. CRB-701 est un conjugué médicament-anticorps de nouvelle génération ciblant Nectin-4, avec un liant spécifique et clivable ainsi qu'un rapport médicament-anticorps précis de 2 utilisant le payload MMAE. La société a terminé l'inscription pour la partie d'escalade de dose de son essai clinique de phase 1, qui évalue la sécurité, la pharmacocinétique et l'efficacité chez des patients ayant des tumeurs solides avancées associées à une forte expression de Nectin-4. Les premières données de l'étude d'escalade de dose sont attendues au premier trimestre 2025.
Corbus Pharmaceuticals gab bekannt, dass die FDA CRB-701 die Fast-Track-Status zur Behandlung von rezidivierenden oder refraktären metastasierenden Zervixkarzinom gewährt hat. CRB-701 ist ein Antikörper-Wirkstoff-Konjugat der nächsten Generation, das auf Nectin-4 abzielt und einen spezifischen, spaltbaren Linker sowie ein präzises Verhältnis von 2 zwischen Wirkstoff und Antikörper unter Verwendung des MMAE-Lastes aufweist. Das Unternehmen hat die Rekrutierung für den Dosissteigerungsteil seiner Phase-1-Studie abgeschlossen, die Sicherheit, Pharmakokinetik und Wirksamkeit bei Patienten mit fortgeschrittenen soliden Tumoren mit hoher Nectin-4-Expression untersucht. Erste Daten aus der Dosissteigerungsstudie werden im ersten Quartal 2025 erwartet.
- FDA Fast Track designation received for CRB-701
- Completed enrollment in dose escalation portion of Phase 1 trial
- Clinical trial data expected in Q1 2025
- None.
Insights
This Fast Track designation significantly enhances CRB-701's development pathway for cervical cancer treatment. The designation is particularly noteworthy given the high unmet medical need in relapsed/refractory metastatic cervical cancer. Key advantages include:
- Enhanced FDA interaction and guidance
- Rolling review potential for future submissions
- Potential eligibility for accelerated approval
The ongoing Phase 1 trial's completion of dose escalation enrollment is promising, especially with the precise drug-antibody ratio of 2 and MMAE payload. Nectin-4 targeting has shown success in other ADCs, notably enfortumab vedotin in bladder cancer. The Q1 2025 data readout timeline provides a clear catalyst for potential value creation.
NORWOOD, Mass., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer. CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE as the payload.
The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions that demonstrate the potential to fill an unmet medical need.
Corbus recently completed enrollment of the dose escalation part of its Phase 1 clinical trial of CRB-701 (SYS6002) (NCT06265727) that is being conducted in the U.S. and Europe. The three-part Phase 1 trial is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression. The Company expects to report the first data from the dose escalation clinical study in Q1 2025.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
FAQ
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