CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting ADC Demonstrates Encouraging Safety and Broader Efficacy in Phase 1 Study in the US and UK Presented at ASCO-GU 2025

• Study mirrored 4 highest doses used in China dose escalation study presented at ASCO 2024
• Safety, tolerability and PK comparable to China dataset with no DLTs observed in either study
• Low levels of peripheral neuropathy and skin toxicity observed in both studies
• Clinical responses seen in urothelial (mUC) and cervical cancer participants in both studies
• First time targeting of head and neck squamous cell carcinoma (HNSCC) with CRB-701 yields multiple responses
• Dose optimization is underway with dosing at 2.7 mg/kg and 3.6 mg/kg Q3W

Excerpt from the Press Release:

NORWOOD, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) (“Corbus” or the “Company”), announced that data from its US and UK conducted first-in-human dose escalation clinical study (“Western study”) of CRB-701 (SYS6002) is being presented today at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).

The poster is titled Phase 1 Dose-Escalation Study of Next-Generation Nectin-4 Targeting Antibody-Drug Conjugate CRB-701 (SYS6002) in US and UK Patients with Urothelial Cancer and Other Solid Tumors (Perez, et al) and is being presented today between 11:30 am-12:45 pm PST. The poster will also be available on the Corbus website at the start of the poster presentation.

This Phase 1 Western dose escalation study enrolled participants with metastatic urothelial cancer (mUC) and other solid tumors associated with Nectin-4 expression. These included several tumor types not previously explored in China. Unlike the China study, participants were recruited regardless of their individual Nectin-4 levels. The Western study opened for enrollment in April 2024 and enrollment for dose escalation was completed in October 2024. A December 2024 data cut is being presented (n=38) of whom 26 participants were evaluable for efficacy. The Western study enrolled into the top four dose cohorts used in China (1.8, 2.7, 3.6 and 4.5 mg/kg) and adopted the same Q3W regimen.  

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