CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024

• Q3W schedule of CRB-701 (SYS6002) demonstrates a 43% ORR and 71% DCR at predicted therapeutically relevant doses
  
• All assessable nectin-4 positive study participants with mUC and cervical cancer treated at or above this dose demonstrated some level of disease control
• No dose limiting toxicities (DLTs) have been observed to-date up to 3.6 mg/kg (cohort 6) with further escalation at 4.5 mg/kg ongoing
• No cases of peripheral neuropathy or skin rash have been observed to date
• Cohort 6 is the first cohort selected for dose expansion
  

NORWOOD, Mass., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that data from the first-in-human clinical study of CRB-701 (SYS6002) is being presented as a poster by the Company’s development partner CSPC Pharmaceutical Group at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The Phase 1 dose escalation study is being conducted in China and is enrolling participants with metastatic urothelial cancer (mUC) as well as participants with other solid tumors prospectively confirmed to have nectin-4 positive tumors. The study opened for enrollment in January 2023 and data through December 2023 from the first eighteen participants reflective of the first six dose cohorts (0.2-3.6mg/kg) will be shared.

The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST. The poster will also be available on the Corbus website at the start of the poster presentation.

Safety

• CRB-701 was well-tolerated with the majority of adverse events being grade one or two and reversible.
• No adverse events above grade three were observed.
• There have been no dose discontinuations or reductions in the study to date. There has been a singular participant that experienced a temporary dose interruption.
• The dose escalation is ongoing at cohort 7 (4.5 mg/kg).
• No cases of drug-related peripheral neuropathy or skin rash have been reported to date.
  

PK

• Single dose PK suggested that TAb, ADC and MMAE increase in an approximate dose proportional manner.
• No obvious accumulation was observed on cycle 3, day 1.
• When compared to the exposures achieved with enfortumab vedotin (EV) at 1.25 mg/kg Q1W x21 days, CRB-701 (SYS6002) consistently demonstrated lower free MMAE concentrations.