Corbus Pharmaceuticals announces data from study of CRB-701

Corbus Pharmaceuticals announced that data from the first-in-human clinical study of CRB-701 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. The Phase 1 dose escalation study is being conducted in China and is enrolling participants with metastatic urothelial cancer as well as participants with other solid tumors prospectively confirmed to have nectin-4 positive tumors. 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. 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 at 1.25 mg/kg Q1W x21 days, CRB-701 consistently demonstrated lower free MMAE concentrations. Efficacy: Dose level 5 and above represents the predicted therapeutically relevant doses based on allometric scaling. A mixed tumor population receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% and a disease control rate of 71%. The longest observed response to date is 11 cycles and ongoing. All nectin-4 positive mUC and cervical patients at doses greater than or equal to 2.7 mg/kg that were assessable at the time of the December 2023 data-cut off demonstrated levels of disease control and represent the CRB-701 responsive population to date.