Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) has announced the presentation of a clinical update related to the first-in-human trial of SYS6002 (CRB-701), a next-generation nectin-4 targeting antibody drug conjugate, at the American Society of Clinical Oncology (ASCO) annual conference. The update highlighted the safety and efficacy of SYS6002 in patients with nectin-4 positive tumors.
Since January 2024, an additional 19 patients have been enrolled, bringing the total to 37, of whom 25 were evaluable for efficacy. SYS6002 demonstrated a 44% Overall Response Rate (ORR) and 78% Disease Control Rate (DCR) in metastatic urothelial cancer (MUC) and a 43% ORR and 86% DCR in cervical cancer at doses ≥ 1.2mg/kg. Notably, no dose-limiting toxicities (DLTs) have been observed to date in doses up to and including 4.5 mg/kg.
The emerging clinical safety profile indicated that SYS6002 was generally well-tolerated, with mainly grade 1 or 2 adverse events. No grade 4 or 5 adverse events have been observed to date. The most common treatment-related adverse events were anemia and eye-related issues. Skin rash and peripheral neuropathy were reported, with one case of grade 3 rash and one case of grade 1 neuropathy, both of which resolved.
In terms of emerging efficacy, anti-tumor responses across multiple doses continue to be observed, with the first confirmed stable disease at 0.6 mg/kg and the first confirmed partial response at 1.2 mg/kg. SYS6002 resulted in a 44% ORR and 78% DCR in MUC and a 43% ORR and 86% DCR in cervical cancer.
Furthermore, in terms of clinical pharmacology, after a single IV infusion of SYS6002, the exposure of ADC and MMAE generally increased in a dose-proportional manner up to 2.7 mg/kg, beyond which a leveling off of free MMAE was observed. All dose levels studied to date showed lower average levels of free MMAE than enfortumab vedotin at the reference dose.
Dr. Yuval Cohen, Chief Executive Officer at Corbus, expressed encouragement by the latest data release and highlighted the expected completion of the corresponding US clinical study in Q4, with data presentation in Q1 2025.
The market has reacted to these announcements by moving the company's shares 10.5% to a price of $47.3. If you want to know more, read the company's complete 8-K report here.
