FDA Fast Tracks CRB-701 for Relapsed/Refractory Metastatic Cervical Cancer

Corbus Pharmaceuticals Holdings, Inc., a pharmaceutical company focused on oncology and obesity, announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to their drug, CRB-701, for treating relapsed or refractory metastatic cervical cancer. CRB-701, also known as SYS6002, is a state-of-the-art antibody drug conjugate (ADC) that specifically targets Nectin-4 and employs a cleavable linker along with a precise drug antibody ratio of 2, utilizing MMAE as the payload. The FDA's Fast Track designation aims to accelerate the development and review process of drugs that treat severe conditions and address unmet medical needs.

Corbus recently completed the patient enrollment phase of its Phase 1 clinical trial for CRB-701 (SYS6002), identified by the code NCT06265727, which is being carried out in the United States and Europe. This three-part Phase 1 trial is designed to assess the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors that exhibit high levels of Nectin-4 expression. The company anticipates releasing the initial data from this dose escalation study in the first quarter of 2025.

Based in Norwood, Massachusetts, Corbus Pharmaceuticals Holdings, Inc. is dedicated to tackling serious illnesses through innovative scientific approaches targeting well-understood biological pathways. Their pipeline includes several promising drugs, such as CRB-701, which targets Nectin-4 expression on cancer cells to deliver a cytotoxic payload; CRB-601, an anti-integrin monoclonal antibody that inhibits TGFβ activation on cancer cells; and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist aimed at treating obesity.

For more details on Corbus Pharmaceuticals and their innovative approaches to treating serious illnesses, visit their website.