Corbus Pharmaceuticals announces FDA clearance of IND application of CRB-601

Corbus Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, has cleared the investigational new drug application of CRB-601, a potentially best-in-class TGFbeta blocking monoclonal antibody targeting the integrin alphavbeta8. Pre-clinical data presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer, SITC, demonstrates CRB-601 overcame tumor immune exclusion and enhanced the activity of immune checkpoint inhibitors in vivo. The Company expects to enroll the first participant in a Phase 1 study in the first half of 2024. “Pre-clinical data generated to-date demonstrates that CRB-601 has robust anti-tumor activity as monotherapy and in combination with anti-PD-1 therapy in a variety of solid tumors exhibiting a range of sensitivities to PD(L)-1 targeted therapy,” said Yuval Cohen Ph.D., Chief Executive Officer of Corbus. “CRB-601 blocked latent TGFbeta activation and enhanced immune cell penetration into the tumor microenvironment in pre-clinical models. We believe this mechanism of action is complimentary to the effects of anti PD(L)-1 therapy leading to enhanced combinatorial efficacy. We look forward to initiating our Phase 1 First-in-Human trial of CRB-601 and anticipate enrolling the first participant in the first half of this year.”