Crescent Biopharma announces regulatory clearance of IND applications

Crescent Biopharma (CBIO) announced regulatory clearances of Investigational New Drug applications for CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an integrin beta-6-targeted antibody drug-conjugate, both being developed for the treatment of advanced solid tumors. The U.S. Food and Drug Administration has cleared Crescent’s IND for CR-001, and Crescent’s partner Sichuan Kelun-Biotech Biopharmaceutical has received IND approval for CR-003 from the Center for Drug Evaluation of the National Medical Products Administration of China. The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naive and previously treated patients with multiple solid tumor types, including non-small cell lung cancer and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity in first-line and previously treated patients.