CD-001

CD-001 is a first-in-class bispecific fusion protein therapy developed by CD Biopharma. It is designed to target PD-1–positive, CD8-positive T cells using an anti-PD-1 antibody fused with an engineered interleukin-21 (IL-21) mutant. The drug leverages the company’s proprietary Bispecific Fusion Protein (BsFP) platform and aims to address critical unmet needs in oncology and viral infections. Mechanistically, it acts as both a PD-1 inhibitor and IL-21 receptor agonist, thereby enhancing immune responses against tumors or infected cells. Preclinical studies have shown promising antitumor activity in mouse models and good tolerance in non-human primates. The agent is being evaluated for solid tumors, hematologic malignancies, HIV infection, and human papillomavirus (HPV) infection[1][2][3][4][5].