CD Biopharma receives FDA clearance for Phase I trial in Suzhou

On September 20, 2024, CD (Suzhou) Biopharma announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for CD-001. This marks a significant milestone for the company as it prepares to enter a Phase I first-in-human clinical trial. CD-001 is the leading candidate developed by the company, utilizing its proprietary Bispecific Fusion Protein (BsFP) platform. The therapy is specifically designed to target PD-1 positive CD8+ T cells, combining an anti-PD-1 antibody with an engineered IL-21 mutant. This innovative approach aims to address critical unmet medical needs in the fields of oncology and viral infections, which are areas of high demand for effective treatments. Dr. Jian Xu, the CEO of CD Biopharma, expressed enthusiasm about the FDA's clearance, emphasizing the company's commitment to advancing groundbreaking immunotherapies. The clearance allows the company to move forward with patient enrollment for the trial, which is a crucial step in the development of CD-001. Initial clinical data from the trial is expected to be available in the coming months, which could provide valuable insights into the efficacy and safety of this potential therapy. The successful progression of this trial could have significant implications for the treatment landscape in oncology and viral infections, potentially benefiting many patients in need of new therapeutic options.