CD Biopharma Receives US FDA No to commence phase I trial

Suzhou-based CD Biopharma, a fast-growing biotech company in the clinical stage, has been approved by the FDA for its CD-001 Investigational New Drug (IND) application, marking the start of a phase I human trial.

The company's top clinical candidate, CD-001, is developed using its unique Bispecific FusionProtein (BsFP) platform. This new treatment targets PD-1 positive CD8+ T cells with an anti-PD-1 antibody and engineered IL-21 mutant to help with medical needs in oncology and viral infections.

"The FDA’s clearance of this IND reinforces our unwavering commitment to advancing ground breaking immunotherapies." said Dr. Jian Xu, CEO of CD Biopharma. “CD-001 shows promise as a first-in-class and best-in-class treatment, and preclinical studies have demonstrated its effectiveness in various mouse tumour models, with excellent tolerance observed in non-human primates. We are excited to move forward with patient enrollment and expect initial clinical data in the upcoming months.”

Established in 2021, CD Biopharma is a fast-growing clinical-stage biotech company dedicated to creating groundbreaking therapies in various areas of immunotherapy such as oncology, viral infections, and autoimmune diseases. They possess a technology platform for the exploration and development of bispecific fusion proteins. Monoclonal antibody screening, identification, and optimization were utilized to prepare antibody molecules, which were then used to construct dual-target drugs.