SUZHOU, China, Sept. 20, 2024 -- CD Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND)application of CD-001, entering a Phase I first-in-human trial.
"The FDA’s clearance ofthis IND reinforces our unwavering commitment to advancing groundbreaking 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 demonstratedits effectiveness in various mouse tumor models, with excellent tolerance observed in non-human primates. We are excited to move forward with patient enrollment and expect initial clinical data inthe upcoming months.”
About CD-001
CD-001, the company's leading clinical candidate, is built on its proprietary Bispecific Fusion Protein (BsFP) platform. This potential therapy, designed to target PD-1 positive CD8⁺ T cells using an anti-PD-1 antibody and engineered IL-21 mutant, aims to address unmet medical needs in oncology and viral infections.
About CD (Suzhou) Biopharma
Founded in 2021, CD Biopharma is a rapidly advancing clinical-stage biotech company focused on developing innovative therapies across a broad spectrum of immunotherapy areas, including oncology, viral infections, and autoimmune diseases. The company's proprietary Bispecific Fusion Protein (BsFP) platform and IMmune-Enhanced (IME) cell technology, which enable advanced cell modification, continue to drive breakthrough research and clinical outcomes that transform patient care. CD Biopharma is headquartered in Suzhou, China, with additional research operations in Beijing, China.
