On September 20, 2024 CD (Suzhou) Biopharma reported to have 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 (Press release, CD Biopharma, SEP 20, 2024, View Source [SID1234646775]).

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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.

"The FDA’s clearance of this 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 demonstrated its 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 in the upcoming months."