CD (Suzhou) BiopharmaAnnounces FDA Clearance for Phase I Clinical Trial of CD-001
Suzhou, China – September20, 2024 – CD(Suzhou) Biopharma has received clearance from the U.S. Food andDrug Administration (FDA) for its Investigational New Drug (IND)application of CD-001, entering a Phase I first-in-human trial.
CD-001, the company's leadingclinical candidate, is built on its proprietary Bispecific FusionProtein (BsFP) platform. This potential therapy, designed to targetPD-1 positive CD8+ T cells using an anti-PD-1 antibody and engineeredIL-21 mutant, aims to address unmet medical needs in oncology andviral infections.
"The FDA’s clearance ofthis IND reinforces our unwavering commitment to advancinggroundbreaking immunotherapies." said Dr. Jian Xu, CEO of CDBiopharma. “CD-001 shows promise as a first-in-class andbest-in-class treatment, and preclinical studies have demonstratedits effectiveness in various mouse tumor models, with excellenttolerance observed in non-human primates. We are excited to moveforward with patient enrollment and expect initial clinical data inthe upcoming months.”
About CD (Suzhou) Biopharma
Founded in 2021, CD Biopharma isa rapidly advancing clinical-stage biotech company focused ondeveloping innovative therapies across a broad spectrum ofimmunotherapy areas, including oncology, viral infections, andautoimmune diseases. The company’s proprietary Bispecific FusionProtein (BsFP) platform and IMmune-Enhanced (IME) cell technology,which enable advanced cell modification, continue to drivebreakthrough research and clinical outcomes that transform patientcare. CD Biopharma is headquartered in Suzhou, China, with additionalresearch operations in Beijing, China.
For more information, visithttps://www.cdbiopharma.com/.
