Exciting News | CD Biopharma's CD-001 Study Initiates at Lead Clinical Site

SUZHOU, China, January 6, 2025 - CD (Suzhou) Biopharma announces that its CD-001-CT101 study was officially initiated at Tianjin Medical University Cancer Institute & Hospital on January 2nd, marking a significant advancement in the clinical trial program.

 

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"Following the project initiation meeting on December 3rd, 2024, the CD Biopharma and WuXi Clinical teams demonstrated exceptional operational efficiency by completing the entire process from project establishment to formal site activation within just 30 days," reported WuXi Clinical, the contract research organization (CRO) partner for the study.

 

The successful launch reflects strong multi-center collaboration. As noted by WuXi Clinical, "The scientific expertise and resource support from Tianjin Medical University Cancer Institute & Hospital have provided both academic rigor and implementation assurance. The seamless coordination between all three parties enabled rapid progression from protocol development to study execution."

 

CD Biopharma will continue to maintain its professional and rigorous approach, providing comprehensive support for the successful conduct of the study. We look forward to working hand in hand with all partners to advance pharmaceutical innovation.

 

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.

Preclinical studies have demonstrated potent anti-tumor activity across multiple tumor models in mice, with a favorable safety and pharmacokinetic profile observed in non-human primate toxicology studies. The program has received IND clearance from both the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) for advanced solid tumors, and an additional IND application for hematological malignancies is currently under review by NMPA.

 

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.