SUZHOU, China, January 20, 2025 - CD (Suzhou) Biopharma announced that the first patient has been successfully dosed in Phase I clinical trial evaluating CD-001 in patients with advanced solid tumors. The patient was reported to be stable following the initial administration of CD-001.
The milestone comes just one month after receiving IND clearance from China NMPA in December 2024, showcasing the clinical trial center's renowned operational efficiency at Tianjin Medical University Cancer Institute and Hospital. The rapid progress from IND to first patient (FPI) dosed in demonstrates CD Biopharma's outstanding operational capabilities and sets a solid foundation for the program's development. The study is being conducted by principal investigator, Professor Jihui Hao, President of Tianjin Medical University Cancer Institute and Hospital, whose team has provided outstanding support throughout the trial initiation.
Professor Jun Yu, Director of Pancreatic Center and Clinical Trial Office at Tianjin Medical University Cancer Institute and Hospital, commented, "We are pleased to serve as the lead center for this promising program. The preclinical data package for CD-001 has been encouraging, and we look forward to leveraging our extensive experience in solid tumor trials to advance this innovative therapy efficiently and rigorously in collaboration with CD."
"The seamless coordination among all parties has enabled this rapid progress from IND to clinic," said Dr. Jian Xu, CEO of CD Biopharma. "We remain committed to working closely with our investigators to conduct a high-quality study that may ultimately bring new treatment options to patients in need."
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 U.S. Food and Drug Administration (FDA) and China 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.
