CD (Suzhou) Biopharma Announces FDA Approval for Phase I Clinical Trial of CD-001

SUZHOU, China, September 20, 2024 /PRNewswire/ — CD (Suzhou) Biopharma has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for CD-001, moving the company into a first-in-human Phase I trial.

CD-001, the company’s lead 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 an engineered IL-21 mutant, is aimed at addressing unmet medical needs in oncology and viral infections.

“The FDA’s approval of this IND underscores our continued commitment to developing breakthrough immunotherapies,” said Dr. Jian XuCEO of CD Biopharma. “CD-001 shows promise as a first-in-class and best-in-class treatment, and preclinical studies have demonstrated its efficacy in several mouse tumor models, with excellent tolerability observed in non-human primates. We are excited to move forward with patient enrollment and anticipate initial clinical data in the coming months.”

About CD (Suzhou) Biopharma

Founded in 2021, CD Biopharma is a fast-growing clinical-stage biotech company focused on the development of 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, Chinawith additional research activities in Beijing, China.

For more information, visit https://www.cdbiopharma.com/.

CONTACT:
Email address: [email protected]

View original content:https://www.prnewswire.com/news-releases/cd-suzhou-biopharma-announces-fda-approval-for-phase-i-clinical-trial-of-cd-001-302254044.html

SOURCE CHENGDIAN (SUZHOU) BIOPHARMACEUTICAL CO., LTD