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24 Sep 2024
Admin
News Article

CD (Suzhou)Biopharma Gets US FDA Clearance to Begin Phase I Trial of CD-001

Overview

CD(Suzhou) Biopharma, a rapidly advancing clinical-stage biotech company, has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of CD-001, entering a phase I first-in-human trial.

About the Lead Candidate: CD-001

CD-001, the company's leading clinical candidate, is built on its proprietary Bispecific FusionProtein (BsFP) platform.
This potential therapy, designed to target PD-1 positive CD8+ T cells using an anti-PD-1 antibody and engineeredIL-21 mutant, aims to address unmet medical needs in oncology and viral infections.

From the CEO: CD Biopharma

"The FDA’s clearance of this IND reinforces our unwavering commitment to advancing ground breaking 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 tumour 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.”

About CD 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.

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