FDA Clears Investigational New Drug Application for CD-001 in Oncology

• The FDA granted clearance to the investigational new drug (IND) application of CD-001.
• CD-001 is built on CD (Suzhou) Biopharma’s proprietary Bispecific Fusion Protein (BsFP) platform.
• With this IND clearance, CD-001 will enter a first-in-human, phase 1 trial.

The IND application of CD-001 has been cleared by the FDA.¹

CD-001 is a therapy that is designed to target PD-1–positive, CD8-positive T cells using an anti-PD–1 antibody and engineered IL-21 mutant. The agent is built on CD Biopharma’s proprietary BsFP platform and is being evaluated for the treatment of patients with solid tumors and hematologic malignancies.²

Following this IND clearance, a phase 1, first-in-human trial plans to evaluate CD-001.¹

Small tumor cancer cells: © Yuriy - stock.adobe.com

"The FDA's clearance of this IND reinforces our unwavering commitment to advancing groundbreaking immunotherapies." said Jian Xu, PhD, chief executive officer of CD Biopharma, in a press release. "CD-001 shows promise as a first-in-class and best-in-class treatment, and preclinical studies have demonstrated its effectiveness in various mouse tumor models, with excellent tolerance observed in non-human primates.”

CD Biopharma’s research and development cover a broad spectrum in immunotherapy. This includes oncology, viral infections, and autoimmune diseases.²

While CD-001 is being developed for patients with solid tumors and hematologic malignancies, the agent is also being evaluated for the treatment of HIV and human papillomavirus (HPV). Another agent being developed by the company is CD-002 for the potential treatment of solid tumors.

In addition to the proprietary BsFP, CD Biopharma also has IMmune-Enhanced (IME) cell technology for advanced cell modification. Initial clinical data from both platforms have been gathered from prior investigator-initiated trials.

“We are excited to move forward with patient enrollment and expect initial clinical data in the upcoming months,” added Xu in the press release.

REFERENCES:

1. CD (Suzhou) Biopharma announces FDA clearance for phase I clinical trial of CD-001. News release. September 20, 2024. Accessed September 20, 2024. https://tinyurl.com/399atn56

2. R&D pipeline. CD Biopharma. Accessed September 20, 2024. https://www.cdbiopharma.com/en_yfgx.html