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CD Biopharma's CD-001 Receives FDA Clearance for Phase 1 Trial in Oncology

• CD Biopharma's CD-001, a bispecific fusion protein, has been cleared by the FDA for a Phase 1 clinical trial. • CD-001 targets PD-1-positive, CD8-positive T cells using an anti-PD-1 antibody and an engineered IL-21 mutant. • The Phase 1 trial will assess CD-001 as a potential treatment for solid tumors and hematologic malignancies. • Preclinical studies have demonstrated CD-001's effectiveness in mouse tumor models with good tolerance in non-human primates.

CD Biopharma has announced that the FDA has cleared its Investigational New Drug (IND) application for CD-001, a bispecific fusion protein (BsFP) being developed for the treatment of solid tumors and hematologic malignancies. This clearance paves the way for a Phase 1, first-in-human trial to evaluate the safety and efficacy of CD-001 in patients with advanced cancers.

Novel Immunotherapy Approach

CD-001 is designed to target PD-1-positive, CD8-positive T cells, utilizing an anti-PD-1 antibody and an engineered IL-21 mutant. The agent is built on CD Biopharma’s proprietary BsFP platform. This innovative approach aims to enhance the immune response against cancer cells by selectively activating and expanding tumor-specific T cells.

Preclinical Evidence

According to CD Biopharma, preclinical studies have demonstrated the effectiveness of CD-001 in various mouse tumor models. Furthermore, the company reports that excellent tolerance was observed in non-human primates during preclinical safety assessments.

Clinical Trial Plans

The planned Phase 1 trial will be a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with solid tumors and hematologic malignancies. The trial is expected to begin enrolling patients in the coming months, with initial clinical data anticipated shortly thereafter.

Company Statement

"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. "CD-001 shows promise as a first-in-class and best-in-class treatment."

CD Biopharma's Broader Pipeline

CD Biopharma is focused on developing innovative therapies across a broad spectrum of immunotherapy areas, including oncology, viral infections, and autoimmune diseases. In addition to CD-001, the company is also developing CD-002 for the potential treatment of solid tumors, as well as therapies for HIV and human papillomavirus (HPV). The company's technology platforms include the BsFP platform and IMmune-Enhanced (IME) cell technology.
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Reference News

[1]
FDA Clears Investigational New Drug Application for CD-001 in Oncology
targetedonc.com · Sep 20, 2024

FDA clears CD-001 IND, allowing phase 1 trial entry for solid tumors and hematologic malignancies. CD-001, based on CD B...

[2]
CD (Suzhou) Biopharma Announces FDA Clearance for Phase I Clinical Trial of CD-001
prnewswire.com · Sep 20, 2024

CD (Suzhou) Biopharma received FDA clearance for its CD-001 IND, entering a Phase I trial. CD-001, based on the Bispecif...

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