Antengene’s First-in-Class CD24 mAb ATG-031 Gets US FDA Approval for Phase I Study

Antengene Corp., Ltd (HKG: 6996) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its first-in-class CD24 monoclonal antibody (mAb), ATG-031. The Phase I PERFORM study is designed to assess the safety, tolerability, pharmacological properties, immunogenicity, and preliminary efficacy of the drug in patients with advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL), and to determine the dosage for further Phase II studies.

ATG-031: A Novel Approach to Targeting Tumor Microenvironment
ATG-031 is the world’s first CD24 mAb to reach the clinical stages, offering a unique mechanism of action. It is capable of blocking the “don’t eat me” signal in the tumor microenvironment (TME) by blocking the interaction between CD24 and the Siglec-10 receptor expressed by tumor-associated macrophages (TAM) through high-affinity binding with CD24 on the tumor cell surface. This action strengthens the phagocytosis of tumor cells mediated by macrophages and promotes the infiltration of killer T cells in the TME.

Advantages of Targeting CD24 Over CD47
Compared to another “don’t eat me” target, CD47, CD24 has a more limited distribution in healthy tissues and higher expression in tumor tissue. Importantly, CD24 is not expressed on human red blood cells, which suggests that CD24-targeted therapy may be less toxic and offer a larger safety window. This makes ATG-031 a promising candidate for cancer treatment, with the potential to improve patient outcomes and reduce side effects.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry