Pharma Focus Asia

Antengene Announces Clearance of U.S. IND for the Phase I Trial

Thursday, May 18, 2023

Antengene Corporation announced that the Investigational New Drug (IND) for a Phase I study of the first-in-class anti-CD24 monoclonal antibody ATG-031 has received clearance from the U.S. Food and Drug Administration (FDA).

ATG-031 is a first-in-class humanised anti-CD24 monoclonal antibody which inhibits the “don’t eat me” signal in the tumour microenvironment (TME). ATG-031 was designed to specifically bind with the CD24 expressed on cancer cells with high affinity and block the interaction between CD24 and the Siglec-10 receptor expressed on the surface of tumour associated macrophages (TAMs), to enhance the macrophage-mediated phagocytosis of cancer cells and promote cytotoxic T-cell function in the tumour microenvironment.

The PERFORM trial is a first-in-human, multi-centre, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumours or B-NHL. The primary objective of the study is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and to determine the appropriate dose for Phase II studies.

ATG-031 is the world’s first anti-CD24 antibody to be advanced to the clinic in oncology and Antengene’s third drug candidate cleared to enter clinical studies in the U.S. The potential role of ATG-031 is supported by robust preclinical data that showed potent single agent in vivo efficacy and synergistic effects with chemotherapy or checkpoint inhibitors (CPIs).

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