This clinical study, codenamed the PERFORM trial and led by MD Anderson, will be conducted in patients with advanced solid tumors or B-NHL.
The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031.
Dr.
'Through committed work and unrelenting innovation, our R&D organization successfully advanced the ATG-031 program to the clinical stage in just three years, an achievement that has truly made us proud,' said Dr.
About ATG-031
ATG-031 is a first-in-class humanized CD24 monoclonal antibody which inhibits the 'don't eat me' signal and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing 'don't eat me' surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 (cluster of differentiation 24) is a prominent 'don't eat me' signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another well-known 'don't eat me' target, CD24 has a more restricted distribution in normal tissue and higher expression in cancerous tissue. In addition unlike CD47 CD24 is not expressed on human red blood cells allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity as a CD24-targeted therapy.
As a novel innate immune checkpoint, CD24 orchestrates immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10) expresses on tumor-associated macrophages (TAMs). Preclinical data presented in 2023 at the
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