Antennova Completes First Dosing Cohort for Anti-CD24 mAb, ATN-031, in the Phase I PERFORM Study

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• ATN-031 (also known as ATG-031), is the first anti-CD24 antibody to advance to the clinic in oncology in the United States
• The Phase I PERFORM trial, ongoing at four major U.S. cancer centers, is evaluating the safety and preliminary efficacy of ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL)

DOYLESTOWN, Pa., March 20, 2024 /PRNewswire/ -- Antennova, a clinical-stage biotech company focused on oncology today announced completion of the first dosing cohort in the Phase I study for the anti-CD24 antibody, ATN-031 (also known as ATG-031). The dose escalation trial is evaluating ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL), (NCT06028373). The PERFORM trial is being conducted at four cancer centers in the U.S., led by The University of Texas MD Anderson Cancer Center.

A total of five late stage cancer patients have been enrolled based on the Bayesian Optimal Interval (BOIN) design of the trial in the first dosing cohort. To date, no dose-limiting toxicities (DLTs) have been reported among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy).

"Introducing the first anti-CD24 program for late stage cancer patients in the U.S. is a very important milestone for Antennova. We are especially grateful to the participation in the study by our patients and study centers, and encouraged to observe early clinical activity in this heavily pre-treated patient population based on clinical evaluation and translational data. We are working closely with study sites and investigators at MD Anderson, the University of California, San Francisco, the University of Colorado, and Yale University Cancer Center and look forward to providing periodic updates and presentations at major international medical conferences throughout the study." commented by Jay Mei, M.D., Ph. D., Founder and Chairman of the Board.

The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding/escalation study of ATN-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATN-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 ATN-031.

About ATN-031 

ATN-031 is a first-in-class humanized anti-CD24 monoclonal antibody which inhibits the "don't eat me" signal while stimulating the "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 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 "don't eat me" target, CD24, has a more markedly restricted distribution in normal tissues and higher expression in cancerous tissues, especially solid tumors. Importantly, CD24 is differentiated from CD47 because it is not expressed on human red blood cells, allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity.

CD24 acts as a novel innate immune checkpoint, orchestrating immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10), expressed on tumor-associated macrophages (TAMs). Preclinical data presented at the American Association for Cancer Research Annual Meeting in 2023 (AACR 2023) and the Society for Immunotherapy in Cancer Annual Meeting in 2022 (SITC 2022) demonstrated that ATN-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATN-31 induces efficient phagocytosis with a picomolar EC50 and stimulates the pro-inflammatory cytokines production by macrophages.

About Antennova

Antennova, a Delaware corporation and a subsidiary of Antengene (HKEX: 6996), is a clinical-stage biotech company specialized in developing innovative therapeutics that re-educate the tumor microenvironment, enhancing the effectiveness of standard therapies and reversing checkpoint inhibitor (CPI) resistance, as well as targeting "cold tumors" that are not responsive to the current CPI therapies. Antennova has achieved significant milestones which include advancing and developing 4 clinical stage programs: ATN-031: anti-CD24 monoclonal antibody; ATN-037: CD73 small molecule inhibitor; ATN-022: Claudin 18.2 ADC; and ATN-101: anti-PD-L1/4-1BB bispecific antibody. The U.S. Food and Drug Administration (FDA) awarded an Orphan Drug Designation to ATN-101, for pancreatic cancer; and to ATN-022, for gastric and pancreatic cancers.

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