ATN-031

CD24 is a promising target in EGFR-mutated lung cancers, potentially enhancing efficacy of third-generation EGFR-TKIs.

Stochastic bioconjugation methods were used to append deferoxamine (DFO) to a trio of monoclonal antibodies: trastuzumab (αHER2), AR9.6 (αMUC16), and ATG-031 (αCD24). [89Zr]Zr-DFO-ATG-031 and [89Zr]Zr-DFO-trastuzumab exhibit significant promise for immuno-PET imaging of endometrial cancer. These probes may prove beneficial in the clinic, not only for the noninvasive staging and monitoring of the disease but also as companion imaging agents for HER2- and CD24-targeted therapeutics.

P1, N=80, Recruiting, Antengene Biologics Limited | N=48 --> 80 | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Dec 2025 --> Dec 2026

P1, N=48, Recruiting, Antengene Biologics Limited | Not yet recruiting --> Recruiting

Conclusions In preclinical studies, ATG-031 demonstrates potent antitumor activity, excellent safety and PK properties, which supports its further development in clinical trials. A phase I, multicentre, dose-escalating clinical trial is being developed to evaluate ATG-031 in patients with solid tumors and hematologic malignancies.

ATG-031, a first-in-class anti-CD24 antibody, demonstrated potent anti-tumor activity in vivo, re-polarizing M2-like TAM to anti-tumor M1 subtype in the TME and induced systemic anti-tumor immunity. A clinical study to investigate the safety and efficacy of ATG-031 in cancer patients is being developed.

It demonstrates potent in vivo anti-tumor tumor efficacy, suggesting promising therapeutic strategies against a broad range of solid tumor or hematological malignancies, which warrants further clinical investigation. A clinical study to investigate the safety and efficacy of ATG-031 in cancer patients is being developed.