AACR Annual Meeting 2022

Abstract Introduction: Tumor necrosis factor-alpha (TNFα) is a pleiotropic cytokine with known antitumor activity, produced mainly by activated immune cells. Cancer cells neutralize TNFα by shedding soluble TNF receptors 1&2 (sTNF-Rs), which act as TNFα-binding decoys, promoting cancer cell proliferation, survival, and chemoresistance. Immunopheresis® employs therapeutic apheresis with the selective immunoadsorption LW-02 column (LW-02) for treating solid malignancies. LW-02-based Immunopheresis (granted FDA Breakthrough Device Designation and a CE Mark for mTNBC) selectively removes sTNF-Rs from plasma, permitting TNFα to bind to membrane-bound TNF-Rs, activating intracellular death pathways, and also modulate T-cell-mediated immune activity. Part A data of our phase I/II clinical trial in metastatic, chemorefractory, triple-negative breast cancer (mTNBC) patients (NCT04004910) confirmed that LW-02-based Immunopheresis monotherapy is safe and well-tolerated, with signs of disease stabilization (SD) in patients treated >4 weeks. Here we present interim data on the safety and preliminary efficacy of LW-02 Immunopheresis combined with chemotherapy.