{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T10:02:56Z","timestamp":1791021776939,"version":"4.1.0"},"reference-count":45,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,3,13]],"date-time":"2025-03-13T00:00:00Z","timestamp":1741824000000},"content-version":"unspecified","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Cancer Research UK City of London Centre","award":["C7893\/A31530"],"award-info":[{"award-number":["C7893\/A31530"]}]},{"name":"Worldwide Cancer Research","award":["24-0087"],"award-info":[{"award-number":["24-0087"]}]},{"name":"Breast Cancer Now","award":["147; KCL-BCN-Q3"],"award-info":[{"award-number":["147; KCL-BCN-Q3"]}]},{"name":"Epsilogen Ltd","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"DOI":"10.13039\/501100000296","name":"British Skin Foundation","doi-asserted-by":"publisher","award":["006\/R\/22"],"award-info":[{"award-number":["006\/R\/22"]}],"id":[{"id":"10.13039\/501100000296","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MR\/N013700\/1; MR\/V049445\/1; MR\/R015643\/1"],"award-info":[{"award-number":["MR\/N013700\/1; MR\/V049445\/1; MR\/R015643\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2025,1,15]]},"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Anti-human epidermal growth factor receptor 2 (HER2) IgG1-based antibody therapies significantly improve cancer prognosis, yet intrinsic or acquired resistance to fragment antigen-binding (Fab)-mediated direct effects commonly occurs. Most resistant tumors retain antigen expression and therefore remain potentially targetable with anti-HER2 therapies that promote immune-mediated responses. Tumor-antigen-specific IgE class antibodies can mediate powerful immune cell-mediated effects against different cancers and have been shown to activate IgE Fc receptor-expressing monocytes. We previously reported the engineering of a trastuzumab-equivalent anti-HER2 IgE antibody and showed early evidence of Fc-mediated cancer cell-targeting effects. In the present study, we evaluated the anti-tumoral functions of two anti-HER2 IgEs, trastuzumab and pertuzumab IgE.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In vitro functionality of the two anti-HER2 antibodies was assessed by HER2 phosphorylation and ligand-independent viability assays, as well as basophil (RBL-SX38) degranulation, antibody-dependent cellular cytotoxicity\/antibody-dependent cellular phagocytosis(ADCC\/ADCP) assays and primary monocyte stimulation assays. The potential to trigger a hypersensitivity type I reaction was investigated using the basophil activation test (BAT). anti-tumoral efficacy was assessed in two humanized HER2+, trastuzumab-resistant models in vivo. Changes in the tumor microenvironment were assessed by flow cytometry or bulk RNA sequencing.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We demonstrate the anti-tumoral and immunostimulatory functions of two anti-HER2 IgEs derived from variable region sequences of the clinically available trastuzumab and pertuzumab IgG1 antibodies. IgE engagement of monocytes via the Fc region induced tumor cell cytotoxicity and a pro-inflammatory shift with upregulation of immune-stimulatory CD40, CD80 and CD86, and downregulation of scavenger CD163, cell surface molecules. This was accompanied by enhanced pro-inflammatory tumor necrosis factor (TNF)-\u03b1, interleukin (IL)-6, IL-1\u03b2 cytokine production. The absence of basophil activation by anti-HER2 IgEs ex vivo in whole blood points to potentially safe administration in humans. In two trastuzumab-resistant HER2+ tumor xenograft models in immunodeficient mice reconstituted with human immune cells, the trastuzumab-equivalent anti-HER2 IgE restricted tumor growth. Treatment was associated with enriched classical (CD14<jats:sup>+<\/jats:sup>CD16<jats:sup>\u2013<\/jats:sup>) monocyte and lower alternatively-activated (CD163<jats:sup>+<\/jats:sup>CD206<jats:sup>+<\/jats:sup>) macrophage infiltration, and higher densities of activated CD4<jats:sup>+<\/jats:sup> (CD127<jats:sup>lo<\/jats:sup>CD25<jats:sup>hi<\/jats:sup>) T cells and favorable effector T cell(Teff) to regulatory T cell (Treg) ratios in tumors.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Collectively, anti-HER2 IgE maintains Fab-mediated antitumor activity, induces Fc-mediated effects against HER2-expressing tumor cells, and stimulates remodeling of the immune microenvironment in tumors to promote pro-inflammatory cell phenotypes which could translate to improved outcomes for patients.<\/jats:p>\n               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