{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T22:06:01Z","timestamp":1791324361049,"version":"4.3.1"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Topas Therapeutics GmbH"},{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pemphigus vulgaris (PV) is a CD4+ T-cell-dependent autoantibody-mediated blistering disease associated with human leucocyte antigen (HLA) class II molecules. IgG autoantibodies against the primary autoantigen desmoglein 3 (Dsg3), a desmosomal adhesion protein on epidermal keratinocytes, cause loss of epidermal cell adhesion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the clinical applicability of an innovative nanoparticle platform for the induction of immune tolerance exploiting the natural tolerance potential of liver sinusoidal endothelial cells. An open-label first-in-human study was conducted with TPM203, a mixture of four nanoparticle-coupled immunodominant Dsg3\u2005T-cell peptides.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The efficacy and mechanism of action of TPM203 were first tested in a humanized HLA-DRB1*0402-transgenic PV mouse model. In the clinical phase I trial, TPM203 was administered intravenously in patients with PV with no-to-moderate disease activity in single ascending and multiple doses (three doses of TPM203 two weeks apart). Primary endpoints included safety and tolerability. As a secondary endpoint, pharmacokinetics were assessed. Exploratory endpoints comprised changes in Dsg3-specific and bulk T- and B-cell frequencies, anti-Dsg3 IgG levels and autoantibody-induced keratinocyte dissociation. The trial was registered with EudraCT (2019-001727-12).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the PV mouse model, two administrations of TPM203 significantly reduced anti-Dsg3 IgG. On the cellular level, TPM203 led to a significant decrease in CD4+ T cells in the spleen, accompanied by increased frequencies of regulatory T (Treg) cells. In the clinical trial, the 17 patients with PV enrolled across single- and multiple-dose groups did not experience any serious or severe adverse events, or treatment-related PV worsening. Pharmacokinetics confirmed rapid TPM203 clearance from the circulation. Significant TPM203-induced modulations in bulk lymphocyte subsets included an increase in Treg cells, and reductions in T helper 17.1 and CD27+ memory B cells, when dose groups were combined for analysis. Dsg3-specific T cells were found to be significantly reduced at week 8 following single administration of TPM203. Anti-Dsg3 IgG levels trended downward in the three lower single ascending dose groups, while IgG-induced keratinocyte-dissociating capacity was significantly reduced after multiple doses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Administered for the first time in humans, TPM203 was shown to be a safe and well-tolerated nanoparticle-based therapeutic approach with the potential to promote tolerance induction in PV, justifying further clinical development in this and other autoimmune diseases.<\/jats:p>\n                    <jats:p>An author video to accompany this article is available online.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljaf311","type":"journal-article","created":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T11:46:49Z","timestamp":1754567209000},"page":"86-98","source":"Crossref","is-referenced-by-count":8,"title":["Safety, tolerability, pharmacokinetics and pharmacodynamic effects of desmoglein 3 peptide-coupled tolerizing nanoparticles in pemphigus"],"prefix":"10.1093","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6119-1870","authenticated-orcid":false,"given":"Dario","family":"Didona","sequence":"first","affiliation":[{"name":"Department of Dermatology and Allergology, Philipps-Universit\u00e4t Marburg , Marburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5807-6882","authenticated-orcid":false,"given":"Christoph","family":"Hudemann","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, Philipps-Universit\u00e4t Marburg , Marburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5178-4023","authenticated-orcid":false,"given":"Holger","family":"Garn","sequence":"additional","affiliation":[{"name":"Translational Inflammation Research Division and Core Facility for Single Cell Multiomics, Biochemical-Pharmacological Center, Philipps-Universit\u00e4t Marburg , Marburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1921-8905","authenticated-orcid":false,"given":"Daria","family":"Krzikalla","sequence":"additional","affiliation":[{"name":"Topas Therapeutics (Topas) , Hamburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4071-4748","authenticated-orcid":false,"given":"Shu-Hung","family":"Wang","sequence":"additional","affiliation":[{"name":"Topas Therapeutics (Topas) , Hamburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7964-3401","authenticated-orcid":false,"given":"Julia","family":"Hinterseher","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, Philipps-Universit\u00e4t Marburg , Marburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5331-0948","authenticated-orcid":false,"given":"Karolin","family":"Volkmann","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, Philipps-Universit\u00e4t Marburg , Marburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4792-9306","authenticated-orcid":false,"given":"Alexandra","family":"Polakova","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, Philipps-Universit\u00e4t Marburg , Marburg 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