{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T19:48:18Z","timestamp":1782935298343,"version":"3.54.5"},"reference-count":126,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T00:00:00Z","timestamp":1749081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>Hemolytic uremic syndrome (HUS) is a thrombotic microangiopathy characterized by microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury (AKI). Shiga toxin (Stx)-producing Escherichia coli-associated HUS (STEC-HUS) is one of the leading causes of AKI in children. Approximately 1.5 to 3% of children die during the acute phase, and about 30% experience long-term renal sequelae. Argentina has the highest incidence of STEC-HUS globally. Given the prominent role of Stx in its pathophysiology, STEC-HUS is considered more of a toxemia than a bacterial disease. Stx transport occurs before and after the STEC-HUS onset, allowing for the distinction between an early toxemia phase and an advanced toxemia phase. In this review, we present our efforts to develop INM004, an anti-Stx treatment aimed at ameliorating or preventing the clinical consequences of STEC-HUS. We describe the protein engineering that facilitated this development and the clinical path to demonstrate the safety and efficacy of INM004. This immunotherapy could represent a new step in the treatment of STEC-HUS, which could potentially prevent long-term damage. If phase 3 trials are successful, earlier and broader use of INM004 is envisioned. We also discuss the potential impact of INM004 therapy, targeted vaccination strategies, and new diagnostic tools for this disease.<\/jats:p>","DOI":"10.3390\/toxins17060282","type":"journal-article","created":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T03:58:52Z","timestamp":1749095932000},"page":"282","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["INM004: Polyclonal Neutralizing Antibodies Against Shiga Toxin as a Treatment for Hemolytic Uremic Syndrome"],"prefix":"10.3390","volume":"17","author":[{"given":"Marta","family":"Rivas","sequence":"first","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana","family":"Pichel","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanesa","family":"Zylberman","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"},{"name":"Consejo Nacional de Investigaciones Cientificas y Tecnicas (CONICET), Godoy Cruz 2290, Ciudad Autonoma de Buenos Aires 1425, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3095-1312","authenticated-orcid":false,"given":"Mariana","family":"Colonna","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Valerio","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Massa","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romina","family":"Pardo","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9s E.","family":"Ciocchini","sequence":"additional","affiliation":[{"name":"Consejo Nacional de Investigaciones Cientificas y Tecnicas (CONICET), Godoy Cruz 2290, Ciudad Autonoma de Buenos Aires 1425, Argentina"},{"name":"Instituto de Investigaciones Biotecnol\u00f3gicas, Universidad Nacional de San Mart\u00edn (UNSAM), Escuela de Bio y Nanotecnolog\u00edas, UNSAM Campus Miguelete, 25 de Mayo y Francia, San Mart\u00edn 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santiago","family":"Sanguineti","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Roubicek","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linus","family":"Spatz","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando Alberto","family":"Goldbaum","sequence":"additional","affiliation":[{"name":"Inmunova S.A., Av. 25 de Mayo 1021, San Mart\u00edn, Buenos Aires 1650, Argentina"},{"name":"Consejo Nacional de Investigaciones Cientificas y Tecnicas (CONICET), Godoy Cruz 2290, Ciudad Autonoma de Buenos Aires 1425, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1007\/s00281-014-0416-x","article-title":"Hemolytic uremic syndrome","volume":"36","author":"Mele","year":"2014","journal-title":"Semin. 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