{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:38:07Z","timestamp":1792600687644,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:00:00Z","timestamp":1791504000000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Chronic Pseudomonas aeruginosa airway colonization in bronchiectasis (BE) is associated with frequent exacerbations. Bispecific antibody AZD0292, targeting P. aeruginosa Psl and PcrV, was engineered from gremubamab with a Fc N3Y substitution to extend half-life and is being developed to reduce exacerbations in BE with chronic P. aeruginosa colonization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Preclinical studies assessed opsonophagocytic killing and anticytotoxicity assays, repeat-dose toxicology with ex vivo pharmacodynamic analyses in cynomolgus monkeys, and pharmacokinetics in human FcRn transgenic mice. In phase 1, healthy adults were randomized to receive a single dose of AZD0292 (n = 24) or placebo (n = 8) in 4 cohorts (100\u20132000\u2005mg) and followed for 61 days or 161 days in cohort 4. End points included safety, pharmacokinetics, immunogenicity, and exploratory cytokine\/complement assessments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>AZD0292 demonstrated comparable functional activity to gremubamab, an approximately 55% lower clearance in transgenic mice, and retained anti-P. aeruginosa activity in cynomolgus monkey serum after repeated dosing. In phase 1, AZD0292 was generally well tolerated. Mild\/moderate infusion-related reactions occurred only at higher doses and were managed with routine clinical measures. Transient cytokine increases were observed after dosing, with no meaningful complement activation. Pharmacokinetics were approximately dose-dependent but slightly less than dose-proportional across 100\u20132000\u2005mg. Geometric mean half-life ranged from 24 to 47 days, although estimates are provisional given small cohort sizes and limited follow-up. No treatment-emergent antidrug antibodies were detected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results support further clinical development of AZD0292 for reduction of exacerbations in BE with chronic P. aeruginosa colonization, with pharmacokinetics requiring confirmation in the target patient population.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. NCT06311760.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag500","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T11:51:55Z","timestamp":1791373915000},"source":"Crossref","is-referenced-by-count":0,"title":["Translational and Phase 1 Evaluation of AZD0292, a Novel, Half-life-Extended Antipseudomonal Psl-PcrV Bispecific Monoclonal Antibody"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5879-6329","authenticated-orcid":false,"given":"Engin","family":"L","sequence":"first","affiliation":[{"name":"Early Clinical Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca , Gothenburg ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3697-466X","authenticated-orcid":false,"given":"Camille","family":"Riff","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Quantitative Pharmacology, Respiratory and 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