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Primary study objectives were to determine the recommended phase 2 dose (RP2D) and to evaluate the safety and immunogenicity of JNJ-809.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 26 patients received JNJ-809 (1\u2009\u00d7\u200910<jats:sup>8<\/jats:sup> CFU (<jats:italic>n<\/jats:italic>\u2009=\u20096); 1\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> CFU (<jats:italic>n<\/jats:italic>\u2009=\u200920)). No dose-limiting toxicities were reported, and 1\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> CFU was selected as the RP2D. The most common adverse events (AEs) reported were chills (92%), pyrexia (81%), and fatigue (62%). The most frequent grade \u22653 AEs were lymphopenia (27%) and hypertension (23%). Serious AEs were reported in 27% of patients including 1 patient with grade 3 intestinal obstruction. JNJ-809 transiently induced peripheral cytokines, including interferon-\u03b3, interleukin-10, and tumor necrosis factor-\u03b1. Of the 7 patients evaluable for T cell responses at the 1\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> CFU dose, evidence of post-treatment antigenic responses were observed in 6 to the <jats:italic>Listeria<\/jats:italic> antigen listeriolysin O and in 5 to \u22651 of the 4 encoded tumor antigens. Best overall response was stable disease in 13\/25 response-evaluable patients. The study was terminated early as data collected were considered sufficient to evaluate safety and immunogenicity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>JNJ-809 has manageable safety consistent with other LADD <jats:italic>Lm<\/jats:italic>-based therapies. Limited antigen-specific immune responses were observed, which did not translate into objective clinical responses.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1038\/s41391-021-00402-8","type":"journal-article","created":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T17:02:40Z","timestamp":1626195760000},"page":"219-228","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Safety and preliminary immunogenicity of JNJ-64041809, a live-attenuated, double-deleted Listeria monocytogenes-based immunotherapy, in metastatic castration-resistant prostate cancer"],"prefix":"10.1038","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9610-3677","authenticated-orcid":false,"given":"Charles G.","family":"Drake","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell K.","family":"Pachynski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5208-7732","authenticated-orcid":false,"given":"Sumit K.","family":"Subudhi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1471-6723","authenticated-orcid":false,"given":"Douglas G.","family":"McNeel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel S.","family":"Antonarakis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd M.","family":"Bauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Lauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Brockstedt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Patricia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Wade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Zudaire","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nibedita","family":"Bandyopadhyay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dolly A.","family":"Parasrampuria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzette","family":"Girgis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary E.","family":"Mason","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland E.","family":"Knoblauch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Stone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey R.","family":"Infante","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco M.","family":"Gottardis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6428-428X","authenticated-orcid":false,"given":"Lawrence","family":"Fong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,7,13]]},"reference":[{"key":"402_CR1","doi-asserted-by":"publisher","first-page":"394","DOI":"10.3322\/caac.21492","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. 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JTO Clin Res Rep. 2021;2:100103.","journal-title":"JTO Clin Res Rep"}],"container-title":["Prostate Cancer and Prostatic Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41391-021-00402-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41391-021-00402-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41391-021-00402-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,4]],"date-time":"2022-07-04T11:15:38Z","timestamp":1656933338000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41391-021-00402-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,13]]},"references-count":40,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["402"],"URL":"https:\/\/doi.org\/10.1038\/s41391-021-00402-8","relation":{},"ISSN":["1365-7852","1476-5608"],"issn-type":[{"value":"1365-7852","type":"print"},{"value":"1476-5608","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,13]]},"assertion":[{"value":"14 December 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 May 2021","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 May 2021","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 July 2021","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"C.G.D. is a current employee of Janssen R&D and reports prior consulting or advisory role for AstraZeneca\/MedImmune, Bristol-Myers Squibb, Compugen, Roche\/Genentech, Janssen Oncology, Pfizer, Tizona Therapeutics, Inc., Potenza Therapeutics, Merck, Rubius, and Pierre Fabre; travel, accommodation, expenses from Roche\/Genentech, AACR, ASCO, Merck Sharp & Dohme, and Pfizer; patents licensed from Johns Hopkins to Bristol-Myers Squibb; stock and other ownership interests in Compugen, Tizona Therapeutics, Inc., Harpoon Therapeutics, and Kleo Pharmaceuticals; and research funding to Johns Hopkins from Bristol-Myers Squibb. R.K.P. reports consulting or advisory role for EMD Serono, Bristol-Myers Squibb, Pfizer\/EMD Serono, Sanofi, Jounce Therapeutics, Dendreon, Bayer, and Genomic Health; speakers\u2019 bureau for Dendreon, Merck, Genentech\/Roche, AstraZeneca, Sanofi, and Genomic Health; travel, accommodations, expenses from Genentech\/Roche, DAVA Oncology; and research funding from Janssen Oncology. S.K.S. reports consulting or advisory role for Amgen, Apricity Health, AstraZeneca, Bayer, Bristol-Myers Squibb, Dava Oncology, Dendreon, Exelixis, Janssen Oncology, and Polaris; travel, accommodations, expenses from AstraZeneca, Bristol-Myers Squibb, Dava Oncology, Dendreon, Parker Institute of Cancer Immunotherapy, and Society for Immunotherapy of Cancer; stock or other ownership in Apricity Health; honoraria from AstraZeneca, Bristol-Myers Squibb, Dava Oncology, Dendreon, Parker Institute of Cancer Immunotherapy, and Society for Immunotherapy of Cancer; and research funding to his institution from AstraZeneca, Bristol-Myers Squibb, and Janssen Oncology. D.G.M. reports consulting or advisory role for Madison Vaccines, Inc.; leadership role for Madison Vaccines, Inc.; travel, accommodations, expenses from Madison Vaccines, Inc., patents licensed from his institution to Madison Vaccines, Inc.; stock and other ownership interests in Madison Vaccines, Inc.; research funding to his institution from Madison Vaccines, Inc. and from Janssen, Bristol-Myers Squibb, Pfizer, Merck, and Novartis. E.S.A. reports consulting or advisory role for Sanofi, Dendreon, Medivation, Janssen Biotech, ESSA, Astellas Pharma, Merck, AstraZeneca, and Clovis Oncology; travel, accommodations, expenses from Sanofi, Dendreon, and Medivation; co-inventor of a biomarker technology that has been licensed to Qiagen; honoraria from Sanofi, Dendreon, Medivation, Janssen Biotech, ESSA, Astellas Pharma, Merck, AstraZeneca, and Clovis Oncology; research funding to his institution from Janssen Biotech, Johnson & Johnson, Sanofi, Dendreon, Aragon Pharmaceuticals, Exelixis, Millennium, Genentech, Novartis, Astellas Pharma, Tokai Pharmaceuticals, Merck, AstraZeneca, Clovis Oncology, and Constellation Pharmaceuticals. T.M.B. reports employment with Tennessee Oncology; consulting or advisory role for Guardant Health, Loxo, Pfizer, and Exelixis; consulting or advisory role for his institution for Ignyta, Moderna Therapeutics, and Pfizer; speakers\u2019 bureau for Bayer; travel, accommodations, expenses from Astellas Pharma, AstraZeneca, Celgene, Clovis Oncology, EMD Serono, Genentech, Lilly, Merck, Novartis, Pharmacyclics, and Sysmex; research funding to his institution from Daiichi Sankyo, Medpacto, Inc., Incyte, Mirati Therapeutics, MedImmune, AbbVie, AstraZeneca, Leap Therapeutics, MabVax, Stemline Therapeutics, Merck, Lilly, GlaxoSmithKline, Novartis, Pfizer, Genentech\/Roche, Deciphera, Merrimack, Immunogen, Millennium, Ignyta, Calithera Biosciences, Kolltan Pharmaceuticals, Principa Biopharma, Peleton, Immunocore, Roche, Aileron Therapeutics, Bristol-Myers Squibb, Amgen, Moderna Therapeutics, Sanofi, Boehringer Ingelheim, Astellas Pharma, Five Prime Therapeutics, Jacobio, Top Alliance BioScience, Loxo, Janssen, Clovis Oncology, Takeda, Karyopharm Therapeutics, Onyx, Phosplatin Therapeutics, Foundation Medicine, and ARMO BioSciences. P.L. and Dr. D.B. report former employment with Aduro Biotech. D.P., M.W., E.Z., N.B., D.A.P., S.G., G.E.M., R.E.K., N.S., J.R.I., and M.M.G. report employment with Janssen R&D and stock or other ownership in Johnson & Johnson. L.F. reports consulting or advisory role for Atreca, Nutcracker Therapeutics, Inc., Bolt Biotherapeutics, BioAtla, and TeneoBio and research funding to his institution from Bristol-Myers Squibb, AbbVie, Roche\/Genentech, Janssen Oncology, Merck, Bavarian Nordic, and Dendreon.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data sharing statement"}}]}}