{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T22:38:28Z","timestamp":1788907108556,"version":"build-2803163510"},"reference-count":47,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2022,7,11]],"date-time":"2022-07-11T00:00:00Z","timestamp":1657497600000},"content-version":"unspecified","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Ascendis Pharma"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2022,6,21]]},"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Recombinant interleukin-2 (IL-2, aldesleukin) is an approved cancer immunotherapy but causes severe toxicities including cytokine storm and vascular leak syndrome (VLS). IL-2 promotes antitumor function of IL-2R\u03b2\/\u03b3<jats:sup>+<\/jats:sup> natural killer (NK) cells and CD8<jats:sup>+<\/jats:sup>, CD4<jats:sup>+<\/jats:sup> and gamma delta (\u03b3\u03b4) T cells. However, IL-2 also potently activates immunosuppressive IL-2R\u03b1<jats:sup>+<\/jats:sup> regulatory T cells (Tregs) and IL-2R\u03b1<jats:sup>+<\/jats:sup> eosinophils and endothelial cells, which may promote VLS. Aldesleukin is rapidly cleared requiring frequent dosing, resulting in high C<jats:sub>max<\/jats:sub> likely potentiating toxicity. Thus, IL-2 cancer immunotherapy has two critical drawbacks: potent activation of undesired IL-2R\u03b1<jats:sup>+<\/jats:sup> cells and suboptimal pharmacokinetics with high C<jats:sub>max<\/jats:sub> and short half-life.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>TransCon IL-2 \u03b2\/\u03b3 was designed to optimally address these drawbacks. To abolish IL-2R\u03b1 binding yet retain strong IL-2R\u03b2\/\u03b3 activity, IL-2 \u03b2\/\u03b3 was created by permanently attaching a small methoxy polyethylene glycol (mPEG) moiety in the IL-2R\u03b1 binding site. To improve pharmacokinetics, IL-2 \u03b2\/\u03b3 was transiently attached to a 40\u2009kDa mPEG carrier via a TransCon (transient conjugation) linker creating a prodrug, TransCon IL-2 \u03b2\/\u03b3, with sustained release of IL-2 \u03b2\/\u03b3. IL-2 \u03b2\/\u03b3 was characterized in binding and primary cell assays while TransCon IL-2 \u03b2\/\u03b3 was studied in tumor-bearing mice and cynomolgus monkeys.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>IL-2 \u03b2\/\u03b3 demonstrated selective and potent human IL-2R\u03b2\/\u03b3 binding and activation without IL-2R\u03b1 interactions. TransCon IL-2 \u03b2\/\u03b3 showed slow-release pharmacokinetics with a low C<jats:sub>max<\/jats:sub> and a long (&gt;30\u2009hours) effective half-life for IL-2 \u03b2\/\u03b3 in monkeys. In mouse tumor models, TransCon IL-2 \u03b2\/\u03b3 promoted CD8<jats:sup>+<\/jats:sup> T cell and NK cell activation and antitumor activity. In monkeys, TransCon IL-2 \u03b2\/\u03b3 induced robust activation and expansion of CD8<jats:sup>+<\/jats:sup> T cells, NK cells and \u03b3\u03b4 T cells, relative to CD4<jats:sup>+<\/jats:sup> T cells, Tregs and eosinophils, with no evidence of cytokine storm or VLS. Similarly, IL-2 \u03b2\/\u03b3 enhanced proliferation and cytotoxicity of primary human CD8<jats:sup>+<\/jats:sup> T cells, NK cells and \u03b3\u03b4 T cells.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Summary<\/jats:title>\n                  <jats:p>TransCon IL-2 \u03b2\/\u03b3 is a novel long-acting prodrug with sustained release of an IL-2R\u03b2\/\u03b3-selective IL-2. It has remarkable and durable pharmacodynamic effects in monkeys and potential for improved clinical efficacy and tolerability compared with aldesleukin. TransCon IL-2 \u03b2\/\u03b3 is currently being evaluated in a Phase 1\/2 clinical trial (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05081609\">NCT05081609<\/jats:ext-link>).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2022-004991","type":"journal-article","created":{"date-parts":[[2022,7,11]],"date-time":"2022-07-11T11:46:28Z","timestamp":1657539988000},"page":"e004991","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":38,"title":["TransCon IL-2 \u03b2\/\u03b3: a novel long-acting prodrug with sustained release of an IL-2R\u03b2\/\u03b3-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct05081609","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05081609","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9856-7675","authenticated-orcid":false,"given":"David B","family":"Rosen","sequence":"first","affiliation":[{"name":"Ascendis Pharma Inc, Redwood City, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne M\u00e5nsson","family":"Kvarnhammar","sequence":"additional","affiliation":[{"name":"Ascendis Pharma A\/S, Hellerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Burkhardt","family":"Laufer","sequence":"additional","affiliation":[{"name":"Ascendis Pharma GmbH, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Knappe","sequence":"additional","affiliation":[{"name":"Ascendis Pharma GmbH, 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