Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein

Background The administration of recombinant interleukin 2 (IL-2) in oncology is frequently hampered by dose-limiting toxicities, including potentially lethal vascular leak syndrome. Antibody-IL-2 fusion proteins capable of preferential tumor localization have shown encouraging signs of activity in...

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Main Authors: Francesco Prisco, Dario Neri, Emanuele Puca, Eleonora Prodi, Cornelia Halin, Giulia Rotta, Ettore Gilardoni, Frauke Seehusen, Matilde Bocci, Claudia Comacchio, Sheila Dakhel Plaza
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/13/5/e010831.full
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author Francesco Prisco
Dario Neri
Emanuele Puca
Eleonora Prodi
Cornelia Halin
Giulia Rotta
Ettore Gilardoni
Frauke Seehusen
Matilde Bocci
Claudia Comacchio
Sheila Dakhel Plaza
author_facet Francesco Prisco
Dario Neri
Emanuele Puca
Eleonora Prodi
Cornelia Halin
Giulia Rotta
Ettore Gilardoni
Frauke Seehusen
Matilde Bocci
Claudia Comacchio
Sheila Dakhel Plaza
author_sort Francesco Prisco
collection DOAJ
description Background The administration of recombinant interleukin 2 (IL-2) in oncology is frequently hampered by dose-limiting toxicities, including potentially lethal vascular leak syndrome. Antibody-IL-2 fusion proteins capable of preferential tumor localization have shown encouraging signs of activity in clinical trials; however, they typically cause side effects shortly after intravenous administration, which may limit escalation to curative doses. There is an urgent need to engineer IL-2 products with “activity-on-demand” able to mask on-target off-tumor IL-2 activity without compromising therapeutic efficacy.Methods To design IL-2 biopharmaceuticals with “activity-on-demand”, which would be non-toxic on administration but regain activity at the tumor site, we explored the therapeutic potential of the co-administration of signaling inhibitors with matched pharmacokinetic properties. In this work, we used the tumor-homing F8-IL2 fusion protein, specific to a splice variant of fibronectin, and masked off-tumor toxicity by co-administration of upadacitinib, which rapidly clears from circulation. Vascular leak syndrome was monitored by histopathological analysis, the extent of peripheral edema, and cytokine levels. Immune profiling of the tumors and secondary lymphoid organs was performed by flow cytometry.Results In immunocompetent tumor-bearing mice, the combinatorial treatment significantly improved tolerability without any detectable loss of therapeutic activity, protecting the mice from body weight loss, uncontrolled systemic cytokine release, and severe vascular leak syndrome manifestations, including peripheral edema. F8-IL2 efficiently controlled tumor growth and retained its immunological activity within the neoplastic mass, as evidenced by the massive natural killer and cytotoxic T-cell infiltrates.Conclusions This study suggests that combinatorial treatments enable the administration of potentially curative doses of targeted IL-2 products while sparing healthy organs from life-threatening toxicities.
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spelling doaj-art-e24f8db03db344669c98d996bfb078e02025-08-20T03:09:39ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-05-0113510.1136/jitc-2024-010831Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion proteinFrancesco Prisco0Dario Neri1Emanuele Puca2Eleonora Prodi3Cornelia Halin4Giulia Rotta5Ettore Gilardoni6Frauke Seehusen7Matilde Bocci8Claudia Comacchio9Sheila Dakhel Plaza103 Laboratory for Animal Model Pathology, Institute of Veterinary Pathology, University of Zurich, Zurich, Switzerland1 Philochem AG, Otelfingen, Switzerland1 Philochem AG, Otelfingen, Switzerland1 Philochem AG, Otelfingen, Switzerland6 Institute of Pharmaceutical Sciences, ETH Zurich, Zurich, Switzerland2 Department of Cellular, Computational and Integrative Biology, University of Trento, Trento, Italy1 Philochem AG, Otelfingen, Switzerland3 Laboratory for Animal Model Pathology, Institute of Veterinary Pathology, University of Zurich, Zurich, Switzerland1 Philochem AG, Otelfingen, Switzerland1 Philochem AG, Otelfingen, Switzerland1 Philochem AG, Otelfingen, SwitzerlandBackground The administration of recombinant interleukin 2 (IL-2) in oncology is frequently hampered by dose-limiting toxicities, including potentially lethal vascular leak syndrome. Antibody-IL-2 fusion proteins capable of preferential tumor localization have shown encouraging signs of activity in clinical trials; however, they typically cause side effects shortly after intravenous administration, which may limit escalation to curative doses. There is an urgent need to engineer IL-2 products with “activity-on-demand” able to mask on-target off-tumor IL-2 activity without compromising therapeutic efficacy.Methods To design IL-2 biopharmaceuticals with “activity-on-demand”, which would be non-toxic on administration but regain activity at the tumor site, we explored the therapeutic potential of the co-administration of signaling inhibitors with matched pharmacokinetic properties. In this work, we used the tumor-homing F8-IL2 fusion protein, specific to a splice variant of fibronectin, and masked off-tumor toxicity by co-administration of upadacitinib, which rapidly clears from circulation. Vascular leak syndrome was monitored by histopathological analysis, the extent of peripheral edema, and cytokine levels. Immune profiling of the tumors and secondary lymphoid organs was performed by flow cytometry.Results In immunocompetent tumor-bearing mice, the combinatorial treatment significantly improved tolerability without any detectable loss of therapeutic activity, protecting the mice from body weight loss, uncontrolled systemic cytokine release, and severe vascular leak syndrome manifestations, including peripheral edema. F8-IL2 efficiently controlled tumor growth and retained its immunological activity within the neoplastic mass, as evidenced by the massive natural killer and cytotoxic T-cell infiltrates.Conclusions This study suggests that combinatorial treatments enable the administration of potentially curative doses of targeted IL-2 products while sparing healthy organs from life-threatening toxicities.https://jitc.bmj.com/content/13/5/e010831.full
spellingShingle Francesco Prisco
Dario Neri
Emanuele Puca
Eleonora Prodi
Cornelia Halin
Giulia Rotta
Ettore Gilardoni
Frauke Seehusen
Matilde Bocci
Claudia Comacchio
Sheila Dakhel Plaza
Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
Journal for ImmunoTherapy of Cancer
title Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
title_full Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
title_fullStr Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
title_full_unstemmed Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
title_short Combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor-targeted IL-2 fusion protein
title_sort combinatorial treatment with upadacitinib abrogates systemic toxicity of a tumor targeted il 2 fusion protein
url https://jitc.bmj.com/content/13/5/e010831.full
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