Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy

Background Human papillomavirus (HPV)-associated malignancies continue to present a major health concern despite the development of prophylactic vaccines. Standard therapies offer limited benefit to patients with advanced-stage disease. Despite improved outcomes with programmed cell death protein-1...

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Main Authors: Jeffrey Schlom, James L Gulley, Caroline Jochems, Sofia R Gameiro, Wiem Lassoued, Daniel Burnett, Lisa K Poppe, Nicholas Roller, Miriam Marlene Medina-Enríquez, Katherine E Lothstein, Asma S Khelifa, Masaya Miyamoto
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/e011074.full
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author Jeffrey Schlom
James L Gulley
Caroline Jochems
Sofia R Gameiro
Wiem Lassoued
Daniel Burnett
Lisa K Poppe
Nicholas Roller
Miriam Marlene Medina-Enríquez
Katherine E Lothstein
Asma S Khelifa
Masaya Miyamoto
author_facet Jeffrey Schlom
James L Gulley
Caroline Jochems
Sofia R Gameiro
Wiem Lassoued
Daniel Burnett
Lisa K Poppe
Nicholas Roller
Miriam Marlene Medina-Enríquez
Katherine E Lothstein
Asma S Khelifa
Masaya Miyamoto
author_sort Jeffrey Schlom
collection DOAJ
description Background Human papillomavirus (HPV)-associated malignancies continue to present a major health concern despite the development of prophylactic vaccines. Standard therapies offer limited benefit to patients with advanced-stage disease. Despite improved outcomes with programmed cell death protein-1 (PD-1) targeted therapies, treatment resistance and modest response rates highlight a significant unmet need to develop novel therapies for these patients. PDS0101 (designated HPV vaccine) is a liposomal nanoparticle HPV16-specific therapeutic vaccine that has been shown to generate strong HPV-specific responses in preclinical and clinical studies. Here we assess the efficacy of this HPV vaccine in combination with the tumor-targeting immunocytokine NHS-IL12 (PDS01ADC), plus either αPD-1 or the class I histone deacetylase inhibitor Entinostat.Methods Mice bearing HPV16+, αPD-1 refractory TC-1 and mEER tumors were treated with HPV vaccine, NHS-IL12, and either αPD-1 or Entinostat to determine antitumor efficacy and survival benefits. A comprehensive analysis of the tumor microenvironment was performed using flow cytometry, multiplex immunofluorescence, chemokine and cytokine assessment, and single-cell RNA sequencing with T-cell receptor (TCR) enrichment.Results Combination of HPV vaccine and NHS-IL12 with either Entinostat or αPD-1 yielded significant antitumor activity and prolonged survival in αPD-1 refractory models of HPV16+ cancer, with superior activity employing Entinostat versus αPD-1 combination. Entinostat triple therapy increased overall and HPV16-specific tumor CD8+ T-cell infiltration with heightened cytotoxicity. TCR sequencing revealed a CD8+ T-cell clone unique to vaccine-treated cohorts, which displayed an enriched cytotoxic transcriptional profile with triple therapy. These effects were paralleled by strong differentiation of tumor-associated macrophages (TAMs) towards pro-inflammatory, antitumor M1-like cell states. Single-cell transcriptomic analysis indicated all three agents were required for highest modulation of both CD8+ T cells and TAMs conducive to tumor control. A biomarker signature reflecting the preclinical findings was found to be associated with improved survival in patients with HPV-associated malignancies.Conclusion Together, these findings provide a rationale for the combination of HPV vaccine, NHS-IL12, and Entinostat in the clinical setting for patients with HPV16-associated malignancies.
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spelling doaj-art-a191095d8ba04fd39d1bd7b0b6d77d432025-08-20T03:11:51ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-05-0113510.1136/jitc-2024-011074Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapyJeffrey Schlom0James L Gulley1Caroline Jochems2Sofia R Gameiro3Wiem Lassoued4Daniel Burnett5Lisa K Poppe6Nicholas Roller7Miriam Marlene Medina-Enríquez8Katherine E Lothstein9Asma S Khelifa10Masaya Miyamoto11Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USAAff1 0000 0004 1936 8075grid.48336.3aLaboratory of Tumor Immunology and Biology, Center for Cancer ResearchNational Cancer Institute, National Institutes of Health 10 Center Drive, Room 8B09 Bethesda MD USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USACenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USABackground Human papillomavirus (HPV)-associated malignancies continue to present a major health concern despite the development of prophylactic vaccines. Standard therapies offer limited benefit to patients with advanced-stage disease. Despite improved outcomes with programmed cell death protein-1 (PD-1) targeted therapies, treatment resistance and modest response rates highlight a significant unmet need to develop novel therapies for these patients. PDS0101 (designated HPV vaccine) is a liposomal nanoparticle HPV16-specific therapeutic vaccine that has been shown to generate strong HPV-specific responses in preclinical and clinical studies. Here we assess the efficacy of this HPV vaccine in combination with the tumor-targeting immunocytokine NHS-IL12 (PDS01ADC), plus either αPD-1 or the class I histone deacetylase inhibitor Entinostat.Methods Mice bearing HPV16+, αPD-1 refractory TC-1 and mEER tumors were treated with HPV vaccine, NHS-IL12, and either αPD-1 or Entinostat to determine antitumor efficacy and survival benefits. A comprehensive analysis of the tumor microenvironment was performed using flow cytometry, multiplex immunofluorescence, chemokine and cytokine assessment, and single-cell RNA sequencing with T-cell receptor (TCR) enrichment.Results Combination of HPV vaccine and NHS-IL12 with either Entinostat or αPD-1 yielded significant antitumor activity and prolonged survival in αPD-1 refractory models of HPV16+ cancer, with superior activity employing Entinostat versus αPD-1 combination. Entinostat triple therapy increased overall and HPV16-specific tumor CD8+ T-cell infiltration with heightened cytotoxicity. TCR sequencing revealed a CD8+ T-cell clone unique to vaccine-treated cohorts, which displayed an enriched cytotoxic transcriptional profile with triple therapy. These effects were paralleled by strong differentiation of tumor-associated macrophages (TAMs) towards pro-inflammatory, antitumor M1-like cell states. Single-cell transcriptomic analysis indicated all three agents were required for highest modulation of both CD8+ T cells and TAMs conducive to tumor control. A biomarker signature reflecting the preclinical findings was found to be associated with improved survival in patients with HPV-associated malignancies.Conclusion Together, these findings provide a rationale for the combination of HPV vaccine, NHS-IL12, and Entinostat in the clinical setting for patients with HPV16-associated malignancies.https://jitc.bmj.com/content/13/5/e011074.full
spellingShingle Jeffrey Schlom
James L Gulley
Caroline Jochems
Sofia R Gameiro
Wiem Lassoued
Daniel Burnett
Lisa K Poppe
Nicholas Roller
Miriam Marlene Medina-Enríquez
Katherine E Lothstein
Asma S Khelifa
Masaya Miyamoto
Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
Journal for ImmunoTherapy of Cancer
title Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
title_full Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
title_fullStr Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
title_full_unstemmed Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
title_short Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy
title_sort combination of hdac inhibition and cytokine enhances therapeutic hpv vaccine therapy
url https://jitc.bmj.com/content/13/5/e011074.full
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