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Review, Journal: "All for One and One for All": The Secreted Heat Shock Protein gp96-Ig Based Vaccines. (Pubmed Central) - Jan 15, 2024 In this review, we will highlight three major principles of the gp96-Ig vaccine strategy: (1) presentation of pathogenic antigens to T cells (specificity); (2) activation of innate immune responses (adjuvanticity); (3) priming of T cells to home to the epithelial compartments (mucosal immunity). In summary, we provide a paradigm for a vaccine approach that can be rapidly engineered and customized for any future pathogens that require induction of effective tissue-resident memory responses in epithelial tissues.
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Enrollment closed, Trial completion date, Combination therapy: DURGA: A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Oct 5, 2022 P1b/2, N=121, Active, not recruiting, In summary, we provide a paradigm for a vaccine approach that can be rapidly engineered and customized for any future pathogens that require induction of effective tissue-resident memory responses in epithelial tissues. Completed --> Active, not recruiting | Trial completion date: Aug 2022 --> Nov 2022
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[VIRTUAL] Heat Biologics () - May 31, 2021 - Abstract #BIO2021BIO_366; The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
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[VIRTUAL] Development of a gp96-Ig vaccine for COVID-19 () - May 19, 2021 - Abstract #IMMUNOLOGY2021IMMUNOLOGY_1482; We showed that our vaccine platform effectively stimulates a robust cellular immune response against protein S. Moreover, we confirmed that gp96-Ig, secreted from allogeneic cells expressing full-length protein S, generates powerful, protein S polyepitope-specific CD4+ and CD8+ T cell responses in both lung interstitium and airways. These findings were further strengthened by the observation that protein-S -specific CD8+ T cells were induced in human leukocyte antigen (HLA)-A2-02-01 transgenic mice thus providing encouraging translational data that the vaccine is likely to work in humans, in the context of SARS-CoV-2 antigen presentation.
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Trial completion date, Trial primary completion date, Combination therapy: A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors (clinicaltrials.gov) - Jan 22, 2021 P1, N=30, Recruiting, Trial completion date: Dec 2021 --> Aug 2022 | Trial primary completion date: Dec 2020 --> Aug 2021 Trial completion date: May 2021 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Jun 2021
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Secreted heat shock protein gp96-Ig vaccine induces malaria specific intrahepatic CD8 T cell responses (Board Number: P1266) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_843; Also, we found an increased frequency of intrahepatic CD8+ T cells secreting IL-2, which is relevant for maintenance of effective memory responses. Our findings are strongly supportive of a novel gp96-Ig-based malaria vaccine as a unique systemic and liver-homing, liver-stage antigen-specific CD8+ cytotoxic T lymphocyte (CTL) vaccine strategy.
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Trial termination, Combination therapy, Metastases: A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 5, 2020 P2, N=66, Terminated, Our findings are strongly supportive of a novel gp96-Ig-based malaria vaccine as a unique systemic and liver-homing, liver-stage antigen-specific CD8+ cytotoxic T lymphocyte (CTL) vaccine strategy. Completed --> Terminated; Sponsor Decision; strategic - based on changing treatment landscape
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Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 22, 2019 P2, N=66, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=123 --> 66 | Trial completion date: Sep 2018 --> Apr 2018 | Trial primary completion date: Sep 2017 --> Dec 2017
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Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker: DURGA: A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 13, 2018 P1b/2, N=120, Recruiting, Active, not recruiting --> Completed | N=123 --> 66 | Trial completion date: Sep 2018 --> Apr 2018 | Trial primary completion date: Sep 2017 --> Dec 2017 Trial completion date: Mar 2019 --> Dec 2021 | Trial primary completion date: Dec 2018 --> Dec 2019
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Enrollment change, Trial withdrawal, Metastases: Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 17, 2014 P1, N=0, Withdrawn, Recruiting --> Active, not recruiting N=36 --> 0 | Not yet recruiting --> Withdrawn
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