GNOS-PV01 / Geneos Therap - LARVOL DELTA

DNA, Peptide Vaccines Advance Against GBM. (PubMed, Cancer Discov) - "Phase I trial findings indicate that two different personalized vaccine strategies, DNA-based GNOS-PV01 and peptide-based NeoVax, may be promising strategies for patients with glioblastoma. Notably, the former is effective against MGMT-unmethylated glioblastoma, a subtype for which the prognosis is particularly poor."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Adjuvant personalized multivalent neoantigen DNA vaccination for MGMT unmethylated glioblastoma: a phase 1 trial. (PubMed, Nat Cancer) - P1 | "The vaccine induced activation and expansion of circulating peripheral T cells in all evaluated patients, except one who was being treated with dexamethasone. This study met the pre-specified endpoints and supports the use of GNOS-PV01 as a potentially impactful component of glioblastoma immunotherapy. ClinicalTrials.gov: NCT04015700 ."

Journal • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2025 ➔ Sep 2027

Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Personalized multivalent DNA vaccination safely induces broad neoantigen-specific T cell responses in newly diagnosed MGMT unmethylated glioblastoma in a clinically relevant time scale (SNO 2025) - P1 | "Patients with unmethylated O6-methylguanine methyltransferase (MGMT) promoters do not derive survival benefit from adjuvant temozolomide...Here, we report the results of a phase 1 clinical trial (NCT04015700) evaluating the safety and feasibility of GNOS-PV01, a personalized DNA vaccination platform that safely immunized against up to 40 patient-specific neoantigens in a clinically relevant timescale following surgical resection and radiation for MGMT-unmethylated glioblastoma patients...Exposure to dexamethasone greatly suppressed immune reactivity, while PD-1 blockade enhanced local immune responses. With respect to efficacy, one third of patients survived longer than 24 months with one long-term survivor living >40 months from time of diagnosis, exceeding survival of recently published trials. Thus, our study demonstrates the safety, feasibility, and preliminary clinical efficacy of a personalized multivalent neoantigen vaccination platform in a devastating..."

Clinical • IO biomarker • Tumor-specific neoantigens • Brain Cancer • Glioblastoma • Solid Tumor • CD4 • CD8 • MGMT

Personalized multivalent DNA vaccination safely induces broad neoantigen-specific T cell responses in newly diagnosed MGMT unmethylated glioblastoma in a clinically relevant time scale (SNO 2025) - P1 | "Patients with unmethylated O6-methylguanine methyltransferase (MGMT) promoters do not derive survival benefit from adjuvant temozolomide...Here, we report the results of a phase 1 clinical trial (NCT04015700) evaluating the safety and feasibility of GNOS-PV01, a personalized DNA vaccination platform that safely immunized against up to 40 patient-specific neoantigens in a clinically relevant timescale following surgical resection and radiation for MGMT-unmethylated glioblastoma patients...Exposure to dexamethasone greatly suppressed immune reactivity, while PD-1 blockade enhanced local immune responses. With respect to efficacy, one third of patients survived longer than 24 months with one long-term survivor living >40 months from time of diagnosis, exceeding survival of recently published trials. Thus, our study demonstrates the safety, feasibility, and preliminary clinical efficacy of a personalized multivalent neoantigen vaccination platform in a devastating..."

Clinical • IO biomarker • Tumor-specific neoantigens • Brain Cancer • Glioblastoma • Solid Tumor • CD4 • CD8 • MGMT

Personalized multivalent DNA vaccination safely induces broad neoantigen-specific T cell responses in newly diagnosed MGMT unmethylated glioblastoma in a clinically relevant time scale (WFNOS 2025) - P1 | "Patients with unmethylated O6-methylguanine methyltransferase (MGMT) promoters do not derive survival benefit from adjuvant temozolomide...Here, we report the results of a phase 1 clinical trial (NCT04015700) evaluating the safety and feasibility of GNOS-PV01, a personalized DNA vaccination platform that safely immunized against up to 40 patient-specific neoantigens in a clinically relevant timescale following surgical resection and radiation for MGMT-unmethylated glioblastoma patients...Exposure to dexamethasone greatly suppressed immune reactivity, while PD-1 blockade enhanced local immune responses. With respect to efficacy, one third of patients survived longer than 24 months with one long-term survivor living >40 months from time of diagnosis, exceeding survival of recently published trials. Thus, our study demonstrates the safety, feasibility, and preliminary clinical efficacy of a personalized multivalent neoantigen vaccination platform in a devastating..."

Clinical • IO biomarker • Tumor-specific neoantigens • Brain Cancer • Glioblastoma • Glioma • Solid Tumor • CD4 • CD8 • MGMT

Personalized multivalent DNA vaccination safely induces broad neoantigen-specific T cell responses in newly diagnosed MGMT unmethylated glioblastoma in a clinically relevant time scale (WFNOS 2025) - P1 | "Patients with unmethylated O6-methylguanine methyltransferase (MGMT) promoters do not derive survival benefit from adjuvant temozolomide...Here, we report the results of a phase 1 clinical trial (NCT04015700) evaluating the safety and feasibility of GNOS-PV01, a personalized DNA vaccination platform that safely immunized against up to 40 patient-specific neoantigens in a clinically relevant timescale following surgical resection and radiation for MGMT-unmethylated glioblastoma patients...Exposure to dexamethasone greatly suppressed immune reactivity, while PD-1 blockade enhanced local immune responses. With respect to efficacy, one third of patients survived longer than 24 months with one long-term survivor living >40 months from time of diagnosis, exceeding survival of recently published trials. Thus, our study demonstrates the safety, feasibility, and preliminary clinical efficacy of a personalized multivalent neoantigen vaccination platform in a devastating..."

Clinical • IO biomarker • Tumor-specific neoantigens • Brain Cancer • Glioblastoma • Glioma • Solid Tumor • CD4 • CD8 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Apr 2023 ➔ Dec 2023

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Apr 2023 | Trial primary completion date: Dec 2023 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Nov 2023 ➔ Nov 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Jul 2023 ➔ Nov 2023 | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Washington University School of Medicine; Trial completion date: Jul 2024 ➔ Jul 2023; Trial primary completion date: Oct 2023 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2 • MGMT

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Washington University School of Medicine; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD8 • IDH1 • IDH2

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Washington University School of Medicine; Trial completion date: Apr 2024 ➔ Aug 2024; Initiation date: Apr 2020 ➔ Aug 2020; Trial primary completion date: Jul 2023 ➔ Nov 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology