PepVax (Tet-CMV) / Fortress - LARVOL DELTA

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=61 | Completed | Sponsor: City of Hope Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • HLA-B • HLA-C • HLA-DRB1

Antiviral Agents for Preventing Cytomegalovirus Disease in Recipients of Hematopoietic Cell Transplantation. (PubMed, Viruses) - "The approval of the anti-CMV drug letermovir has made antiviral prophylaxis more popular...Maribavir (MBV) has been approved for the treatment of post-transplant CMV infection/disease in adolescents. Adoptive T-cell therapy and the PepVax CMV vaccine show promise in tackling refractory and resistant CMV...Cell-mediated immunity assays are valuable for personalized management plans, but more interventional studies are needed. MBV and adoptive T-cell therapy are promising treatments, and trials for CMV vaccines are ongoing."

Journal • Review • Cytomegalovirus Infection • Infectious Disease • Pediatrics • Transplantation

AutoPepVax, a Novel Machine-Learning-Based Program for Vaccine Design: Application to a Pan-Cancer Vaccine Targeting EGFR Missense Mutations. (PubMed, Pharmaceuticals (Basel)) - "AutoPepVax's comprehensive approach to in silico epitope selection addresses vaccine safety, efficacy, and broad applicability. Future studies aim to validate the AutoPepVax-designed vaccines with murine tumor models that harbor the studied mutations."

IO biomarker • Journal • Machine learning • Pan tumor • Brain Cancer • CNS Tumor • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: City of Hope Medical Center | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Burkitt Lymphoma • Chronic Eosinophilic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • CNS Lymphoma • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Diffuse Large B Cell Lymphoma • Essential Thrombocythemia • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypereosinophilic Syndrome • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Monoclonal Gammopathy • Multiple Myeloma • Mycosis Fungoides • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Plasmacytoma • Polycythemia Vera • Prolymphocytic Leukemia • Sezary Syndrome • Small Lymphocytic Lymphoma • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • Thrombocytosis • Transplantation • Waldenstrom Macroglobulinemia • HLA-DRB1

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=61 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • HLA-B • HLA-C • HLA-DRB1

A phase II randomized, placebo-controlled, multicenter trial to evaluate the efficacy of cytomegalovirus PepVax vaccine in preventing cytomegalovirus reactivation and disease after allogeneic hematopoietic stem cell transplant. (PubMed, Haematologica) - "Not available."

Journal • P2 data • Bone Marrow Transplantation • Cytomegalovirus Infection • Transplantation

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: City of Hope Medical Center | N=133 ➔ 76

Enrollment change • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • HLA-B • HLA-C • HLA-DRB1

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=133 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial primary completion date: Apr 2023 ➔ Dec 2023

Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD8 • HLA-B • HLA-C • HLA-DRB1

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=133 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD8 • HLA-B • HLA-C • HLA-DRB1

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Nov 2022 ➔ Nov 2023 | Trial primary completion date: Nov 2022 ➔ Nov 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Burkitt Lymphoma • Chronic Eosinophilic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • CNS Lymphoma • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Diffuse Large B Cell Lymphoma • Essential Thrombocythemia • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypereosinophilic Syndrome • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Monoclonal Gammopathy • Multiple Myeloma • Mycosis Fungoides • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Plasmacytoma • Polycythemia Vera • Prolymphocytic Leukemia • Sezary Syndrome • Small Lymphocytic Lymphoma • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • Thrombocytosis • Transplantation • Waldenstrom Macroglobulinemia • CD8 • HLA-DRB1 • PD-1

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=133 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD8 • HLA-B • HLA-C • HLA-DRB1

A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy of Cmvpepvax for Preventing CMV Reactivation/Disease after Matched Related/Unrelated Donor Hematopoietic Cell Transplant (ASH 2021) - P2 | "Preemptive antiviral therapy is associated with drug-induced toxicities, and prophylactic therapy with letermovir is associated with late reactivations and delayed antiviral immune reconstitution...Our group has developed a peptide vaccine, CMVPepvax, composed of an HLA-A*0201 restricted pp65 495-503 CD8 T cell epitope, covalently linked to a universal tetanus T helper epitope and co-administered with PF-03512676 adjuvant...Early CMV reactivation/disease detected before receipt of the second vaccine may have reduced the ability of PepVax to elicit a protective T cell response. Transfer of vaccine-induced immunity through donor CMV immunization combined with recipient booster immunization may overcome this issue and lead to faster immune reconstitution post-HCT."

Clinical • P2 data • Acute Graft versus Host Disease • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Tetanus • Transplantation • CD8 • PTPRC

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Nov 2021 ➔ Nov 2022 | Trial primary completion date: Nov 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Burkitt Lymphoma • Chronic Eosinophilic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • CNS Lymphoma • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypereosinophilic Syndrome • Indolent Lymphoma • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Monoclonal Gammopathy • Multiple Myeloma • Mycosis Fungoides • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Plasmacytoma • Polycythemia Vera • Prolymphocytic Leukemia • Sezary Syndrome • Small Lymphocytic Lymphoma • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • Thrombocytosis • Transplantation • Waldenstrom Macroglobulinemia • CD8 • HLA-DRB1 • PD-1

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2 | N=133 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD8 • HLA-B • HLA-C • HLA-DRB1

CMV Infection in Hematopoietic Stem Cell Transplantation: Prevention and Treatment Strategies. (PubMed, Curr Treat Options Infect Dis) - "The approval of the novel anti-CMV drug letermovir in 2017 has led to an increase in the use of antiviral prophylaxis as a preferred approach for prevention in many centers...Of the different CMV vaccine trials, PepVax has shown promising results in a phase 1 trial...Maribavir and adoptive T cell therapy are promising new therapies for treatment of CMV infections. CMV vaccine trials for prevention are also under way."

Journal • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Transplantation

"How should the US support global vaccination? Pepfar —> Pepvax @realDrBirx @CarlosdelRio7" (@drklausner)

Clinical

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2; N=133; Active, not recruiting; Sponsor: City of Hope Medical Center; Recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Dec 2021; Trial primary completion date: May 2020 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD8 • HLA-DRB1

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Mar 2020 ➔ Nov 2021; Trial primary completion date: Mar 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date

"@AmarexClinical @emergentbiosolu @GenArraytion @GSKUS @HealthSolnRsrch @immunomix @NEXTBio1 @NovavaxInc @Pepvax @QIAGEN @VigeneBio @USPharmacopeia @ZalgenLabs @US_FDA @NIH @NIAIDNews" (@think_moco)

Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Non-Viremic Hematopoietic Stem Transplant Recipients Vaccinated with CMVPepVax. (PubMed, Biol Blood Marrow Transplant) - P1; "Collectively, our analysis indicates that, in the absence of clinically relevant viremia, CMVPepVax reconstituted significant levels of differentiated effector memory pp65-specific CD8 T cells early post-HCT. The body of data from this current study indicates that the rapid reconstitution of CMV-specific T cells, with marked levels of effector phenotypes may have been key to the favorable outcomes of the CMVPepVax clinical trial."

Clinical • Journal

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Sep 2019 ➔ Mar 2020; Trial primary completion date: Sep 2019 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2; N=133; Recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Jun 2019 ➔ May 2020; Trial primary completion date: Jun 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov) - P2; N=133; Recruiting; Sponsor: City of Hope Medical Center; Active, not recruiting ➔ Recruiting; N=96 ➔ 133

Clinical • Enrollment change • Enrollment open

Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Non-Viremic Hematopoietic Stem Transplant Recipients Vaccinated with Cmvpepvax (TCT-ASBMT-CIBMTR 2019) - "Collectively, our analysis indicates that, in the absence of clinically relevant viremia, CMVPepVax reconstituted significant levels of differentiated effector memory CD8 T cells specific to the vaccine epitope of pp65495-503 early post-HCT, which may have been key to the favorable outcomes of the CMVPepVax clinical trial."

Clinical • IO Biomarker

"#TCTM19 Forman: CMV vaccine developed at City of Hope, CMV Pepvax, looked promising, but only useful for HLA-A*02" (@hemedoc)