Cytomegalovirus vaccine

Phase 3 Clinical Trial Subgroup Analysis Across Solid Organ Transplant (SOT) Types Supports Efficacy of Maribavir Over Conventional Therapies in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance)

Retrieved on: 
Monday, June 7, 2021
Science, Biotechnology, Research, Pharmaceutical, Surgery, Health, Infectious diseases, Clinical trials, Organic compounds, Chemistry, Chemical compounds, Benzimidazoles, Chloroarenes, Maribavir, Nucleosides, Human betaherpesvirus 5, Cytomegalovirus vaccine, CMV, Maribavir, Takeda’s SOLSTICE Trial, Takeda Pharmaceutical Company Limited, CMV, MARIBAVIR, TAKEDA’S SOLSTICE TRIAL, TAKEDA PHARMACEUTICAL COMPANY LIMITED

Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.

Key Points: 
  • Most recently, the FDA has granted priority review of maribavir for the treatment of post-transplant recipients with CMV infection in those R/R to prior anti-CMV treatment.
  • Avery R. Randomized Phase 3 Open-Label Study of Maribavir vs Investigator-Assigned Therapy for Refractory/Resistant Cytomegalovirus Infection in Transplant Recipients: Subgroup Analyses of Efficacy by Organ.
  • Duarte R. Maribavir Versus Investigator-Assigned Therapy for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus Infection: Efficacy Data From a Randomized Phase 3 Open-Label Study.
  • Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients.

VBI Vaccines Announces U.S. FDA Acceptance of BLA Filing for VBI’s 3-Antigen Prophylactic Hepatitis B Vaccine

Retrieved on: 
Tuesday, February 2, 2021
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Medical specialties, Clinical medicine, Vaccination, Vaccines, Hepatitis B, Vaccine, Virology, Hepatitis B vaccine, Cytomegalovirus vaccine, Virus-like particle, Hepatitis B, VBI’s 3-Antigen Hepatitis B Vaccine, VBI Vaccines Inc.

The studies were designed to assess the efficacy and safety of VBIs 3-antigen HBV vaccine compared with Engerix-B, as well as the lot-to-lot manufacturing consistency of VBIs vaccine.

Key Points: 
  • The studies were designed to assess the efficacy and safety of VBIs 3-antigen HBV vaccine compared with Engerix-B, as well as the lot-to-lot manufacturing consistency of VBIs vaccine.
  • VBIs vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel.
  • To learn more about VBIs 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/
    VBI Vaccines Inc. ( Nasdaq: VBIV ) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program.

VBI Vaccines Announces Progress of Coronavirus Vaccine Program

Retrieved on: 
Thursday, January 21, 2021
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Medicine, Health sciences, Medical research, Medical specialties, COVID-19 vaccine, Vaccine, Coronavirus, Severe acute respiratory syndrome, Cytomegalovirus vaccine

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today provided an update on the progress of its coronavirus vaccine program, consisting of two vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today provided an update on the progress of its coronavirus vaccine program, consisting of two vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.
  • VBI Vaccines Inc. ( Nasdaq: VBIV ) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program.
  • VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

VBI Vaccines Announces Publication of Results from a Phase 4 Study of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine in Vaccine

Retrieved on: 
Friday, January 15, 2021
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Medical specialties, Medicine, Vaccines, Medical research, Virology, Vaccination, Vaccine, Hepatitis B vaccine, COVID-19 vaccine, Hepatitis B, Cytomegalovirus vaccine, Vaxart, Hepatitis B, VBI’s 3-Antigen Hepatitis B Vaccine, VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBIs prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBIs prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier.
  • In this Phase 4 study, our 3-antigen HBV vaccine once again demonstrated robust immunogenicity with no additional safety signals observed, said Dr. Francisco Diaz-Mitoma, VBIs Chief Medical Officer.
  • Prior to market release in Israel, batches of VBIs vaccine are tested against a reference vaccine batch that has been assessed in a clinical trial.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program.

HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

Retrieved on: 
Monday, November 30, 2020
Medical specialties, Medicine, Vaccines, Clinical medicine, Antibodies, Neutralizing antibody, Vaccine, Medical research, Cytomegalovirus vaccine, Human betaherpesvirus 5

The interim immunogenicity analysis also included CMV-neutralizing antibody data assessed from 33 individuals, a subset of the 41 included in the efficacy analysis.

Key Points: 
  • The interim immunogenicity analysis also included CMV-neutralizing antibody data assessed from 33 individuals, a subset of the 41 included in the efficacy analysis.
  • In line with previous interim data, 100 percent of the participants who received three doses of HB-101 mounted CMV-neutralizing antibodies.
  • Specifically, 17 percent of participants across the combined HB-101 and placebo groups showed side effects related to vaccine administration.
  • HOOKIPAs non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation.

VBI Vaccines Announces Positive Interim Phase 2a Data from VBI-1901 in Recurrent GBM

Retrieved on: 
Thursday, November 19, 2020
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Medical specialties, Clinical medicine, Medicine, Oncology, Brain tumor, Cancer, Glioblastoma, Vaccines, Vaccine, Cancer immunotherapy, Cytomegalovirus vaccine, the Phase 1/2a Study Design, VBI-1901 and GBM, VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, the companys cancer vaccine immunotherapeutic candidate designed to target cytomegalovirus (CMV) as a foreign viral antigen in recurrent glioblastoma (GBM).

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, the companys cancer vaccine immunotherapeutic candidate designed to target cytomegalovirus (CMV) as a foreign viral antigen in recurrent glioblastoma (GBM).
  • Few treatment options are available to recurrent glioblastoma patients, and the tumor response data seen to-date in this ongoing study are encouraging.
  • A copy of the e-poster is available on the Events/Presentations page in the Investors section of the VBI Vaccines website.
  • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 g, 2.0 g, and 10.0 g.
    Enrollment completed in December 2018.

VBI Vaccines Announces e-Poster Presentation at the Society for Neuro-Oncology (SNO) 2020 Virtual Meeting

Retrieved on: 
Monday, November 9, 2020
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Medicine, Medical specialties, Medical research, Vaccines, Health sciences, COVID-19 vaccine, Vaccine, Cancer immunotherapy, Cytomegalovirus vaccine, Herpes simplex research, the Phase 1/2a Study Design, VBI-1901 and GBM, VBI Vaccines Inc.

Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

Key Points: 
  • Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.
  • VBI Vaccines Inc. ( Nasdaq: VBIV ) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic pan-coronavirus vaccine candidate.
  • VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

VBI Vaccines Awarded Up to CAD$56 Million Contribution from Canadian Government to Accelerate Coronavirus Vaccine Development

Retrieved on: 
Wednesday, August 5, 2020
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Health, Medicine, Medical specialties, Vaccines, Medical research, COVID-19 vaccine, Coronavirus, Vaccine, Virus, Cytomegalovirus vaccine, Herpes simplex research, Coronaviruses, VBI Vaccines Inc.

Coronaviruses are enveloped viruses by nature, which make them prime targets for VBIs flexible enveloped virus-like particle (eVLP) platform technology.

Key Points: 
  • Coronaviruses are enveloped viruses by nature, which make them prime targets for VBIs flexible enveloped virus-like particle (eVLP) platform technology.
  • This funding will help accelerate our vaccine candidates into and through clinical development, the first clinical studies for which are expected to initiate by the end of 2020.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic pan-coronavirus vaccine candidate.
  • VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

VBI Vaccines Announces Collaboration with the National Research Council of Canada to Develop Pan-Coronavirus Vaccine Candidate Targeting COVID-19, SARS, and MERS

Retrieved on: 
Tuesday, March 31, 2020
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Viruses, Vaccines, Medicine, Health, Cytomegalovirus vaccine, Coronaviridae, Coronavirus, Severe acute respiratory syndrome, Vaccine, Coronaviruses, VBI Vaccines Inc.

VBI Vaccines Inc. (NASDAQ: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced a collaboration with the National Research Council of Canada (NRC), Canadas largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Key Points: 
  • VBI Vaccines Inc. (NASDAQ: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced a collaboration with the National Research Council of Canada (NRC), Canadas largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).
  • Under the terms of the agreement, the NRC and VBI will collaborate to evaluate and select the optimal vaccine candidate.
  • VBIs lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM) and a prophylactic CMV vaccine candidate.
  • VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

VBI Vaccines Provides Update on Part A of Ongoing Phase 1/2a Study Demonstrating Overall Survival Benefit for VBI-1901 Vaccine Responders in Recurrent GBM Patients

Retrieved on: 
Tuesday, March 3, 2020
Research, Infectious diseases, FDA, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Vaccines, Medicine, Health, Medical specialties, Cytomegalovirus vaccine, Glioblastoma, Vaccine, Herpes simplex research

For patients who had an immunologic response to the vaccine, considered to be vaccine responders, the 12-month overall survival (OS) rate was 83% (n=5/6), compared to 33% for vaccine non-responders (n=3/9).

Key Points: 
  • For patients who had an immunologic response to the vaccine, considered to be vaccine responders, the 12-month overall survival (OS) rate was 83% (n=5/6), compared to 33% for vaccine non-responders (n=3/9).
  • Similarly, among patients evaluable for response and survival in Part A, vaccine responders saw a 6.25-month improvement in median OS (14.0 months) compared to vaccine non-responders (7.75 months).
  • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 g, 2.0 g, and 10.0 g.
    Enrollment completed in December 2018.
  • VBIs lead eVLP program candidates include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a cytomegalovirus (CMV)-associated tumor, and a prophylactic CMV vaccine candidate.