Immunogenicity

Clover Biopharmaceuticals Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate

Retrieved on: 
Friday, June 19, 2020
Health, Infectious diseases, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Vaccination, Vaccines, Medicine, Virology, Health, Vaccine efficacy, Vaccine, Immunogenicity, Ebola, Clover Biopharmaceuticals, Trimer-Tag© Technology, COVID-19 S-Trimer Vaccine

Clover Biopharmaceuticals today announced that the first participants have been dosed in the Phase 1 first-in-human study evaluating the companys COVID-19 S-Trimer subunit vaccine candidate (SCB-2019), which is based on Clovers proprietary Trimer-Tag vaccine technology platform.

Key Points: 
  • Clover Biopharmaceuticals today announced that the first participants have been dosed in the Phase 1 first-in-human study evaluating the companys COVID-19 S-Trimer subunit vaccine candidate (SCB-2019), which is based on Clovers proprietary Trimer-Tag vaccine technology platform.
  • In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020.
  • The Phase I clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels.
  • The trial and Clovers COVID-19 vaccine program is being supported by the funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI).

Dynavax Completes Enrollment of Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis

Retrieved on: 
Tuesday, June 9, 2020
Medicine, Clinical medicine, Medical specialties, RTT, Hepatitis B vaccine, Hepatitis, Immunogenicity, HBV, Hemodialysis, Clinical trial

Completing patient enrollment for this study is a significant milestone for our company, commented Robert Janssen , MD, Chief Medical Officer at Dynavax.

Key Points: 
  • Completing patient enrollment for this study is a significant milestone for our company, commented Robert Janssen , MD, Chief Medical Officer at Dynavax.
  • The study, HBV-24, is an open-label, single-arm trial being conducted in the United States to evaluate a new 4-dose regimen of HEPLISAV-Bin adults with ESRD who are undergoing hemodialysis and have not previously received a hepatitis B vaccine.
  • The study is designed to evaluate HEPLISAV-Bs immunogenicity at study week 20 and safety over the 68-week study duration.
  • This press release contains forward-looking statements, including statements regarding the timing of completion of our clinical study assessing use of HEPLISAV-B in adults undergoing hemodialysis.

Alpine Immune Sciences Provides Clinical Update of its Phase 1 Trial of ALPN-101 in Healthy Volunteers at the European League Against Rheumatism (EULAR) E-Congress 2020

Retrieved on: 
Monday, June 8, 2020
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Infectious diseases, Clinical trials, Medical specialties, Medicine, Immunology, Transplantation medicine, Immunogenicity, Graft-versus-host disease, Cytokine, ALPN-101, Alpine Immune Sciences, Inc.

At all dose levels, ALPN-101 was well tolerated with no severe adverse events, clinically-significant immunogenicity events, or evidence of cytokine release.

Key Points: 
  • At all dose levels, ALPN-101 was well tolerated with no severe adverse events, clinically-significant immunogenicity events, or evidence of cytokine release.
  • They demonstrate the safety, tolerability, and pharmacological activity of multi-dose regimens, enabling the design of Phase 2 studies.
  • Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients lives via unique protein engineering technologies.
  • ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated.

Genocea Presents Updated Long-term Safety, Immunogenicity and Durability Data from GEN-009 Neoantigen Vaccine Phase 1/2a Trial Part A at Virtual ASCO 2020

Retrieved on: 
Friday, May 29, 2020
Medical specialties, Branches of biology, Medicine, Immunology, Immunogenicity, Antigen, Vaccine, ImmunoGen, Individualized cancer immunotherapy

CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the companys lead neoantigen vaccine candidate.

Key Points: 
  • CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the companys lead neoantigen vaccine candidate.
  • Title: GEN-009, a neoantigen vaccine containing ATLAS-selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.
  • Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year.
  • No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant.

Chimeron Bio and George Mason University’s National Center for Biodefense and Infectious Diseases Partner to Develop a Coronavirus (COVID-19) Vaccine using ChaESARTM Technology

Retrieved on: 
Thursday, May 28, 2020
Other Health, Research, Pharmaceutical, Infectious diseases, University, Genetics, Education, Clinical trials, Science, Biotechnology, Other Science, Health, Medical specialties, Medicine, Animal virology, Microbiology, Vaccination, Vaccine, Virology, Biodefense, Immunogenicity, Coronavirus, Virus, Infection, Chimeron Bio, George Mason University

Chimeron Bio , an RNA therapeutics company, and George Mason Universitys National Center for Biodefense and Infectious Diseases (NCBID), a leading institute conducting pioneering research on infectious diseases including diagnostic, therapeutics and vaccine development, today announced their partnership to develop a Coronavirus (COVID-19) vaccine.

Key Points: 
  • Chimeron Bio , an RNA therapeutics company, and George Mason Universitys National Center for Biodefense and Infectious Diseases (NCBID), a leading institute conducting pioneering research on infectious diseases including diagnostic, therapeutics and vaccine development, today announced their partnership to develop a Coronavirus (COVID-19) vaccine.
  • ChaESARTM, a self-amplifying RNA delivery technology, can deliver highly immunogenic viral genes to elicit rapid and sustained immune response.
  • The company is using its proprietary ChaESAR platform to develop a pipeline in oncology, rare genetic disorders, and infectious diseases.
  • The National Center for Biodefense and Infectious Diseases (NCBID) focuses on host-pathogen interactions using proteomics and nanotechnology as they are applied to diagnostic, therapeutic, and vaccine development.

Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine

Retrieved on: 
Monday, May 25, 2020
Health, Medicine, Medical specialties, Vaccines, Virology, Clinical research, Design of experiments, Novavax, Vaccine, Severe acute respiratory syndrome-related coronavirus, Clinical trial, Immunogenicity

We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.

Key Points: 
  • We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.
  • A Phase 1 clinical trial of NVXCoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020.
  • Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020.
  • NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

Genocea to Present Long-term Follow-up Data from GEN-009 Neoantigen Vaccine at Virtual ASCO 2020

Retrieved on: 
Wednesday, May 13, 2020
Branches of biology, Medical specialties, Medicine, Vaccines, Vaccination, Cancer vaccines, Immunology, Antigen, Immune system, Vaccine, Immunogenicity, Individualized cancer immunotherapy

Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year.

Key Points: 
  • Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year.
  • No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant.
  • Title: GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.
  • Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time.

Bioanalytical Testing Services Market Worth $3.7 Billion by 2025 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Wednesday, May 13, 2020
Medicine, Branches of biology, Clinical medicine, Immunology, Laboratory techniques, Antibody, Glycoproteins, Assay, Immunogenicity, Biomarker

CHICAGO, May 13, 2020 /PRNewswire/ -- According to the new market research report "Bioanalytical Testing Services Market by Type (Cell-based Assays; Virology Testing; Method Development, Optimization, and Validation; Serology, Immunogenicity, and Neutralizing Antibodies; Biomarker Testing; Pharmacokinetic Testing), Application, End User - Global Forecasts to 2025", published by MarketsandMarkets, the global Bioanalytical Testing Services Market is valued at an estimated USD 2.1 billion in 2020 and is projected to reach USD 3.7 billion by 2025, at a CAGR of 11.8% during the forecast period.

Key Points: 
  • CHICAGO, May 13, 2020 /PRNewswire/ -- According to the new market research report "Bioanalytical Testing Services Market by Type (Cell-based Assays; Virology Testing; Method Development, Optimization, and Validation; Serology, Immunogenicity, and Neutralizing Antibodies; Biomarker Testing; Pharmacokinetic Testing), Application, End User - Global Forecasts to 2025", published by MarketsandMarkets, the global Bioanalytical Testing Services Market is valued at an estimated USD 2.1 billion in 2020 and is projected to reach USD 3.7 billion by 2025, at a CAGR of 11.8% during the forecast period.
  • Based on the type of service, the bioanalytical testing services market is segmented into cell-based assays; virology testing; method development optimization and validation; serology, immunogenicity, and neutralizing antibodies; biomarker testing; pharmacokinetic testing; and other services (biologics characterization, extractable & leachable testing, and stability testing).
  • The cell-based assays segment accounted for the largest share of the bioanalytical testing services market in 2019.
  • The global bioanalytical testing services market is segmented into five major regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa.

Bioanalytical Testing Services Market Worth $3.7 Billion by 2025 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Wednesday, May 13, 2020
Medicine, Branches of biology, Clinical medicine, Immunology, Laboratory techniques, Antibody, Glycoproteins, Assay, Immunogenicity, Biomarker

CHICAGO, May 13, 2020 /PRNewswire/ -- According to the new market research report "Bioanalytical Testing Services Market by Type (Cell-based Assays; Virology Testing; Method Development, Optimization, and Validation; Serology, Immunogenicity, and Neutralizing Antibodies; Biomarker Testing; Pharmacokinetic Testing), Application, End User - Global Forecasts to 2025", published by MarketsandMarkets, the global Bioanalytical Testing Services Market is valued at an estimated USD 2.1 billion in 2020 and is projected to reach USD 3.7 billion by 2025, at a CAGR of 11.8% during the forecast period.

Key Points: 
  • CHICAGO, May 13, 2020 /PRNewswire/ -- According to the new market research report "Bioanalytical Testing Services Market by Type (Cell-based Assays; Virology Testing; Method Development, Optimization, and Validation; Serology, Immunogenicity, and Neutralizing Antibodies; Biomarker Testing; Pharmacokinetic Testing), Application, End User - Global Forecasts to 2025", published by MarketsandMarkets, the global Bioanalytical Testing Services Market is valued at an estimated USD 2.1 billion in 2020 and is projected to reach USD 3.7 billion by 2025, at a CAGR of 11.8% during the forecast period.
  • Based on the type of service, the bioanalytical testing services market is segmented into cell-based assays; virology testing; method development optimization and validation; serology, immunogenicity, and neutralizing antibodies; biomarker testing; pharmacokinetic testing; and other services (biologics characterization, extractable & leachable testing, and stability testing).
  • The cell-based assays segment accounted for the largest share of the bioanalytical testing services market in 2019.
  • The global bioanalytical testing services market is segmented into five major regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa.

Beroni Group R&D Team Identifies 24 Types of Nanobodies for Rapid Detection and Treatment of Coronavirus (COVID-19)

Retrieved on: 
Friday, May 8, 2020
Medical specialties, Medicine, Single-domain antibody, Health, Severe acute respiratory syndrome-related coronavirus, Immunogenicity, Severe acute respiratory syndrome, SARS

Currently the team is using a wide range of techniques, including structural biology, computational biology and protein engineering, to optimize their properties.

Key Points: 
  • Currently the team is using a wide range of techniques, including structural biology, computational biology and protein engineering, to optimize their properties.
  • By further humanizing the nanobodies, the team has reduced their immunogenicity and enhanced the therapeutic efficacy.
  • The development of SARS-CoV-2 binding nanobodies will greatly improve the detection sensitivity and rate of SARS-CoV-2 and facilitate the treatment of COVID-19.
  • With the discovery of the 24 nanobodies, the research team is now prepared to conduct animal experiments and clinical trials which are expected to yield results within the next 12-18 months.