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[{"orgOrder":0,"company":"GSK","sponsor":"Xiamen Innovax Biotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"GSK allies with Innovax for COVID-19 vaccine R&D project","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Medicago","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medicago Announces Positive Phase 1 Results for Its Covid-19 Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Clover Biopharmaceuticals","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CHINA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Icahn School of Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mount Sinai Researchers Advance a Universal Influenza Virus Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Medicago","sponsor":"National Institutes of Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medicago and GSK Start Phase 3 Trial of Adjuvanted Covid-19 Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Medicago","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brazilian Health Regulator Anvisa Authorizes Trials for GSK-Medicago COVID Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Medicago","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada to Start Real-Time Review of Medicago COVID-19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Medicago","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted Covid-19 Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Medicago","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medicago and GSK Announce Positive Phase 3 Efficacy and Safety Results for Adjuvanted Plant-Based COVID-19 Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Medicago","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medicago Submits Phase 3 Data to Health Canada for Its Plant-Based COVID-19 Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi and GSK to Seek Regulatory Authorization for Covid19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Vaccine","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"SK Chemicals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Regulatory Approval of COVID-19 Vaccine SKYCovion","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for AS03
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Companies By Therapeutic Area
Details:
Data from Phase 3 VAT08 and VAT02 efficacy study showed that two doses of Sanofi-GSK booster vaccine SP0253 or GSK4353001A (SARS-CoV-2 recombinant protein vaccine) generated an efficacy of 100%, 75%, 57.9% against severe COVID-19 disease.
Lead Product(s):
SARS-CoV-2 Recombinant Protein Vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: SP0253
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 23, 2022
Details:
SKYCovion contains nanoparticles of recombinant Receptor Binding Domain (RBD) of SARS-CoV-2 Spike (S) protein from the parental D614G strain and an adjuvant system (AS03) and got approval by MHRA for treating COVID-19 infection.
Lead Product(s):
Recombinant Adjuvanted Covid-19 Vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: SKYCovion
Highest Development Status: Approved
Product Type: Vaccine
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 26, 2023
Details:
Apart from Canada regulatory filing has also been initiated for USFDA and MHRA for CoVLP (Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine), the first-ever plant-based vaccine, final portion of data submitted as part of New Drug Submission COVID rolling review.
Lead Product(s):
Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: CoVLP
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 16, 2021
Details:
Covid19 Vaccine candidate demonstrated efficacy against all variants seen in the study, including 75.3% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant.
Lead Product(s):
CoVLP Adjuvanted Vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 07, 2021
Details:
The Phase 3 portion is an event-driven, randomized, observer-blinded, crossover placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in up to 30,000 subjects.
Lead Product(s):
Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: CoVLP
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 18, 2021
Details:
Medicago’s plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK’s pandemic adjuvant.
Lead Product(s):
Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: CoVLP
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 23, 2021
Details:
Anvisa said the companies were authorized to conduct phase 3 trials in the country. The companies are planning to test the new vaccines in around 30,000 people, in the U.S., Canada, Europe and Latin America. Brazil may have around 3,500 volunteers for the trials.
Lead Product(s):
Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 08, 2021
Details:
Medicago's plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant.
Lead Product(s):
Recombinant Coronavirus Virus-Like Particle COVID-19 vaccine,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase II/ Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
National Institutes of Health
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 16, 2021
Details:
CH8/1N1 LAIV produced a strong, functional immune response with cross-reactive antibodies targeting the hemagglutinin stalk domain, which were detectable for at least 18 months following vaccination in 65 healthy, 18 to 39-year-old US participants.
Lead Product(s):
CH8/1N1 LAIV,AS03
Therapeutic Area: Infections and Infectious Diseases
Product Name: CH8/1N1 LAIV
Highest Development Status: Phase I
Product Type: Vaccine
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 07, 2020
Details:
Clover’s protein-based COVID-19 vaccine candidates adjuvanted with either GSK’s pandemic adjuvant system or Dynavax’s CpG 1018 plus alum induced strong neutralizing immune responses in 150 adult and elderly subjects from the Phase 1 clinical study.
Lead Product(s):
Adjuvanted COVID-19 S-Trimer vaccine,AS03 ,CpG-1018
Therapeutic Area: Infections and Infectious Diseases
Product Name: SCB-2019
Highest Development Status: Phase II/ Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
GSK
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 04, 2020