Vir, GSK begin trial for COVID-19 monoclonal antibody

By The Science Advisory Board staff writers

December 18, 2020 -- Vir Biotechnology and GlaxoSmithKline (GSK) have dosed the first patient in a new subtrial of the U.S. National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program phase III clinical trial.

The trial is designed to evaluate the safety and efficacy of VIR-7831 (also known as GSK4182136) for the treatment of hospitalized adults with COVID-19. VIR-7831 is an anti-SARS-CoV-2 investigational monoclonal antibody that was selected based on its potential to neutralize the coronavirus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs, the companies said.

ACTIV-3 will compare 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms. Participants will receive VIR-7831 or placebo as well as standard care for COVID-19, including the antiviral remdesivir.

If the VIR-7831 treatment arm appears to have a positive benefit/risk profile, the trial will enroll an additional 700 participants, including those who are more severely ill. Participants will be followed for 90 days after enrollment to analyze their response to treatment, with the primary efficacy end point being the participants' sustained recovery for 14 days after release from the hospital.

ACTIV-3 is one of several ongoing trials in the NIH's ACTIV program. It has been designed as a "master protocol" that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, within the same clinical trial structure across multiple sites.

GSK licenses cancer immunotherapy from Surface Oncology
GlaxoSmithKline (GSK) has obtained an exclusive license worldwide and commercial rights to Surface Oncology's preclinical program, SRF813, an antitumor...
Sanofi, GSK COVID-19 vaccine program delayed by responses in elderly
Sanofi and GlaxoSmithKline (GSK) are delaying their adjuvanted recombinant protein-based COVID-19 vaccine program to improve the vaccine's immune response...
Medicago, GSK begin phase II/III trial of adjuvanted COVID-19 vaccine
Medicago and GlaxoSmithKline (GSK) have begun a phase II/III clinical trial of their plant-derived COVID-19 vaccine candidate.
Harbour BioMed, Vir to develop new therapies
Harbour Biomed and Vir Biotechnology have partnered to research and develop novel immuno-oncology and infectious disease therapies.
Samsung Biologics, Vir partner on SARS-CoV-2 program
Samsung Biologics announced it will manufacture Vir Biotechnology's SARS-CoV-2 monoclonal antibody program for a potential COVID-19 treatment.
Generation Bio, Vir partner for mAbs against COVID-9
Generation Bio and Vir Biotechnology have agreed to collaborate on research into the use of monoclonal antibodies against the SARS-CoV-2 virus that causes...

Copyright © 2020 scienceboard.net


Conferences
Building Biology in 3D Hybrid Symposium
October 26-27
La Jolla, California United States
Northeast Regional Laboratory Staff and Core Directors (NERLSCD) 2021
November 3-5
Portsmouth, New Hampshire United States
CPhI Worldwide 2021
November 9-11
Milan, Lombardia Italy
Society for Immunotherapy of Cancer (SITC) Annual Meeting
November 10-14
Washington, DC, District of Columbia United States
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter