FDA clears ImmunityBio to trial novel COVID-19 vaccine candidate

ImmunityBio has received FDA authorisation to begin a Phase I clinical trial of hAd5-COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

These dual constructs (bivalent sequences) of SARS-CoV-2 offer the potential for the hAd5 vaccine to provide recipients with durable, long-term cell-mediated immunity with potent antibody stimulation against both the S and N proteins.

The company anticipates launching a Phase I trial at Newport Beach, Calif. based Hoag Hospital this month with adult subjects up to age 55.

“While there are a number of vaccine candidates in development, we believe most are limited by their sole focus on antibody responses to the monovalent spike protein, which may be insufficient to activate the full potential of the immune system to fight the coronavirus,” said Dr. Patrick Soon-Shiong, Chairman and CEO of ImmunityBio.

“By targeting the nucleocapsid protein on the interior of the virus particle as well as the spike protein on the virus’s surface, we believe this vaccine can stimulate both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2.”

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...

BMS completes $13bn MyoKardia acquisition

Bristol Myers Squibb (BMS) has completed its $13.1 billion acquisition of MyoKardia. “We are excited to welcome MyoKardia colleagues to Bristol Myers Squibb,” said BMS...

Samsung Biologics breaks ground on ‘world’s largest’ biopharma manufacturing facility

Samsung Biologics has officially begun construction of its Plant 4 in Incheon, South Korea. Dubbed the “Super Plant”, the new, multi-story 238,000-square-meter construction will be...

Related news

Regeneron’s antibody cocktail granted Emergency Use Authorisation

The FDA has granted Emergency Use Authorisation (EUA) to Regeneron’s antibody cocktail for COVID-19. The cocktail combines casirivimab and imdevimab administered together is the first...

FairJourney Biologics enters antibody discovery agreement with Pandion Therapeutics

FairJourney Biologics S.A (FJB) and IONTAS Limited (IONTAS), leaders in the discovery and optimization of VHH and fully human antibodies, have signed an agreement...

Beckman Coulter launch SARS-CoV-2 IgM antibody test in countries accepting CE Mark

Beckman Coulter, a clinical diagnostics leader, has announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The...

95% efficiency for Pfizer & BioNTech’s mRNA-based COVID vaccine candidate

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine candidate – BNT162b2 – has achieved an efficiency rate of 95% after hitting all primary endpoints in a...