$433 Million Funds self-amplifying mRNA COVID-19 Vaccine Candidate
Gritstone bio, Inc. today announced that it was awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone's self-amplifying mRNA (samRNA) CORAL vaccine candidate containing Spike plus other viral targets to protect against COVID-19.
Gritstone's approach seeks to generate a therapeutic immune response by leveraging insights into the immune system's ability to recognize and destroy diseased cells by targeting select antigens.
The agreement, valued at up to $433 million, was awarded as part of 'Project NextGen,' an initiative by the U.S. Department of Health and Human Services (HHS).
Under the HHS contract, Gritstone will conduct a 10,000-participant, randomized Phase 2b double-blinded study in the United States in collaboration with the COVID-19 Prevention Network.
Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio, commented in a press release on September 27, 2023, "First-generation COVID-19 vaccines provided great utility during the height of the pandemic but are limited in breadth and durability of clinical protection."
"CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 (betacoronavirus) variants."
"We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024."
An introduction video is posted at this Gritstone About Us link.
This project has been funded with Federal funds from the Department of HHS, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00062.
In August 2023, HHS awarded more than $1.4 billion for Project NextGen through the Administration for Strategic Preparedness and Response.