Gritstone in line for $433M in BARDA funds to push mRNA COVID-19 shot into large-scale trial

Gritstone bio is the latest drug developer to be tapped for the Biomedical Advanced Research and Development Authority’s (BARDA's) Project NextGen, with the biotech in line for more than $400 million to conduct a 10,000-person phase 2 study of its COVID-19 vaccine.

BARDA has contracted the company to conduct a U.S.-based randomized phase 2b trial assessing Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate against an approved vaccine. Preparations for the study, which will be fully funded by the government, are already underway, and the trial is due to kick off in the first quarter of 2024, the biotech said in the Sept. 27 release.

Gritstone’s candidate, which the company has dubbed the CORAL program, is designed to drive both B-cell and T-cell immunity against the virus that causes COVID-19 by using a combination of samRNA and immunogens containing both spike and additional viral targets.

“First-generation COVID-19 vaccines provided great utility during the height of the pandemic but are limited in breadth and durability of clinical protection,” CEO Andrew Allen, M.D., Ph.D., said. “CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 variants.”

The contract, worth up to $433 million, is part of the U.S. Department of Health and Human Services’ Project NextGen, which is focused on accelerating the development of new vaccines and therapeutics that can provide broader and stronger protection against COVID-19.

Recent months have seen a flurry of NextGen contracts go out, including $326 million pledged to Regeneron to push ahead with its next-generation monoclonal antibody against COVID-19.

Gritstone is best known for its work in cancer vaccines, with its lead program, dubbed GRANITE, in phase 2/3 trials for metastatic, microsatellite-stable colorectal cancer.

Evercore analyst Jonathan Miller said the BARDA announcement “does give some validation for Gritstone’s approach, and is certainly a nice signal of continued government support for COVID research.”

However, the GRANITE trial, which is expected to read out in the first quarter of 2024, is “by far the most important event” for the company from investors’ point of view, Miller added in a Sept 27 note.