Gritstone Bio has been selected as the latest participant in the Biomedical Advanced Research and Development Authority’s (BARDA) Project NextGen, securing a substantial investment exceeding $400 million. The funding will support the execution of a phase 2 clinical trial involving 10,000 participants for Gritstone’s COVID-19 vaccine.
Under this collaboration, BARDA has enlisted Gritstone to conduct a randomized phase 2b trial in the United States. This study will evaluate Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate against an approved COVID-19 vaccine. The preparations for this comprehensive trial, fully funded by the government, are already underway, with the anticipated commencement scheduled for the first quarter of 2024.
Gritstone’s COVID-19 vaccine candidate, designated as the CORAL program, is engineered to stimulate both B-cell and T-cell immunity responses against the virus responsible for COVID-19. It combines samRNA with immunogens encompassing spike proteins and additional viral targets.
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“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 variants.”
– CEO Andrew Allen, M.D., Ph.D
This BARDA contract, valued at up to $433 million, is an integral component of the US Department of Health and Human Services’ Project NextGen. This initiative is dedicated to accelerating the development of innovative vaccines and therapeutics that offer broader and more robust protection against COVID-19.
Recent developments within Project NextGen include a commitment of $326 million to Regeneron to advance its next-generation monoclonal antibody for combatting COVID-19.
While Gritstone is renowned for its contributions in the field of cancer vaccines, particularly its lead program GRANITE, currently in phase 2/3 trials for metastatic, microsatellite-stable colorectal cancer, this partnership with BARDA underscores the company’s expanding involvement in COVID-19 research. Analyst Jonathan Miller of Evercore noted that this announcement validates Gritstone’s approach and underscores ongoing government support for COVID-related research.
However, Miller highlighted that, from an investor’s perspective, the GRANITE trial, set to deliver results in the first quarter of 2024, remains the most significant event for the company.
