Biotech firm Gritstone bio has secured a contract worth up to $433 million from the Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study of its self-amplifying mRNA (samRNA) COVID-19 vaccine candidate. This study, part of the ‘Project NextGen’ initiative by the U.S. Department of Health and Human Services (HHS), aims to enhance the range and durability of COVID-19 protection.
The Co-founder, President, and Chief Executive Officer of Gritstone Bio, Dr. Andrew Allen, expressed his appreciation for the government’s trust and confidence in their groundbreaking vaccine approach. He emphasized the limitations of first-generation COVID-19 vaccines, stating, “First-generation COVID-19 vaccines provided great utility during the height of the pandemic but are limited in breadth and durability of clinical protection.”
Dr. Allen continued, “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. Across multiple Phase 1 studies, our samRNA vaccine, which incorporates both Spike and other viral targets (Spike plus), has demonstrated induction of potent immune responses with potential to drive broad and durable clinical protection.”
The contract entails a comprehensive Phase 2b double-blinded study with 10,000 participants, which aims to evaluate the efficacy, safety, and immunogenicity of Gritstone’s advanced COVID-19 vaccine candidate. This innovative vaccine leverages self-amplifying mRNA (samRNA) technology and will be compared against an already approved COVID-19 vaccine in a randomized setting.
Significantly, BARDA will fully fund the entire study. Gritstone Bio will collaborate closely with the COVID-19 Prevention Network (CoVPN), a well-established network of clinical trial sites based at the Fred Hutchinson Cancer Center, renowned for its experience in conducting large-scale COVID-19 vaccine trials.
Dr. Allen expressed his enthusiasm about the partnership with BARDA and anticipates the commencement of the Phase 2b study, CORAL-BARDA, in the first quarter of 2024.