Gritstone Bio has been granted a contract worth $433 million by the U.S. government to facilitate a mid-stage investigation of Gritstone’s self-amplifying mRNA COVID-19 vaccine candidate. It is a component of the larger “Project NextGen” effort led by the U.S. Department of Health and Human Services, which seeks to propel various groundbreaking vaccines and treatments forward with the goal of offering extensive and enduring safeguarding against COVID-19.
Following the announcement of this contract, Gritstone Bio witnessed a remarkable 36.1% increase in its share price, reaching $1.61. The upcoming study holds immense significance, as it will be responsible for evaluating the effectiveness, safety, and immunogenicity of Gritstone’s COVID-19 vaccine candidate, comparing it with a vaccine that has already received approval. The biotech company has set forth its plans to kickstart this mid-stage study in the first quarter of the forthcoming year.
This contract is the result of Gritstone’s collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a federal agency in the United States dedicated to funding cutting-edge disease-fighting technology. Gritstone Bio has been chosen as a pivotal participant in BARDA’s Project NextGen initiative, securing over $400 million for conducting a phase 2 study involving a staggering 10,000 participants for its COVID-19 vaccine.
The impending randomized phase 2b trial will occur within the United States and will involve a comparative assessment of Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate against an already approved vaccine.
Gritstone’s vaccine candidate, recognized as the CORAL program, has been meticulously engineered to stimulate both B-cell and T-cell immunity against the SARS-CoV-2 virus. This is achieved through a combination of samRNA and immunogens, which encompass spike proteins as well as additional viral targets. CEO Andrew Allen, M.D., Ph.D., has highlighted the significance of this approach, emphasizing that “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 substantial $433 million contract aligns with the overarching mission of the U.S. Department of Health and Human Services Project NextGen, which is focused on expediting the development of new vaccines and therapeutics capable of offering enhanced protection against COVID-19. This initiative has recently witnessed numerous contracts being awarded, including a notable commitment of $326 million to Regeneron for advancing its next-generation monoclonal antibody for combating COVID-19.
Gritstone Bio is predominantly recognized for its groundbreaking work in the field of cancer vaccines. The company’s lead program, GRANITE, is currently in the phase 2/3 trial stage for metastatic, microsatellite-stable colorectal cancer. While this contract signifies validation for Gritstone’s approach in COVID-19, industry experts believe that the GRANITE trial, slated to provide results in the first quarter of 2024, remains the company’s most pivotal milestone from an investor’s standpoint.
As the company progresses with its innovative CORAL program, the global scientific and medical community eagerly anticipates the results that could potentially reshape our understanding of COVID-19 vaccination and protection. Furthermore, Gritstone’s involvement in Project NextGen underscores the government’s commitment to fostering innovation in the fight against this global health crisis.
