Gritstone Bio, a US company, has announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded the company a contract valued up to $433m to evaluate its mRNA vaccine, samRNA, as a candidate for COVID-19.
The agreement was awarded as part of the US Department of Health and Human Services (HHS) initiative, Project NextGen, to advance new, innovative vaccines and therapeutics to provide broader and more durable protection against COVID-19.
As part of the agreement, the clinical-stage biopharmaceutical company, Gritstone, will conduct a phase 2b double-blinded study, the CORAL programme, which will include 10,000 participants, to compare the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate with an approved COVID-19 vaccine.
The CORAL programme was designed to address the limitations of protection against SARS-CoV-2 variants by inducing durable neutralising antibodies and T cell-based immunity against current and future strains.
The samRNA vaccine, which incorporates both spike and other viral targets, has previously shown potent immune responses as well as the potential to drive broad and durable clinical protection against COVID-19.
In comparison to other traditional mRNA vaccines, samRNA creates several copies of the antigen RNA once in the cell, potentially providing an extended duration and magnitude of antigen expression.
The study will be fully funded by BARDA and will take place in the US in collaboration with the COVID-19 Prevention Network (CoVPN), a network supported by the National Institute of Allergy and Infectious Diseases (NIAID).
Ahead of the phase 2b study, Andrew Allen, co-founder, president and chief executive officer of Gritstone said that the company is “excited… to work alongside BARDA and look forward to initiating the phase 2b study (CORAL-BARDA) in the first quarter of 2024”.
“With CORAL moving into a randomised phase 2 study alongside our personalised cancer vaccine program (GRANITE), Gritstone now sits at the precipice of unlocking the full potential of our novel vaccine platforms in both oncology and infectious diseases,” he added.