BARDA Funds Gritstone Bio's Phase 2b Study for Covid-19 Vaccine Candidate
US biotechnology company Gritstone Bio has received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating the company’s self-amplifying mRNA (samRNA) vaccine candidate against Covid-19.
The contract, worth up to $433 million, was awarded as part of Project NextGen, a US Department of Health and Human Services (HHS) initiative to advance a pipeline of new, innovative vaccines and therapeutics that provide broader and more durable protection for Covid-19.
Under the agreement, Gritstone Bio will conduct a randomized, double-blind, Phase 2b study with 10,000 participants to compare the efficacy, safety and immunogenicity of the company's next-generation Covid 19 vaccine candidate to an approved Covid 19 vaccine. Preparations for the study are underway, and conduct of the study is fully funded by BARDA.
Gritstone said that it will run the study in the United States in collaboration with the Covid-19 Prevention Network (CoVPN), a NIAID-supported network of clinical trial sites based at Fred Hutchinson Cancer Center with experience conducting large Covid-19 vaccine trials.
The start of the Phase 2b study is expected in the first quarter of 2024.
“We are honored to receive this award from BARDA to advance our next-generation samRNA vaccine against Covid-19 (the Coral program), which provides strong validation of our innovative vaccine platform in infectious diseases. Not only does this contract supply the necessary resources to advance the development of Coral, but it also signifies the trust and confidence the U.S. government has placed in our novel vaccine approach,” said Andrew Allen, co-founder, president and CEO of Gritstone Bio. “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,” Allen added.
According to Gritstone Bio, its samRNA vaccine, which contains both Spike and other viral targets (Spike plus), has shown in multiple Phase 1 studies to elicit strong immune responses and has the potential to provide broad and durable clinical protection.
