Gritstone bio announced an approximately 40% reduction of its workforce, following the delay of a proposed phase 2 vaccine study.
Earlier this month, Gritstone revealed that its CORAL phase 2b study, a head-to-head trial of its next-generation COVID-19 vaccine, would kick off this coming fall, rather than in the first quarter of the year. The company said the delay was necessary in order to "allow use of fully GMP-grade raw materials in the vaccine," a change that Gritstone says will increase the regulatory utility of the trial.
Back in September Gritstone had been awarded a contract by BARDA to conduct a comparative study evaluating the company's self-amplifying mRNA (samRNA) vaccine candidate as part of a larger push to develop better COVID-19 vaccines. The agreement, which is valued at up to $433 million, was awarded as part of Project NextGen, an initiative by the U.S. Department of Health and Human Services.
Under the contract, Gritstone will conduct a 10,000 participant, randomized phase 2b double-blinded study to compare the efficacy, safety and immunogenicity of the Gritstone next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine.
The delay in the trial start, however, has resulted in Gritstone not receiving the external BARDA funding it previously anticipated beginning in the first quarter of 2024, which in turn triggered the workforce reduction.
Gritstone's innovative vaccine platform relies on self-amplifying mRNA, which the company says is rapidly emerging as a well-tolerated, scalable and widely-applicable platform technology. The technology can be used to develop multiple vaccines simply by changing the sequence of the antigen (the target) that is encoded in the vector RNA and delivered in a lipid nanoparticle. Unlike traditional mRNA, samRNA creates multiple copies of the antigen RNA once in the cell, which Gritstone says can lead to extended duration and magnitude of antigen expression.
