After Gritstone bio nabbed $433 million in federal funds to test its next-generation COVID-19 vaccine candidate, the planned phase 2b trial will get a late start thanks to a manufacturing-related delay. On the flip side, the company believes the delay should add to the trial's regulatory value.
The study was originally slated to kick off during this year’s first quarter, but it will now launch during the fall in order to “allow use of fully GMP-grade raw materials," the company disclosed in a press release. GMP is the acronym for good manufacturing practice, which are a group of regulations that govern drug production standards.
“The change likely increases the regulatory value of this large study, is expected to improve study interpretability, and may enable us to contemporaneously address the latest seasonal variant,” Gritstone co-founder and CEO Andrew Allen, M.D., Ph.D., said in the release.
The move was made after “recent communication” with the FDA and input from the Biomedical Advanced Research and Development Authority (BARDA), Allen added.
BARDA contracted the 10,000-participant study in September as a part of its Project NextGen, which looks to speed up the development of new vaccines and therapies that can provide broader and stronger protection against COVID. Regeneron, among others, was also tapped for the project with a $326 million investment.
Gritstone’s candidate, called CORAL, differs from traditional mRNA vaccines because of its self-amplifying technology.
The approach was designed to address the limitations of traditional first-generation mRNA COVID vaccines by “inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 variants,” Allen said in a prior release. With its upcoming study, Gritstone will test its candidate against an approved COVID vaccine.
Elsewhere, Gritstone bio is best known for its cancer vaccines. Its lead program, dubbed GRANITE, is in phase 2/3 testing for metastatic, microsatellite-stable colorectal cancer, with a readout expected soon.