Manufacturing Trial for Gritstone's BARDA-funded COVID-19 vaccine delayed due to...

Trial for Gritstone’s BARDA-funded COVID-19 vaccine delayed due to production issues

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Gritstone Bio has secured a substantial sum of $433 million in federal funding earmarked for the testing of its cutting-edge COVID-19 vaccine. However, a setback has emerged as a delayed commencement of its phase 2b trial, attributed to manufacturing issues. 

Nonetheless, the company views this delay as potentially advantageous, potentially elevating the trial’s regulatory significance. Initially slated for the year’s first quarter, the trial’s start has been rescheduled to the fall to integrate fully GMP-grade raw materials, a detail unveiled in a press release. GMP, standing for good manufacturing practice, denotes a series of standards governing drug production.

Gritstone Bio is a bio firm that specializes in cancer immunotherapy and creates customized cancer treatments for the next generation. To address fundamental difficulties at the nexus of cancer genomes, immunology, and immunotherapy design, Gritstone brings together eminent scientific founders, seasoned and successful board of directors, an experienced and varied management staff, and substantial financial backing. To create innovative lung cancer treatments, the company’s initial objective is to locate and utilize therapeutic neo-antigens from each patient’s tumor.

Andrew Allen, Gritstone’s co-founder and CEO, believes that the delay, spurred by recent dialogues with the FDA and insights from BARDA (the Biomedical Advanced Research and Development Authority), could fortify the trial’s regulatory stature and interpretability. BARDA initiated the 10,000-participant study under Project NextGen in September, to expedite the development of more potent COVID vaccines and therapies. Other participants in this endeavor include Regeneron and other entities, with Regeneron’s investment amounting to $326 million.

Gritstone’s vaccine candidate, CORAL, distinguishes itself from conventional mRNA vaccines due to its utilization of self-amplifying technology. This innovative approach seeks to address the limitations observed in first-generation mRNA COVID vaccines by eliciting robust neutralizing antibody and T cell-based immunity against both current and future variants of SARS-CoV-2, as elucidated by Allen in a prior statement. In its forthcoming trial, Gritstone intends to juxtapose its candidate against an already approved COVID-19 vaccine.

Outside the realm of COVID-19, Gritstone has garnered recognition for its endeavors in cancer vaccines, notably its flagship program GRANITE, which is presently undergoing phase 2/3 trials targeting metastatic, microsatellite-stable colorectal cancer.

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