Gritstone bio Announces Publication of Interim Results from Phase 1 Study of Self-amplifying mRNA (samRNA) Vaccine Against COVID-19 in Nature Communications

— Potent and durable immunogenicity achieved with low dose self-amplifying mRNA vaccine (samRNA) candidate —

— Immunity boosted for at least 6 months in previously vaccinated-older adults (administration post-primary series of Vaxzevria®, Comirnaty® or Spikevax®) —

— Data underscore the potential of Gritstone’s samRNA candidates to serve as next-generation vaccines against COVID-19 and other infectious diseases –

Excerpt from the Press Release:

EMERYVILLE, Calif., June 08, 2023 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against COVID-19 (CORAL-BOOST) were published in Nature Communications. The results, which demonstrate that Gritstone’s samRNA vaccine candidate boosted immunity for at least 6 months in previously vaccinated older adults, are generally consistent with initial results from a separate Phase 1 study in previously unvaccinated subjects (CORAL-CEPI). Gritstone is currently evaluating multiple samRNA candidates across three ongoing Phase 1 studies. All candidates deliver full-length Spike and selected conserved non-Spike T cell epitopes with the aim of driving a potent, broad, and durable immune response against the virus.

“Publication of these results in Nature Communications supports the scientific rigor of our work and potential clinical utility of our next-generation vaccine platform for the prevention of infectious diseases, including coronaviruses, such as COVID-19,” said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. “The published results are part of a rapidly growing body of evidence demonstrating the potential advantages of samRNA over first-generation COVID-19 vaccines, including extended antigen expression and dose sparing potential. It’s clear that new technologies are needed to help prevent and manage future pandemics, and we believe the results we are seeing from our CORAL program represent a promising step forward in this endeavor.”

The publication details interim analyses from a Phase 1 dose-escalation trial evaluating Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults (CORAL-BOOST/NCT05148962). Results demonstrate a favorable safety and tolerability profile in this vulnerable population. Most adverse events (AEs) following dosing were mild to moderate and transient with no treatment-related serious AEs observed. With respect to immunogenicity, neutralizing antibody titers against ancestral Spike and variants of concern were boosted by the samRNA candidate, and contrasting to authorized vaccines, persisted through at least 6 months following the booster dose. Furthermore, Gritstone’s samRNA increased and potentially broadened functional Spike-specific T cell responses and primed T cell responses to conserved non-Spike epitopes.

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