GRTS - Presentations at IDWeek 2023 Highlight Potentially Differentiated Immunogenicity of Gritstone bio's Next Generation COVID-19 Vaccine | Benzinga
-- High neutralizing antibody (nAb) responses sustained through at least 12 months, highlighting potential for durable clinical protection --
-- T cell responses to Spike plus other viral targets observed in all Phase 1 studies, demonstrating broad and potentially variant-proof immune response --
-- Over 300 subjects dosed to date across Phase 1 studies; vaccine tolerability appears comparable to approved COVID-19 vaccines --
-- Head-to-head Phase 2b study evaluating Gritstone's self-amplifying mRNA with approved vaccine for COVID-19 expected to initiate in 1Q 2024 --
EMERYVILLE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- October 11, 2023 (GLOBE NEWSWIRE) – Gritstone bio, Inc. (NASDAQ:GRTS), a clinical-stage biotechnology company working to develop the world's most potent vaccines, today announced the presentation of results from three ongoing Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company's CORAL program) at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.
Gritstone will present further follow up data from the CORAL-CEPI and CORAL-BOOST studies (most recent prior presentation in April 2023, press release). Representatives from the Infectious Diseases Clinical Research Consortium (IDCRC), a clinical trials network established by the National Institute of Allergy and Infectious Disease (NIAID), will present the first results from the CORAL-NIH study, a Phase 1 study conducted by IDCRC and supported by NIAID). Results across these studies generally reaffirm and extend previous CORAL findings that Gritstone's next-generation samRNA-based approach, which incorporates both Spike and other viral targets ("Spike plus"), can induce potent and durable immune responses with potential to drive broad and long-lasting clinical protection.
"The findings presented at IDWeek highlight the potential of our self-amplifying mRNA vaccine to address the limitations of today's approved vaccines against COVID-19 and provide additional clinical rationale for our novel ‘spike-plus' approach as we advance into a large head-to-head study," said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. "These data reaffirm previous findings that our samRNA vaccines have the potential to drive highly durable antibody responses, to enhance immunity through broader T cell responses, and to accomplish this at RNA doses as low as 3 micrograms, one tenth the dose of currently approved mRNA vaccines for COVID-19. The collective data showing that elicited neutralizing antibody titers persist at high levels for at least 12 months – data shared for the first time during IDWeek 2023 – are particularly exciting and further validate the rapid ongoing advancement of the CORAL program. Preparations for the BARDA-funded, 10,000 subject Phase 2b, head-to-head study are underway, having entered the base period, and we look forward to initiating the study in the first quarter of 2024."
Key Highlights from IDWeek Poster Presentations:
CORAL-CEPI and CORAL-BOOST presentations (presented by Gritstone)
CORAL-CEPI Presentation (Abstract 1538194, Poster Presentation): Durable Immune Response Induced by Self-amplifying mRNA (samRNA) SARS-CoV-2 Vaccine Candidates in Vaccine-naïve HIV Negative and People Living with HIV (PLWH) Populations
Date/Time: Saturday, Oct 14, 2023, 12:15 - 1:30 PM
Poster #: 2372
Presenter: Atul Nagare, MD
Location: BCEC Poster Hall
CORAL-CEPI (NCT05435027) is a Phase ...