Gritstone and CEPI Announce Agreement to Advance Second-Generation COVID-19 Vaccine Program (CORAL) Against SARS-CoV-2 Variants of Concern
- CEPI to fund Gritstone’s work on second-generation vaccines against SARS-CoV-2, the virus causing COVID-19, including a clinical trial in
South Africaand manufacturing optimization
- Gritstone’s second-generation vaccines include self-amplifying mRNA (SAM) to deliver multiple antigens (spike protein plus additional sequence from non-spike genes) providing the potential for deep, broad, and durable immunity against SARS-CoV-2 variants
- Gritstone’s CORAL Phase 1 program – which includes the CEPI-funded trial – is establishing optimal dosing and antigenic content in young individuals, the elderly, the previously vaccinated, and the immunocompromised, including people living with HIV
“COVID-19 variants are already rendering some of our vaccines less effective, so it is critical that we don’t let our guard down: we must continue to invest in critical vaccine R&D if we are to stay one step ahead of this deadly virus,” said
“Our unique approach combines our self-amplifying mRNA platform with a broad set of viral antigens beyond spike intended to drive robust and durable immune responses comprising both neutralizing antibodies and CD8+ T cells. With this unique antigenic breadth, our CORAL vaccine may offer protection against emerging spike variants of SARS-CoV-2 that appear challenging for first generation vaccines,” said
Under the terms of the agreement, CEPI will fund a multi-arm Phase 1 study evaluating the CORAL program’s SAM vaccine in naïve, convalescent, and HIV+ patients. The funding will also support pre-clinical studies, scale-up and formulation development to enable more stable drug product. The study will evaluate two different SAM vaccine constructs that each target both the spike protein and other SARS-CoV-2 targets and are designed to drive both robust B and T cell immune responses. The trial is expected to initiate before the end of 2021.
CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone bio have agreed that this vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.
About the CORAL Program
Gritstone’s CORAL program is a second-generation SARS-CoV-2 vaccine platform delivering spike and additional SARS-CoV-2 T cell epitopes, offering the potential for deep, broad, and durable protection against SARS-CoV-2 variants. Delivery vectors can comprise a chimpanzee adenovirus, self-amplifying mRNA or both. The program is supported by several key relationships:
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on
Chief Financial Officer