CEPI to provide up to US$20.6 million in funding
Funding will support development of a self-amplifying mRNA vaccine candidate against COVID-19 variants
Programme forms part of CEPI’s efforts to develop “next-generation” COVID-19 vaccines
August 17, 2021; Oslo, Norway—CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it entered into a funding agreement with Gritstone bio, Inc. to advance development of a self-amplifying mRNA vaccine candidate against COVID-19 variants. CEPI will provide up to US$20.6 million to support a phase 1 clinical trial, including manufacturing of clinical trial materials as well as supporting preclinical studies and optimisation of manufacturing processes.
This funding forms part of CEPI’s programme to develop “next-generation” COVID-19 vaccines that are differentiated from those already in advanced development and can be used against COVID-19 variants. CEPI’s portfolio of “next-generation” vaccines currently includes SK bioscience’s nanoparticle vaccine candidate (GBP510), the University of Hong Kong’s intranasal vaccine candidate, VBI Vaccines’ virus-like particle candidate, and ZerunBio’s recombinant vaccine candidate.
Self-amplifying mRNA vaccines
As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body.
However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself—the self-amplification machinery.
The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine. Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein, and could potentially provide broad protection against other SARS-CoV-2 strains.
“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. CEPI is planning for the longer-term management of COVID-19 by investing in vaccines to address the threat of variants, and I’m pleased to work with Gritstone to advance the development of this innovative vaccine candidate, which can be made globally accessible through COVAX if it is proven to be safe and effective.”Dr. Richard Hatchett
Chief Executive Officer, CEPI
Enabling equitable access
CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone 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.
“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. We are honored to be supporting CEPI in their mission to help find new vaccines solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.”Dr Andrew Allen
Co-founder, President and CEO of Gritstone
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at https://endpandemics.cepi.net.
About Gritstone bio
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGETM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and, second, the ability to develop and manufacture potent immunotherapies utilizing these antigens to potentially drive the patient’s immune system to specifically attack and destroy disease-causing cells. The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off-the-shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine, with support from departments within the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and through a license agreement with La Jolla Institute for Immunology. Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences. For more information, please visit gritstone.com.
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 more durable protection and broader immunity 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: La Jolla Institute for Immunology, Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Disease (NIAID), and the Coalition for Epidemic Preparedness Innovations (CEPI). A phase one clinical trial is currently being sponsored by NIAID examining the reactogenicity and immunogenicity of CORAL in healthy volunteers, both young and elderly. Gritstone is sponsoring and conducting its own Phase 1 studies in select populations. Together with the study supported by CEPI, this set of clinical trials will test four different vaccine candidates and establish optimal dosing and antigenic content for the CORAL program in young subjects, the elderly, the previously vaccinated, and the immunocompromised (who typically respond poorly to current EUA vaccines).
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by CEPI, Gavi, the Vaccine Alliance Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.
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