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CEPI Funding Covid-19 Variant Vaccine

SARS-CoV-2 particle

Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient. (NIAID, NIH)

19 Aug. 2021. A biotechnology company is advancing a vaccine to protect against disease from SARS-CoV-2 variants, with new support from the organization CEPI. Gritstone Bio Inc. in Emeryville, California is receiving $20.6 million from CEPI, short for Coalition for Epidemic Preparedness Innovations in Oslo, Norway, with the next clinical trial of the vaccine expected in South Africa.

Gritstone Bio creates treatments for cancer and vaccines for infectious diseases with its immunology platform based on a specific DNA composition of target cells called neo-antigens. The company first created its technology, called Edge, for cancer to evaluate DNA from each patient’s tumor using genomic sequencing and bioinformatics to identify individual tumor-specific neo-antigens. Gritstone then applies its own algorithms with artificial intelligence to identify the most likely neo-antigens to activate an immune response, and delivers personalized synthetic neo-antigens for the patient as a vaccine, either on their own or with other therapies. Among Gritstone’s own treatments are T-cell receptors, naturally occurring proteins modified to target other characteristic proteins on the surface of a target virus or cancer cells.

For Covid-19 vaccines, Gritstone applies its technology to targets on the SARS-CoV-2 virus responsible for Covid-19 infections. The company licensed from La Jolla Institute for Immunology validated epitopes, binding sites for antibodies and T-cells on antigen proteins recognized by the immune system, for SARS-CoV-2 viruses. La Jolla Institute derived the epitopes from analyzing hundreds of recovering Covid-19 patient blood samples. With those epitopes and neo-antigens, Gritstone’s Covid-19 vaccine, called Coral, generates a dual response, first a prime immune response, then a supplemental boost from self-amplifying messenger RNA, or mRNA.

“Our unique approach,” says Gritstone co-founder and president Andrew Allen in a company statement, “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.” Allen adds, “our Coral vaccine may offer protection against emerging spike variants of SARS-CoV-2 that appear challenging for first generation vaccines.”

Testing two self-amplifying mRNA formulations

As reported by Science & Enterprise in January, Gritstone focuses its Covid-19 vaccine on emerging variants from mutations in the SARS-CoV-2 virus. The company’s early support for the multi-variant vaccine came from the Bill & Melinda Gates Foundation and National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.

The new CEPI funds support preclinical research, scale-up, and formulation of a more stable vaccine. The funds also finance an early-stage clinical trial of the vaccine in South Africa, among participants receiving a vaccine for the first time, people recovering from Covid-19 infections, and individuals living with HIV, who make up a sizable portion of the population. The trial is expected to test two formulations of self-amplifying mRNA targeting the SARS-CoV-2 spike protein and other parts of the virus, to generate antibody and T-cell responses.

“Covid-19 variants are already rendering some of our vaccines less effective,” notes Richard Hatchett, CEPI’s CEO in an organization statement, “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 also a major supporter of the Covid-19 Vaccine Global Access or Covax Facility that aims to provide worldwide equitable access to Covid-19 vaccines. Gritstone agreed to make its Coral vaccine available to Covax, if shown to be safe and effective.

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