January 19, 2021: ConserV Bioscience Limited (“ConserV”), a clinical-stage biotechnology company focused on developing vaccines that protect against endemic and emergent infectious diseases and Lawrence Livermore National Laboratory (“LLNL”) have agreed to collaborate on the development of a broad-spectrum coronavirus vaccine.
This collaboration brings together ConserV’s expertise in identifying antigens and Lawrence Livermore National Laboratory’s nanolipoprotein particle technology (“NLP”) delivery system.
The vaccine has been designed to provide broad-spectrum protection against coronavirus pathogens of human and animal origin, including but not limited to MERS, SARS and SARS-CoV-2.
The vaccine construct consists of conserved immunoreactive regions from external and internal coronavirus proteins, from each virus genus, encoded in messenger RNA (mRNA).
The mRNA constructs will be formulated with Lawrence Livermore National Laboratory ’s proprietary NLP vehicle prior to injection, allowing freeze drying of both components separately, improving storage and transport conditions required compared to other mRNA vaccine products.
Vaccine formulation was funded by the Department of Health and Social Care (DHSC) through an SBRI programme managed by Innovate UK.
The objective of the collaboration is to demonstrate the immunogenicity and protective responses in pre-clinical studies which will support initiation of clinical studies as soon as feasible thereafter.
To date, globally, over 92 million people have been infected by the SARS-CoV-2 virus and more than 1.9 million people have died from the infection (coronavirus.jhu.edu).
Genomic analysis of SARS-CoV-2 indicates that the virus accumulates two mutations a month and, in December 2020, a new variant (B.1.1.7 lineage) has emerged in the UK showing significant mutations in the spike protein and the receptor binding domain that drastically increases its infectivity.
Another variant that originated in South Africa, B.1.351 lineage (a.k.a. 501Y.V2), carries a mutation in the spike protein (E484K) that has been shown to reduce antibody recognition and could therefore affect the efficacy of the licensed vaccines.
A new variant belonging to the B.1.1.248 lineage has recently been detected in Japan in patients travelling from Brazil.
This strain has 12 mutations in the spike protein, including N501Y and E484K, implicated to increase transmissibility.
In Brazil, a variant with mutation E484K and closely resembling B.1.1.248 was reported on January 6, 2021 in a patient that had been reinfected with SARS-CoV-2.
Further investigations are needed to understand the impact of these new strains on transmission, clinical severity of infection, laboratory diagnostics, therapeutics, vaccines, or public health preventive measures.
In 2003, more than 8,000 people were infected by SARS-CoV-1 and at least 770 people died from the virus causing SARS.
In 2012, MERS-CoV was first identified and outbreaks emerged in 2015 and 2018 and, to date, approximately 2,500 people have been infected and over 850 people have died from MERS.
Considering the demonstrated pandemic potential and high mortality rates of some coronaviruses, a broad-spectrum vaccine is a necessary next step to protect against continued mutations of SARS-CoV-2 as well as against the likely emergence of new strains that jump from other hosts to humans posing new pandemic threats.
Kimbell Duncan, CEO of ConserV Bioscience, commented: “Our mission is to develop safe and effective vaccines which offer broad protection against infections from viruses that mutate frequently.
We are pleased to be working with Lawrence Livermore National Laboratory to develop our broad-spectrum coronavirus vaccine candidate.
We have identified regions within the proteins of the virus that are not susceptible to change and, if effective, the vaccine promises to protect against a broad spectrum of current circulating coronavirus strains and future emergent ones.”
Amy Rasley, Senior Scientist Immunology and Vaccines at Lawrence Livermore National Laboratory, added: “We look forward to combining our nanolipoprotein particle technology with ConserV’s mRNA construct encoding conserved viral epitopes. We hope to advance the vaccine candidate to human trials as quickly as possible.”
Nick Fischer, Principal Investigator on the project, noted: “Our NLP technology is very versatile, so we anticipate that we can tune our platform formulation to produce safe and effective vaccine candidates.” Other LLNL team members include Wei He, Matthew Coleman and Sandra Peters.
ConserV Bioscience has a pipeline of eight vaccines at various stages of pre-clinical and clinical development including a broad-spectrum flu vaccine that is ready to enter Phase III trials, to assess protective efficacy and safety, and a novel mosquito saliva vaccine that aims to protect against all mosquito-borne diseases that is ready to enter Phase II trials, to obtain preliminary information about the vaccine’s ability to produce its desired effect and continue to assess its safety.”
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