London, United Kingdom and Livermore, California, 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.
ConserV Bioscience Limited, based in Oxfordshire, United Kingdom, is a clinical-stage vaccine development company focused on advancing safe and effective vaccines that protect against endemic and emergent infectious diseases. Founded in 2020 as a spin-out from Seek (Peptcell Limited), it has an experienced scientific and leadership team. It is harnessing its novel in silico proprietary platform to identify highly conserved regions of viral proteins that contain a high number of reactive T-cell epitopes with extensive HLA coverage. In addition to its broad-spectrum coronavirus vaccine candidate, its pipeline includes vaccine candidates to protect against broad-spectrum influenza, mosquito-borne diseases, HIV, Hepatitis C, Hepatitis B, Rotavirus and Chagas. www.conservbio.com
Lawrence Livermore National Laboratory, based in Livermore, California, is a US government-owned facility that is part of the Department of Energy. Its mission is to strengthen US security through the development and application of world-class science and technology. The Biosciences and Biotechnology division applies an understanding of fundamental biology to predict and counter emerging biological and chemical threats and to solve problems in health and environmental security.
NLPs are water-soluble molecules that are 6 to 30 billionths of a meter in size resembling high-density lipoprotein (HDL) particles, which are associated with playing a role in regulating the human body’s ‘good’ cholesterol. LLNL scientists are working to use this nanotechnology, also known as nanodiscs, as a delivery platform for tularemia and chlamydia vaccines that are under development.
Innovate UK, the UK’s innovation agency, drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. We connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth. We fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions.
The Small Business Research Initiative programme uses the power of government procurement to drive innovation. It provides opportunities for innovative companies to engage with the public sector and gain contracts to solve specific problems. Competitions for new technologies and ideas are run on specific topics and aim to engage a broad range of organisations. SBRI enables the public sector to engage with industry during the early stages of development, supporting projects through the stages of feasibility and prototyping. https://www.gov.uk/government/collections/sbri-the-small-business-research-initiative