CEPI and SK bioscience expand partnership to advance multiple COVID-19 variant vaccines and scale-up manufacturing
CEPI to provide up to US$173.4 million of additional funding to SK bioscience for its COVID-19 vaccine programme.
Funding will support Phase 3 trials of SK bioscience's recombinant protein vaccine candidate (GBP510) and adaptation for use against multiple variants of concern.
Funding will also support manufacturing scale-up to potentially hundreds of millions of doses per year.
24 May, 2021; Oslo, Norway—CEPI, the Coalition for Epidemic Preparedness Innovations, and SK bioscience today announced an expanded partnership to develop a vaccine candidate against SARS-CoV-2, including variants of concern. CEPI will provide up to US$173.4 million in additional funding to SK bioscience to support its COVID-19 vaccine development programme. Of this funding, $41 million will be provided in the form of a forgivable loan that is repayable based on sales of the vaccine and will be used to secure raw materials needed for manufacturing. This brings CEPI's total investment in SK bioscience to $210.1 million.
CEPI's funding will support Phase 3 clinical trials of SK bioscience's recombinant protein vaccine candidate (GBP510). The GBP510 candidate—which is currently undergoing Phase 1/2 testing in the Republic of Korea—is manufactured using a nanoparticle platform.
In response to the threat posed by SARS-CoV-2 variants, CEPI will also be funding further adaptation and clinical testing of the GBP510 candidate for use against variants of concern, such as the B.1.351 variant (first identified in South Africa). In parallel, CEPI will also support further scale-up of SK bioscience manufacturing to full commercial scale, potentially enabling the annual production of hundreds of millions of doses.
CEPI previously invested up to $10 million towards the cost of Phase 1/2 trials of in SK bioscience's vaccine candidate in December 2020, followed by an additional $26.7 million to begin adaptation against variants and support scale-up of manufacturing in March 2021.
The whole world is at risk of the emergence of novel SARS-CoV-2 variants. As we have seen with the B.1.1.7 and B.1.617 variants–first identified in the UK and India respectively–they can arise without notice, spread rapidly, and cause tremendous disruption. Many of the variants of concern that we know about are rendering our vaccines less effective, so it is critical that we do not let our guards down.
We must protect the precious progress we have made over the past year by continuing to invest in crucial R&D so that we can adapt our vaccines, ideally within 100 days, in response to the threat posed by these variants. Tackling COVID-19, and its variants, is a core part of CEPI's longer-term plans to substantially reduce, and eventually eliminate, the risk of epidemic and pandemic diseases. I'm pleased to expand CEPI's partnership with SK bioscience to further strengthen the world's ability to control this deadly disease.
Race against viral mutation
The virus that causes COVID-19 is constantly mutating. Variant B.1.1.7 (first identified in the UK) is up to 70% more transmissible than the virus that emerged in Wuhan and there are concerns that another coronavirus variant, B.1.617, first identified in India, could be even more transmissible. To date, CEPI has invested in two vaccine candidates to tackle variants of concern, which can be made globally accessible through COVAX. It also has an open funding call to advance development of broadly protective coronavirus vaccines against SARS-CoV-2 and Betacoronaviruses, like SARS and MERS.
It is a great pleasure to expand collaboration with CEPI advancing the GBP510 development including variants. The wholehearted support of CEPI and Gates Foundation reflects the technological level and potential value of our vaccine candidate. We are also pursuing the development cooperating closely with relevant international regulatory agencies, as well as Korean pan-government support group and MFDS. To achieve the goal against the pandemic, we will continue our highest efforts for the successful development and enlarged access to the COVID-19 vaccine that can also be preventive to variants utilizing our expanded manufacturing capabilities.
Equitable access key to ending acute phase of pandemic
SK bioscience and CEPI are committed to enabling global equitable access to COVID-19 vaccines and have agreed that hundreds of millions of doses of this vaccine candidate will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if proven to be safe and effective. To date, 68 million COVAX doses have already been delivered to 124 participating economies, with the aim of distributing 2 billion doses globally in 2021.
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The GBP510 vaccine candidate
The vaccine candidate is a recombinant-protein vaccine based on a novel two-component self-assembling nanoparticle developed at the Institute for Protein Design (IPD) at the University of Washington.
The vaccine is made up of two components, A and B. Component A is a recombinant protein comprised of a portion of the SARS-CoV-2 Spike protein, known as the receptor binding domain (RBD). The RBD is the part of the Spike that enables the virus to bind to and infect human cells.
Component A proteins are then attached to the surface of component B, a "central core" nanoparticle. The combination of these two components results in the optimum exposure of the RBD antigen, which is then recognised by the immune system.
Potential advantages of this candidate include scalability, thermostability, and possible use as a platform to develop vaccines against future unknown pathogens, referred to as Disease X. Additionally, preclinical studies of this vaccine candidate have shown that it induces very high titres of neutralising antibodies.
SK bioscience has advanced the development of their vaccine candidate using its established process platforms and corresponding commercial Good Manufacturing Practice (GMP) capabilities. SK bioscience started Phase 1/2 studies of GBP510 early in 2021.
About CEPI
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 endpandemics.cepi.net.
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About COVAX
COVAX is the vaccines pillar of the ACT-Accelerator. It is co-led by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization (WHO) with lead delivery partner UNICEF, working in partnership with developed and developing country vaccine manufacturers, the World Bank, Civil Society Organisations and others. COVAX is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to economies of all financial means.
About SK bioscience
SK bioscience is an innovative South Korean biopharmaceutical company specialized in the vaccine area. SK bioscience developed the cell-culture based influenza vaccine named SKYCellFluTM prequalified by WHO in 2019, SKYZosterTM, the world's second vaccine for shingles, and SKYVaricellaTM, the world's second WHO prequalified varicella vaccine for chickenpox. By leveraging the company's strengths on cutting-edge vaccine development technologies, SK bioscience has been expanding its R&D portfolio including pneumococcal conjugate vaccine, human papillomavirus vaccine, typhoid conjugate vaccine and non-replicating rotavirus vaccine through in-house development or external partnership with public and private institutions around the globe pursuing global health. For the COVID-19 vaccine response, SK bioscience is undergoing development for its vaccine candidate against SARS-CoV-2 with support from the Bill and Melinda Gates Foundation and CEPI, and using its established development and manufacturing capabilities, it has been cooperating to develop and manufacture AstraZeneca's and Novavax's COVID-19 vaccine candidates.
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