09 Dec 2020
CEPI, the Coalition for Epidemic Preparedness Innovations, today announced a collaboration with South Korea-based SK bioscience to advance the development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. CEPI will contribute up to $10 million towards the cost of a phase I/II study of a recombinant protein vaccine candidate (GBP510)—manufactured using a nanoparticle platform—and manufacture of clinical trial materials needed for phase I/II and phase III trials. This collaboration represents CEPI’s first next-generation or ‘Wave 2’ vaccine investment, jointly funded by CEPI and the Bill & Melinda Gates Foundation. In November 2020, CEPI received a grant of up to $20 million from the Foundation to expand its portfolio of COVID-19 vaccines to include ‘Wave 2’ candidates that are differentiated from those already in advanced development. CEPI’s COVID-19 work is supported by multiple governments, philanthropies, and private-sector entities.
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 is planning to start a phase 1/2 study before the end of 2020.
SK bioscience and CEPI are committed to global equitable access of COVID-19 vaccines and have agreed that this vaccine candidate will be made available for procurement and allocation, if proven to be safe and effective, through the COVID-19 Vaccine Global Access (COVAX) Facility. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.
Chief Executive Officer, CEPI
The need for ‘Wave 2’ vaccines
COVID-19 will likely become endemic and while the speed of vaccine development has been unprecedented, it’s critical that we continue to develop an approach that optimises vaccines and ensures suitability for the whole world. For example, we need to pursue vaccines that provide protection after a single dose, have improved temperature stability, have manufacturing scalability, and also have improved or differentiated immune responses. CEPI is, therefore, investing to accelerate the development of ‘Wave 2” or second generation, vaccines that could address these issues essentially ensuring availability of vaccines that are easier to deliver and address the specific needs of a diverse range of populations and settings.
CEO of SK bioscience
In a separate agreement, signed in August, CEPI reserved manufacturing capacity with SK bioscience to manufacture a COVID-19 vaccine candidate to be designated by CEPI. Novavax was the first vaccine developer to enter into a manufacturing agreement with SK bioscience, which will utilise the reserved capacity for the manufacturing and supply of Novavax’ COVID-19 vaccine candidate, NVX-CoV2373.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 10 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.
Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
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About CEPI’s COVID-19 vaccine programmes
Built on the principles of speed, scale and equitable access, CEPI is supporting the research and development of a diverse portfolio of vaccine candidates based on a range of vaccine approaches. Of the nine vaccine candidates in the CEPI portfolio prior to this announcement, eight have entered clinical trials out of 48 globally.
CEPI has raised US$1.3bn in support of COVID-19 vaccine research and development, but urgently needs $800m in additional funds to achieve its aim of developing three safe and effective vaccines which can be made globally available through COVAX. These funds are vital for CEPI to progress the most promising vaccine candidates in the portfolio through crucial late-stage clinical trials to prove their safety and efficacy, and ultimately to licensure.
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) – working in partnership with developed and developing country vaccine manufacturers, UNICEF, 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.
CEPI and the Republic of Korea
Since 2019, CEPI has held a partnering agreement with the International Vaccine Institute (IVI), headquartered in Seoul, Republic of Korea. The collaboration has supported the development of an international MERS reference standard alongside a programme to develop a Chikungunya vaccine candidate, led by a consortium of IVI and Bharat Biotech.
In addition to executing work on its target diseases, CEPI has moved quickly and in collaboration with partners, including those in the Republic of Korea, to respond to the COVID-19 pandemic. A Phase I/II clinical trial to assess CEPI-supported COVID-19 vaccine candidate under development by Inovio is being run in the Republic of Korea, in partnership with IVI and the Korea National Institute of Health (KNIH). CEPI has also partnered with bioscience facilities SK bioscience and GC Pharma to reserve manufacturing capacities exclusively for one or more CEPI-funded COVID-19 vaccines.
The efforts support CEPI’s goal alongside its COVAX partners, Gavi, the Vaccine Alliance, and the World Health Organization (WHO), to produce 2 billion doses of safe and effective COVID-19 vaccines by the end of 2021. The Republic of Korea is one of the 187 economies who are part of the COVAX initiative, with the nation also pledging funding to the Gavi COVAX Advance Market Commitment (AMC), a financing mechanism that will support 92 low- and middle-income economies’ access to safe and effective vaccines.
CEPI’s partnership and involvement in the Republic of Korea were this month highlighted by CEPI’s CEO, Richard Hatchett, at the 15th Jeju Forum for Peace and Prosperity – a virtual event held this year under the theme of ‘New Concept for Multilateral Cooperation: Pandemic Security’. A keynote speech was delivered at the opening ceremony of the Forum by Korea’s President Moon Jae-in.
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 recently agreed to develop and manufacture AstraZeneca’s and Novavax’s COVID-19 vaccine candidates.
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Phone: +44 7387 055214
SK bioscience Co., Ltd.
Email: [email protected]