CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its partnership with Sichuan Clover Biopharmaceuticals, Inc (China) ("Clover") to rapidly advance the development and manufacture of Clover's protein-based COVID-19 S-Trimer vaccine candidate, which is based on Clover's proprietary Trimer-Tag© vaccine technology platform.
CEPI will make an additional investment of $66m upfront in S-Trimer which will immediately fund preclinical studies, the execution of Phase 1 clinical trials, and preparation of sites globally for an efficacy trial. In parallel, this investment will support scale up of Clover's manufacturing capacity to potentially allow the production of hundreds of millions of doses per year. The results of these clinical trials and initial manufacturing scale-up activities will inform planning for efficacy trials and full manufacture of the vaccine. If the early stage clinical development is successful, the partnership agreement anticipates CEPI providing significant additional investment which will fully fund the S-Trimer vaccine candidate through to licensure in China and globally.
This agreement builds on CEPI's initial partnership with Clover, announced in April 2020, which supported the preparations and initiation of a Phase 1 clinical trial of the vaccine candidate which began enrolling participants on 19 June 2020.
Clover is exploring development pathways for the S-Trimer vaccine to be made accessible to populations in China and globally, if it is proven to be safe and effective. In line with CEPI's commitment to equitable access, under the terms of the agreement it is anticipated that vaccine output funded by CEPI's investment will be procured and allocated through the COVID-19 Vaccine Global Access (COVAX) Facility1. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.
Dr. Richard Hatchett, CEO of CEPI said:
"The expansion of our partnership with Clover is an important step forward in our efforts to develop a safe, effective and globally accessibly vaccine against COVID-19. Clover's S-Trimer is a promising vaccine candidate with the potential to be scaled up to produce hundreds of millions or even one billion doses per year, so it could play a significant role in controlling this pandemic. CEPI's investment will fund clinical development and initial manufacturing scale up activities in parallel, with the aim of greatly compressing timelines so that if the vaccine is proven to be safe and effective it can be given to those who most need it as soon as possible."
Nick Jackson, Head of Programmes and Innovative Technology at CEPI, and the Chief Representative of CEPI's Shanghai Representative Office said:
"Our collaboration with Clover exemplifies CEPI's mission in China to seek cooperation in the prevention and control of pandemic diseases, including the funding of public health research projects, research and development of vaccines, and international scientific, technology and development partnerships and exchanges."
Joshua Liang, CEO of Clover and co-inventor of COVID-19 S-Trimer vaccine candidate said:
"We are honoured to receive CEPI's continued recognition and support, which follows several months of close collaboration. With CEPI's additional investment and funding commitment, Clover intends to further accelerate the development of S-Trimer including preparing for a global efficacy trial. More than ever, Clover remains focused on developing a safe, effective and accessible COVID-19 vaccine at a scale that could contribute to the control of the pandemic globally."
Dr. Peng Liang, Founder and Chairman of Clover and inventor of Trimer-Tag© technology added:
"Global cross-border collaborations during times like these are crucial for the successful and timely development of safe and effective vaccines which are important to ending this pandemic. As a China headquartered company, Clover is proud to expand our collaboration with CEPI with a clear objective of producing and supplying our S-Trimer vaccine to China and the world."
In addition to CEPI's partnership with Clover, the organization has provided support and funding to develop COVID-19 vaccine candidates to CureVac, Inc., Inovio Pharmaceuticals, Inc., Moderna, Inc., Novavax, Inc., The University of Hong Kong, The University of Oxford/ AstraZeneca, The University of Queensland/ CSL and a consortium led by Institut Pasteur2.3,4,5,6
CEPI recently officially announced that it has opened a Representative Office in Shanghai. Through its Shanghai Representative Office, CEPI is seeking to cooperate broadly in China on COVID-19 vaccine development and build robust collaborations to prevent and control other potential infectious disease outbreaks in the future.
COVID-19 S-Trimer vaccine
Utilizing Clover's proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system.
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 nine partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships.
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 Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. Having raised more than US$ 200 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house GMP biomanufacturing capabilities to support large-scale production of its biologic therapies. For more information, please visit our website:? www.cloverbiopharma.com
1 The COVAX Facility is an instrument of the COVAX pillar of the ACT Accelerator within which CEPI works in partnership with Gavi and the World Health Organisation
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