OSLO, Norway & CHENGDU, China--(BUSINESS WIRE)--CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate by Sichuan Clover Biopharmaceuticals, Inc (China) (“Clover”) through a global pivotal Phase 2/3 efficacy clinical trial and to licensure in China and globally, if the vaccine is proven to be safe and effective.
CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 million, including previously announced commitments of $69.5 million which have funded preclinical studies and Phase 1 clinical trials, preparations for the global pivotal Phase 2/3 efficacy study, and initial manufacturing scale-up activities. Promising preclinical and preliminary Phase 1 data – which will be published in a peer-reviewed publication in the near future - indicate that S-Trimer is well-tolerated and produces strong neutralizing antibody and Th1-biased cell-mediated immune responses, which merit ongoing evaluation of the vaccine candidate.
The expanded partnership is a result of Clover’s successful early stage clinical development of the S-Trimer vaccine candidate. It will provide full funding for a global pivotal Phase 2/3 efficacy clinical trial of S-Trimer which is expected to begin before the end of 2020 and aims to generate the necessary safety and efficacy data to support licensure of the vaccine candidate. It will also fund additional clinical studies in special populations, such as people with autoimmune conditions, immunocompromised individuals, pregnant women and children. In parallel to the clinical development process, the programme will continue scaling up the manufacturing process to potentially allow the production of more than one billion doses annually, and build up vaccine inventory which – if the vaccine is proven to be safe and effective - could be deployed rapidly upon licensure.
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. CEPI and Clover are committed to ensuring equitable global access to the S-Trimer vaccine, and the agreement therefore anticipates that vaccine output funded by CEPI’s investment – potentially hundreds of millions of doses per year – will be made available for procurement and allocation through the COVAX Facility. The COVAX Facility is a global initiative which aims to procure and fairly distribute two billion doses of COVID-19 vaccine by the end of 2021, to help protect the most at-risk groups in all participating countries.
Dr. Richard Hatchett, CEO of CEPI said:
“The clinical development and manufacturing progress of Clover’s S-Trimer vaccine candidate are very promising so far, so I am pleased to extend our partnership with Clover through to potential licensure of the vaccine.”
“CEPI’s expanded investment will fund critical late-stage clinical trials to establish the efficacy of the vaccine, in parallel to scaling up the manufacturing process with the goal of making potentially hundreds of millions of doses of this vaccine available to those who need it through COVAX, if it is proven to be safe and effective.”
Joshua Liang, CEO of Clover said:“We are honoured to receive CEPI’s continued investment which is based on months of close collaboration and early preclinical, manufacturing scale-up, and clinical success in the development of a safe and efficacious vaccine for COVID-19. This expanded partnership enables Clover to advance our S-Trimer vaccine candidate into a global Phase 2/3 efficacy study by the end of this year and subsequently to Chinese and global licensure in 2021. We look forward to continuing our partnership with CEPI as we stay committed to developing a safe and efficacious vaccine for communities in need around the globe.”
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’s COVID-19 vaccine programme
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 currently in the CEPI portfolio – the world’s largest - eight have entered clinical trials out of 44 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 will 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.
CEPI, alongside Gavi and the World Health Organisation, co-leads the vaccines pillar of the ACT Accelerator – known as COVAX – which is working to accelerate research and development for promising vaccine candidates, manufacture doses at scale, and ensure rapid global access.
CEPI opened a Representative Office in Shanghai in April 2020. 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.
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About CEPI
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 USD $350million 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.
About Trimer-Tag© Technology
Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.
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) – 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.
About the ACT-Accelerator
The Access to COVID-19 Tools ACT-Accelerator is a groundbreaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. The ACT-Accelerator brings together governments, scientists, businesses, civil society, and philanthropists and global health organizations (the Bill & Melinda Gates Foundation, CEPI, FIND, Gavi, The Global Fund, Unitaid, Wellcome, the WHO, and the World Bank). These organizations have joined forces to speed up an end to the pandemic by supporting the development and equitable distribution of the tests, treatments and vaccines the world needs to reduce mortality and severe disease, restoring full societal and economic activity globally in the near term, and facilitating high-level control of COVID-19 disease in the medium term.
The ACT-Accelerator comprises four pillars: diagnostics, therapeutics, vaccines (COVAX) and health system strengthening.