OSLO, Norway, SHANGHAI and KUNMING, China; 8 February 2022: CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will expand its collaboration with Shanghai Zerun Biotechnology Co., Ltd. (Zerun Bio) and its parent company Walvax Biotechnology Co., Ltd. (Walvax), a public company listed on the Shenzhen Stock Exchange (300142.SZ) to advance the development of a COVID-19 variant vaccine. CEPI will invest up to an additional USD$8.15 million to support a Phase I/II clinical trial in Mali which will evaluate the safety and immunogenicity of Zerun Bio’s prototype and multi-variant vaccine candidates. This will be the first clinical trial of the multi-variant vaccine, which has the potential to provide protection against a broad range of COVID-19 variants.
Including this latest funding, CEPI has now committed up to USD$25.1 million to this vaccine development partnership to support preclinical studies, early-stage clinical trials, process optimization and manufacturing scale-up of prototype and multi-variant vaccines. Results from a Phase I/II study of the prototype vaccine candidate, funded by CEPI, demonstrate that the product has a good safety profile and promising immunogenicity data. The data indicate that the prototype vaccine candidate induced a high level of immune response in adult subjects after two doses of vaccination, and the clinical serum demonstrated a good cross-neutralization effect on Beta and Delta strains. Preclinical studies showed that the multi-variant vaccine developed through the same technology platform also demonstrated a broad spectrum of cross-neutralization results for multiple Variants of Concern, including Alpha, Beta, Gamma, Delta, and Omicron, as well as for the prototype strain. The data from these studies will be submitted for publication in a peer reviewed journal shortly.
Enabling equitable access
CEPI, Zerun Bio and Walvax are committed to enabling global equitable access to this COVID-19 vaccine. Under the terms of the agreement, it is anticipated that vaccine output funded by CEPI’s investment will be procured and allocated through the COVAX Facility, which aims to deliver equitable access to COVID-19 vaccines for all participating countries, at all levels of development.
Zerun Bio’s commercialization plant for COVID-19 vaccines in Daxing District, Beijing, China, is expected to be put into use in 2022, enabling Zerun Bio to produce commercial volumes of COVID-19 vaccine.
Dr Richard Hatchett, CEO of CEPI said:
“I am pleased to expand CEPI’s partnership with Zerun Bio and Walvax, based on the promising early data for this vaccine candidate. COVID-19 continues to evolve, and we cannot predict which path it will take next, so it’s vital that we continue to invest in globally accessible vaccines that are effective against a broad range of possible variants. Such vaccines can put us a step ahead of the virus, so they are central to the long-term control of COVID-19, and vital to global health security.”
Mr. Yunchun Li, Chairman of the Walvax Board said:
“I am thrilled that we and our subsidiary Zerun Bio have expanded the collaboration with CEPI in our shared goal of introducing new vaccine solutions to help fight the COVID-19 pandemic. I reaffirm that Walvax will continue to mobilize all internal resources to support and accelerate this project and fulfil our commitment of providing a safe, effective and affordable vaccine to help battle COVI-19 in the longer term.”
Mr. Jiankang Zhang, Vice President of Walvax, CEO & President of Zerun Bio said:
“We are very grateful to CEPI and its donors for the new funding to support a Phase I/II clinical trial in Mali which will evaluate the safety and immunogenicity of our prototype and multi-variant vaccine candidates. Our team is highly motivated by the new grant and will keep the momentum to work more closely with CEPI with a sense of urgency to achieve the goal of developing globally accessible vaccines that provide broad protection against COVID-19 variants.”
This press release is also available in Chinese.
About the Recombinant SARS-CoV-2 Variant Vaccine (CHO cell) (CpG 7909/Alum adjuvant)
Zerun Bio’s Recombinant SARS-CoV-2 Variant Vaccine (CHO cell) applied the S protein trimer technology platform to develop an S trimer antigen protein with a stable pre-fusion conformation. Zerun Bio’s COVID-19 vaccine is composed of the S trimer antigen combined with dual adjuvants, namely CpG 7909 and aluminium hydroxide adjuvant. Preclinical studies have shown that the vaccine can induce strong, broad spectrum, and durable neutralizing antibody and cell-mediated immune responses.
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 http://www.endpandemics.cepi.net.
About Zerun Bio
Zerun Bio is an innovative biopharmaceutical company focusing on the research, development, and manufacturing of new recombinant human vaccines. The company was founded in 2003 and is located in Zhanjiang Hi-Tech Park, Pudong New District, Shanghai. Zerun Bio is one subsidiary of Walvax Biotechnology Co., Ltd., a company listed on Shenzhen Stock Exchange.
For more information, please visit the website: http://www.ZerunBio.com/
Founded in 2001, Walvax Biotechnology Co., Ltd. (Walvax) is a leading vaccine producer, engaged in research and development, manufacturing and distribution of safe and efficacious quality vaccines. Headquartered in China’s southwestern city Kunming in Yunnan Province, Walvax went to IPO in 2010 (300142.SZ) and started business expansion from traditional vaccines to innovative vaccines. With the vision of dedicating to be the pride domestically and the pioneer globally in the vaccine industry, producing efficacious, quality, innovative and affordable products to protect people from the world’s deadliest diseases, Walvax’s purpose is to help everyone live a healthy life.
For more information, please visit the website: http://www.walvax.com/ .
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Ms. Qiaoying Shen
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Mr. Andrew Wong, MD
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