Approval and initiation of the COVID-19 clinical phase I/II study for the ABNCoV2 vaccine
Hørsholm, Denmark, March 8, 2021 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces that the clinical trial application (CTA) for a clinical phase I/II study for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine has been approved by the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands. The clinical study is now starting with the enrolment of up to 42 study participants to investigate safety and secondary efficacy parameters. First human dosing is planned for March 12, 2021. The CTA approval is in line with the plans to present initial clinical Phase I/IIa results in Q1 2021.
This CTA approval marks another significant milestone for ExpreS2ion, its joint venture partner AdaptVac, their development collaborators in the PREVENT-nCoV consortium and Bavarian Nordic in the EU Horizon 2020-funded COVID-19 vaccine project. Radboud University Medical Center in the Netherlands is responsible for the clinical trials, and the recruitment of study participants has already begun, and the first human dosing is planned for March 12, 2021. The trial is designed to assess the power of the cVLP technology in combination with ExpreS2-made SARS-CoV2 antigens to safely induce a strong immune response.
Furthermore, today Bavarian Nordic announced preclinical data in a non-human primate (NHP) study for ABNCoV2, which confirm the previous strong immunogenicity results already published, and further demonstrate a protective efficacy from vaccination post-challenge with SARS-CoV-2.
CEO Bent Frandsen comments:
“It is with great acknowledgment of my outstanding fellow colleagues at ExpreS2ion Biotechnologies, as well as our collaboration partners at AdaptVac and all of the additional PREVENT-nCoV consortium members, that I now announce the CTA approval and the initiation of the first clinical trial for the ABNCoV2 COVID-19 vaccine. We remain on track to present initial clinical phase I/IIa results in Q1 2021.”
Bavarian Nordic continues to seek further financing and partners
Bavarian Nordic is responsible for the further clinical development, manufacturing and commercialization of the ABNCoV2 COVID-19 vaccine. These plans are dependent on external funding, which Bavarian Nordic is in the process of seeking from various initiatives established to rapidly advance COVID-19 vaccines. The recently presented promising pre-clinical non-human primate data adds further credibility to the vaccine from a regulatory and market perspective.
About the cVLP COVID-19 vaccine product, ABNCoV2
ExpreS2ion and its joint venture partner AdaptVac are engaged in the development of a unique capsid virus-like particle (VLP) COVID-19 vaccine, partly sponsored through a Horizon 2020 EU grant award to the PREVENT-nCoV consortium to rapidly advance the vaccine candidate against COVID-19 into the clinic. This vaccine technology has the potential to mimic a virus to the body’s immune system, giving the optimal stimulus to generate a fast, long-lasting immune response that offers a highly-efficacious protection. Importantly, the production of the vaccine technology can be readily scaled to commercial quantities and ExpreS2ion and AdaptVac are working with AGC Biologics for the manufacture and scale-up of the vaccine. Bavarian Nordic has licensed the commercialization rights to the ABNCoV2 cVLP COVID-19 vaccine and variants hereof.
About the clinical phase I/II study for the ABNCoV2 vaccine (COUGH-1)
The clinical phase I/II study, also known as COUGH-1, has as main trial objectives to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio following first vaccination with ABNCoV2. COUGH-1 is a phase 1, single centre, open labelled trial in healthy, adult, SARS-CoV-2-naïve volunteers. The trial involves first-in-human administration, pre-defined, sequential dose escalation of ABNCoV2, and adjuvant selection. It intends to inform dosage and formulation for subsequent clinical development.
About the PREVENT-nCoV consortium
The consortium is funded by an EU Horizon 2020 grant to develop a COVID-19 vaccine. Further the vaccine development at University of Copenhagen is supported by the Carlsberg Foundation, the research councils and Gudbjørg og Ejnar Honorés Fond. The consortium members are world-leading experts in their respective fields, covering all relevant areas of viral research and vaccine development required for rapid clinical development of a COVID-19 vaccine. This includes pre-clinical and clinically validated experience from working with similar Coronaviruses such as MERS and SARS, ExpreS2ion’s Drosophila S2 insect cell expression system (ExpreS2), and AdaptVac’s capsid virus-like particle (cVLP) technology. In addition to ExpreS2ion and AdaptVac, the consortium members are Leiden University Medical Center (LUMC), Institute for Tropical Medicine (ITM) at University of Tübingen), the Radboud university medical center (RUMC), the Department of Immunology and Microbiology (ISIM) at University of Copenhagen, and the Laboratory of Virology at Wageningen University.
AdaptVac is a joint venture between ExpreS2ion Biotechnologies (34% ownership) and NextGen Vaccines (66%), owned by the inventors of the novel proprietary and ground-breaking capsid virus-like particle (cVLP) platform technology spun out from the University of Copenhagen. AdaptVac aims to accelerate the development of highly efficient therapeutic and prophylactic vaccines within high value segments of oncology, infectious diseases and immunological disorders. Granting of the core patent in the U.S. has expanded AdaptVac’s patent protection to include the full pipeline of vaccines and immunotherapies in development.
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For further information about ExpreS2ion Biotech Holding AB, please contact:
Bent U. Frandsen, CEO
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ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion has developed a unique technology platform, ExpreS2, for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS2 is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies. Since 2017, ExpreS2ion develops novel capsid VLP based vaccines through its joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com and www.adaptvac.com.