The ABNCoV2 COVID-19 vaccine program receives up to DKK 800 million from the Danish Ministry of Health
Hørsholm, Denmark, August 23, 2021 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces that Bavarian Nordic, the exclusive licensee of the ABNCoV2 COVID-19 vaccine, will receive up to DKK 800 million in funding from the Danish Ministry of Health for a Phase III trial to confirm safety and demonstrate efficacy as a booster vaccine, the experimental development of the necessary production processes, and the works related to the required regulatory authorisations.
This important milestone means that Bavarian Nordic now has a strong financial position when it comes to completing the ongoing clinical program for ABNCoV2, which is currently being evaluated in a Phase II trial, and the following market registration process.
Under the agreement, Bavarian Nordic is entitled to an upfront payment of DKK 80 million, in addition to payments of up to DKK 720 million, which are contingent upon reaching a number of predefined milestones including among others completion of the ongoing Phase II trial, Phase III development milestones and milestones related to upscaling of manufacturing for commercial production of the vaccine. The agreement is subject to final approval by the Finance Committee of the Danish Parliament.
All payments are potentially subject to repayment, however only upon successful marketing authorization of the vaccine by the European Commission. The Danish Ministry of Health could be entitled to an additional, capped royalty payment if the sales reach a certain threshold above the sales volume for the ordinary royalty payment.
CEO Bent Frandsen comments:
“This important funding from the Danish government constitutes a strong further validation of the ABNCoV2 COVID-19 vaccine program, including its importance for the global efforts to fight the COVID-19 pandemic. As a biotechnology company operating in Denmark, we are proud to see that the Danish government is now significantly stepping up its efforts to provide support for this project that involves many talented scientists from the Nordic region and Europe as a whole. For ExpreS2ion, this project once again highlights how our ExpreS2 platform is being used in world-class vaccine projects.”
More information can be found in the press release published today by Bavarian Nordic.
About the cVLP COVID-19 vaccine product, ABNCoV2
Under the PREVENT-NCoV consortium, ExpreS2ion and its joint venture AdaptVac have applied their unique Drosophila S2 insect cell protein production technology and capsid virus-like particle (VLP) COVID-19 technology, respectively, to develop a novel next-generation COVID-19 vaccine, known as ABNCoV2. Bavarian Nordic has licensed the global commercialization rights to the ABNCoV2 COVID-19 vaccine and variants hereof.
ABNCoV2 has shown to be highly immunogenic in relevant preclinical models inducing durable and highly protective response from a COVID-19 challenge. Initial Phase I/II clinical study data from COUGH-1, the first-in-human trial of the vaccine, have confirmed its ability to induce strong and broad antibody levels, superior to those of the current approved vaccines, while also providing a favorable safety profile. More importantly, the data confirms the potential of ABNCoV2 to induce neutralizing antibodies against circulating variants of SARS-CoV2, including the Delta variant.
Bavarian Nordic is sponsor of the Phase II trial, which is being conducted at two centers in Germany. The trial will enroll a total of up to 210 healthy adult volunteers into two groups: one group of 150 seropositive (prior disease or vaccinated) subjects will receive one 100 μg dose of ABNCoV2. Enrollment into this group will be stratified by seropositivity, i.e., previous COVID-19 disease or type of previous vaccination received, with at least 40 subjects enrolled in each stratification group. A second group of up to 60 seronegative subjects will receive two 100 μg doses of ABNCoV2, 28 days apart. The primary endpoint of the study is SARS-CoV-2 neutralizing antibody titers at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in seropositive subjects. Additional endpoints will, among others, focus on the safety of the vaccine and neutralizing antibody titers against variant strains circulating at the time of analysis at 2 weeks after last vaccination.
About AdaptVac
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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This press release constitutes inside information that ExpreS2ion Biotech Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was sent for publication, through the agency of the contact persons set out below, at the time stated by the Company’s news distributor, Cision, at the publication of this press release.
For further information about ExpreS2ion, please contact:
Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@expres2ionbio.com
Keith Alexander, CFO
Telephone: +45 5131 8147
E-mail: ka@expres2ionbio.com
About ExpreS2ion
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. ExpreS2ion develops novel capsid VLP based vaccines through its 34% owned joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com.