ExpreS2ion provides update on ABNCoV2 Phase III clinical trial
Hørsholm, Denmark, February 15, 2023– ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") today provides an update on Bavarian Nordic’s Phase III clinical trial for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 booster vaccine. Today Bavarian Nordic announced that the top-line results are now anticipated around mid-2023 due to longer than expected recruitment times.
Bavarian Nordic announced today that the top-line data from its Phase III clinical trial of the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 booster vaccine will be delayed due to longer than anticipated patient recruitment times. The recruitment of subjects ≥65 years of age is taking longer than anticipated, pushing the expected completion of enrollment into the second quarter of 2023 with top-line results now anticipated around mid-2023.
CEO Bent Frandsen comments:
“Running a Phase III clinical trial is a complicated process with many variables affecting the timeline and outcome. The velocity of subject recruitment is one such variable and in this case it has been slower than expected by Bavarian Nordic, and thus resulted in a change in the estimated timeline. Looking forward, we remain hopeful that the data from the clinical trials will demonstrate an advantageous profile for ABNCoV2 relative to other vaccines on the market.”
About the cVLP COVID-19 vaccine product, ABNCoV2
Under the PREVENT-NCoV consortium, ExpreS2ion and its 34%-owned associate company AdaptVac have applied their unique Drosophila S2 insect cell protein production technology, ExpreS2™, 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. In the Phase II trial, ABNCoV2 was demonstrated to induce a significant boost to the neutralizing antibodies against all tested variants, including the Omicron variant. Furthermore, six months post vaccination, neutralization titers were six times higher than pre-boost titers against Wuhan and nearly 10 times higher than the pre-boost titers for Omicron BA.1. Compared to the data published for mRNA vaccines, the antibody decay appears less sharp, indicating a potentially longer duration of protection across variants of concern.
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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 Biotech Holding AB, 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 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel VLP based vaccines in association with AdaptVac ApS, of which ExpreS2ion owns 34%. For additional information, please visit www.expres2ionbio.com.