Durable antibody response reported for the ABNCoV2 COVID-19 vaccine six months after vaccination in the Phase II clinical trial
Hørsholm, Denmark, October 17, 2022 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces that follow-up results from Bavarian Nordic’s Phase II clinical trial for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 booster vaccine show that antibody titers remained high at levels associated with greater than 90% efficacy six months after vaccination for both the Wuhan and the Omicron variant.
Previously reported results from the trial showed that vaccination with 100ug ABNCoV2 in 103 seropositive subjects was able to demonstrate a strong boosting effect, increasing the existing levels of SARS-CoV-2 neutralizing antibodies against the Wuhan variant and variants of concern (Alpha, Beta, Delta and Omicron) to levels reported to be highly efficacious (>90%) against SARS-CoV-2.
For the follow-up analysis, 41 subjects were followed for six months post vaccination. From this group, two subjects with confirmed COVID-19 disease were excluded from the immune analysis. 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. This represented less than a 50% decline in the peak neutralizing titers after six months and 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.
CEO Bent Frandsen comments:
“These exciting follow-up results from the Phase II clinical trial confirm that the ABNCoV2 delivers a strong booster result also six months after vaccination for all variants of concern, including Omicron, without modification to the vaccine. This is great news that supports the use of ABNCoV2 as a universal booster vaccine. We look forward to seeing the results from the ongoing clinical Phase III trial, with sites opening up in Denmark shortly to include subjects in the Danish part of the trial.”
Bavarian Nordic expects the initial Phase III data readout towards end-2022, which will allow for a rolling submission to the regulatory authorities to obtain approval of the vaccine in 2023.
Additional information on the follow-up result from the Phase II clinical trial can be found in the press release published today by Bavarian Nordic, see link
https://www.bavarian-nordic.com/investor/news/news.aspx?news=6650
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.
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Telefon: +46 11 32 30 732
E-post: ca@skmg.se
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.
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