Positive Omicron data from the COVID-19 Phase II trial reported for the ABNCoV2 vaccine

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Hørsholm, Denmark, May 5, 2022 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces that additional positive results for the ABNCoV2 vaccine, that is being developed as a universal booster vaccine, has been reported from the Phase II clinical trial conducted by Bavarian Nordic. The new study data demonstrates a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects with a fold increase in the same range as previously reported for the original Wuhan SARS-CoV2 variant. Bavarian Nordic continues to plan for rapid initiation of a Phase III study

Bavarian Nordic announces that data from subjects, who were previously vaccinated with approved mRNA or adenoviral vaccines, demonstrated that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects with a fold increase in the same range as previously reported for the original Wuhan SARS-CoV2 variant. While the neutralizing antibody titers against Omicron were the lowest when compared to all other variants previously reported (Wuhan, Alpha, Beta and Delta) they were boosted to levels associated with a high level of protection across both dose groups, 50μg and 100μg.

These data follow the announcement of topline results from the Phase 2 trial in December 2021 and February 2022, demonstrating that a single vaccination with 50μg or 100μg ABNCoV2 can boost neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV21[1], irrespective of type of vaccine previously received (mRNA or adenovirus-based), or the initial level of neutralizing antibody titers before booster vaccination with ABNCoV2.

CEO Bent Frandsen comments:        

“The Bavarian Nordic-sponsored Phase II clinical trial has now also shown a strong and broad immune response induced by ABNCoV2 against the COVID-19 Omicron variant. We remain excited by Bavarian Nordic’s progression towards the Phase III study and their subsequent submission of this vaccine for licensure.”

Additional information can be found in the press release published today by Bavarian Nordic, see link https://www.bavarian-nordic.com/investor/news/news.aspx?news=6559.

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 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. These strong positive results were further confirmed when the remaining data from the COUGH-1 study was announced in November 2021.

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[1] P. B. Gilbert et al., Science 10.1126/science.abm3425 (2021)

For further information about ExpreS2ion Biotech Holding AB, please contact:

Bent U. Frandsen, CEO
Telephone: +45 4256 6869

Keith Alexander, CFO
Telephone: +45 5131 8147

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.