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Analyst Comment

ExpreS2ion Biotechnologies: Phase 3 Covid-19 topline results meets primary objective

By Michael FriisHead of Equities
ExpreS2ion Biotech Holding

The partner, Bavarian Nordic, has released its phase 3 topline results for the COVID-19 booster vaccine candidate. The booster study successfully met its primary objective.

The booster study successfully met its primary objective by showing that ABNCoV2 was non-inferior to Comirnaty® in terms of neutralizing antibodies against the SARS-CoV-2.

The announcement also states that the primary objective likely is insufficient to support a product approval on its own, due to the continued mutations of SARS-CoV-2 resulting in more distant variants, than the original strain.

Read the full announcement here: https://view.news.eu.nasdaq.com/view?id=b360cc78831f8dd816c21ab0759cf57df&lang=da&src=listed

Further data that looks at the secondary objectives, comparing ABNCoV2 to Comirnaty in terms of neutralizing antibodies against circulating variants will now be crucial to understand the current effectiveness and determining the potential and regulatory pathway.

These results are anticipated in the third quarter of 2023 as part of the second part of the study (safety and tolerability).

In an earlier announcement, ExpreS2ion Biotechnologies opened for the possibility that there might be a need for a seasonal adjustment, which the ExpreS2™ platform can handle.

On the positive side, outside the Covid-19, the strong antibody and protection against a non-mutating virus bodes well for our other pipeline asset and signal for the ExpreS2™ antigen and cVLP combination platform, as the platform now has been successful in a large-scale phase 3 study.  

HC Andersen Capital receives payment from ExpreS2ion Biotechnologies for a Digital IR/Corporate Visibility subscription agreement. /Michael Friis, 27 June 2023, 17:00.

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ExpreS2ion is a Danish-based biotech company listed in Sweden. The company develops a portfolio of vaccines for diseases such as COVID-19, influenza, and breast cancer through the use of its non-viral cell-based expression system, ExpreS2, which is recognized for handling protein challenges. ExpreS2ion has developed Expres2, which is a technology platform for efficient and fast non-clinical development and production of complex proteins for new vaccines and diagnostics. The company’s current primary product is the corona vaccine candidate, ABNCoV2 in phase 2, co-developed with its partner, AdaptVac of which ExpreS2ion owns 34%. The vaccine candidate has been licensed to Bavarian Nordic has global commercialization rights and responsibility for further clinical development of the vaccine and is expected to initiate phase 3 testing for the product candidate in the first half of 2022.

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