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