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 (https://news.cision.com/expres2ion-biotechnologies/r/expres2ion-s-joint-venture-adaptvac-signs-final-license-agreement-with-bavarian-nordic-on-covid-19-v,c3157573) to the ABNCoV2 COVID-19 vaccine and variants hereof.

ABNCoV2 has shown to be highly immunogenic in relevant preclinical models (https://news.cision.com/expres2ion-biotechnologies/r/strong-preclinical-immunization-data-for-the-abncov2-cvlp-based-covid-19-vaccine-published-in-nature,c3266812) inducing durable and highly protective response from a COVID-19 challenge. Initial Phase I/II clinical study data from COUGH-1 (https://news.cision.com/expres2ion-biotechnologies/r/positive-safety-and-efficacy-outcome-of-the-covid-19-clinical-phase-i-ii-study-for-the-abncov2-vacci,c3393447), 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 (https://news.cision.com/expres2ion-biotechnologies/r/positive-omicron-data-from-the-covid-19-phase-ii-trial-reported-for-the-abncov2-vaccine,c3561051). 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 (https://news.cision.com/expres2ion-biotechnologies/r/durable-antibody-response-reported-for-the-abncov2-covid-19-vaccine-six-months-after-vaccination-in-,c3649260).

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