ExpreS2ion Biotechnologies: Positive topline results reported for the Phase II COVID-19 clinical trial with the ABNCoV2 vaccine
Hørsholm, Denmark, December 5, 2021 - ExpreS2ion Biotech Holding AB's affiliate ExpreS2ion Biotechnologies ApS ("ExpreS2ion") announces that the ABNCoV2 vaccine demonstrated a strong boosting effect in the clinical Phase II trial conducted by Bavarian Nordic. The existing levels of SARS-CoV-2 neutralizing antibodies increased by 2-40-fold, depending on the initial levels of antibodies, with no serious adverse events reported. Furthermore, this strong increase was observed to be similar for all variants tested (Wuhan, Alpha, Beta and Delta). The topline results confirm the vaccine's excellent profile as a non-adjuvanted universal COVID-19 booster vaccine.
The topline results reported today by Bavarian Nordic are based on the first of three groups in the trial, including 103 subjects (of 210 in total in the trial) 18 years and older (23% above 65 years) that had been previously vaccinated with mRNA (67%) or adenoviral (32%) COVID-19 vaccines. All subjects received a single booster dose with the ABNCoV2 vaccine. One week post vaccination, a 2-34-fold increase in the levels of neutralizing antibodies were observed against the original (Wuhan) variant and peaked at two weeks with a 2-40-fold increase depending on the initial antibody levels. However, all subjects, irrespective of whether they initially had very low, or high neutralizing titers were boosted to absolute antibody levels reported to be associated with a very high efficacy (>90%) against SARS-CoV2.
The same trend in terms of the fold-increases post the booster with ABNCoV2 were also observed for all other SARS-CoV2 variants tested, namely Alpha, Beta and Delta.
ABNCoV2 was well tolerated with no serious adverse events reported. The most frequent observations were local injection site reactions that resolved shortly after vaccination.
CEO Bent Frandsen comments:
"These excellent topline results from the Bavarian Nordic-sponsored on-going clinical Phase II trial confirm that the ABNCoV2 vaccine is able to boost COVID-19 immunity to levels associated with a high efficacy regardless of the antibody levels prior to the booster dose, and that is very encouraging. It is evident that there is a strong global need for an improved vaccine providing a more robust and long-lived level of protection, and ABNCoV2 has so far proven to have just the right profile to meet this demand."
Results from the two other study groups in the Phase II trial are expected during the first quarter of 2022. In parallel, Bavarian Nordic is also preparing for a Phase III trial of ABNCoV2, expected to be initiated in the first half of 2022 pending final feedback from the regulatory authorities.
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=6440.
About the cVLP COVID-19 vaccine product, ABNCoV2
Under the PREVENT-NCoV consortium, ExpreS[2]ion and its joint venture 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 (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. 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.
About AdaptVac
AdaptVac (http://www.AdaptVac.com.) is a joint venture between ExpreS[2]ion Biotechnologies (34% ownership) and NextGen Vaccines (66%), owned by the inventors of the novel proprietary and ground-breaking capsid virus-like particle (cVLP) platform technology spun out from the University of Copenhagen. AdaptVac aims to accelerate the development of highly efficient therapeutic and prophylactic vaccines within high value segments of oncology, infectious diseases and immunological disorders. Granting of the core patent in the U.S. has expanded AdaptVac's patent protection to include the full pipeline of vaccines and immunotherapies in development.
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This press release constitutes inside information that ExpreS2ion Biotech Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was sent for publication, through the agency of the contact persons set out above, at the time stated by the Company's news distributor, Cision, at the publication of this press release.