Hørsholm,
As reported previously by ExpreS2ion, the data from the first study group of 103 subjects demonstrated that a single booster dose with the ABNCoV2 vaccine raised the neutralizing antibodies against the original (
The additional results reported today from a group of 66 seropositive subjects who received one lower dose (50 μg) of ABNCoV2 confirm similar high neutralizing antibody levels against the same SARS-CoV-2 variants of concern as observed with the higher dose. Taking the pre-booster levels and/or time since the last vaccination into account, the higher booster dose of ABNCoV2 trended towards inducing stronger levels of neutralizing levels against SARS-CoV-2. Furthermore, a group of 28 seronegative subjects, who had not been previously vaccinated or infected with SARS-CoV-2, received 2 doses of the 100 μg formulation of ABNCoV2 4 weeks apart. The neutralizing antibody levels against the
The vaccine was generally well-tolerated, with no related serious adverse events reported and no relevant difference in the safety profile between subjects receiving either the low (50 μg) or high dose (100 μg) of ABNCoV2. While the 50 μg dose has shown positive results, it has been decided to use the 100 μg dose in the Phase III trial to maximize the likelihood of success.
The Phase III trial is planned to be initiated in the first half of 2022. It will include approximately 4,000 seropositive study participants who will receive a booster vaccination with 100 μg ABNCoV2 or an mRNA-based vaccine, aiming to demonstrate non-inferiority of ABNCoV2 to the licensed mRNA vaccine. An overall agreement has been made with regulatory authorities on the trial design, and manufacturing of vaccine bulk for the trial has been completed, pending filling at
CEO
"It is encouraging to see that the full Phase II data confirms the strong and broad immune response induced by ABNCoV2 against COVID-19, and that
Additional information can be found in the press release published today by
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.
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
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For further information about ExpreS2ion
Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@expres2ionbio.com
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E-mail: ka@expres2ionbio.com
About ExpreS2ion
ExpreS2ion
https://news.cision.com/expres2ion-biotechnologies/r/additional-positive-phase-ii-covid-19-results-presented-for-the-abncov2-vaccine,c3515330
https://mb.cision.com/Main/14402/3515330/1541828.pdf
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