COVID-19 Phase II clinical trial initiated to evaluate ABNCoV2 as a booster vaccine
Hørsholm, Denmark, August 23, 2021 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") announces that a Phase II clinical trial to evaluate the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine has been initiated by Bavarian Nordic. The trial will investigate the potential of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination. Initial trial results are expected in the second half of 2021.
The trial will enroll 150 healthy adults with existing immunity against SARS-CoV-2, acquired through previous disease or from prior immunization with approved COVID-19 vaccines, and will investigate the ability of a single vaccination with ABNCoV2 to boost existing levels of SARS-CoV-2 neutralizing antibodies across all groups. A second arm in the trial will enroll up to 60 healthy adults with no prior vaccination or disease who will receive two vaccinations for evaluation of neutralizing antibody levels from ABNCoV2 when used as a prime-boost vaccine. In both groups, neutralizing immune responses against circulating variants of SARS-CoV2 will be evaluated.
In parallel with the Phase II trial, Bavarian Nordic is preparing for a regulatory Phase III trial of ABNCoV2 in 2022, pending external funding.
CEO Bent Frandsen comments:
“I am excited that the ABNCoV2 vaccine is now being advanced into this Phase II clinical trial. The recently announced encouraging preclinical results indicate that this vaccine candidate induces remarkably strong antibody levels, which makes it very well suited to be used as a general booster vaccine, and as a vaccine to broaden the protection against emerging variants.”
A press release from Bavarian Nordic on the Phase II trial can be found in this NASDAQ-link.
About ABNCoV2 and the Phase II trial
Under the PREVENT-NCoV consortium, ExpreS2ion 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 to the ABNCoV2 COVID-19 vaccine and variants hereof.
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.
Bavarian Nordic is sponsor of the Phase II trial, which is being conducted at two centers in Germany. The trial will enroll a total of up to 210 healthy adult volunteers into two groups: one group of 150 seropositive (prior disease or vaccinated) subjects will receive one 100 μg dose of ABNCoV2. Enrollment into this group will be stratified by seropositivity, i.e., previous COVID-19 disease or type of previous vaccination received, with at least 40 subjects enrolled in each stratification group. A second group of up to 60 seronegative subjects will receive two 100 μg doses of ABNCoV2, 28 days apart. The primary endpoint of the study is SARS-CoV-2 neutralizing antibody titers at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects and after the single boost vaccination in seropositive subjects. Additional endpoints will, among others, focus on the safety of the vaccine and neutralizing antibody titers against variant strains circulating at the time of analysis at 2 weeks after last vaccination.
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
Telefon: +46 11 32 30 732
E-post: ca@skmg.se
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.
For further information about ExpreS2ion Biotech Holding AB, please contact:
Bent U. Frandsen, CEO
Telephone: +45 4256 6869
E-mail: buf@expres2ionbio.com
About ExpreS2ion
ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion has developed a unique technology platform, ExpreS2, for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS2 is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 300 proteins and 40 virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel capsid VLP based vaccines through its 34-% owned joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com.
Tags: