VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the presentation of two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company’s tri-antigenic prophylactic hepatitis B (HBV) vaccine, in a late-breaker oral presentation and a poster presentation at The Digital International Liver CongressTM 2020 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on August 27-29, 2020.
Late-Breaker Oral Presentation
Title: High HBsAb titers consistent across 3 lots of the tri-antigenic HepB Vaccine, Sci-B-Vac®: Results from the second pivotal Phase 3 double-blind, randomized controlled trial designed to assess the lot-to-lot consistency of Sci-B-Vac® in adults (CONSTANT)
During the presentation, Adam Finn, M.D., Ph.D., Professor of Paediatrics at the University of Bristol, UK, and principal investigator of the CONSTANT Phase 3 clinical study, discussed the successfully-met primary endpoint of CONSTANT – demonstration of consistency of immune response as measured by the geometric mean concentration (GMC) of hepatitis B antibodies (anti-HBs titers) across three consecutively-manufactured lots of vaccine. Additional data highlighted included:
High anti-HBs titers: GMC of anti-HBs for Sci-B-Vac was more than 7.5x compared to Engerix-B after 2 vaccinations (day 168) and more than 3x after 3 vaccinations (day 196)
Rapid Onset of Seroprotection: After 2 vaccinations, Sci-B-Vac elicited a 90.4% seroprotection rate (SPR) compared to 51.6% with Engerix-B, increasing to 99.3% vs. 94.8% after the 3rd dose
Safety: No new or unexpected safety signals seen with either study vaccine
"Currently-licensed hepatitis B vaccines, while effective, are not optimal. There is a need to improve their immunogenicity, reliability, and protection rates. Looking back at the data from the CONSTANT study, it’s clear that the immunogenicity of the tri-antigenic vaccine, Sci-B-Vac®, is significantly higher than that of the mono-antigenic vaccine, Engerix-B®," said Dr. Finn. "More than 90% of individuals vaccinated with Sci-B-Vac® in the CONSTANT study achieved seroprotection after the 2nd dose compared to roughly 50% with the currently licensed vaccine, Engerix-B®."
A recording of the presentation and copy of the slides are available on the "Events/Presentations" page in the "Investors" section of VBI’s website.
Title: Higher proportion of responders with Hepatitis B Antibody levels ≥ 100 mIU/mL with the tri-antigenic HepB vaccine, Sci-B-Vac®, compared to Engerix-B®: Results from the phase 3 double-blind, randomized study comparing immunogenicity and safety (PROTECT)
Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies, delivered the poster presentation. During the discussions, Dr. Vesikari highlighted Sci-B-Vac®’s ability to induce a more immunogenic response, defined as anti-HBs titers ≥ 100 mIU/mL, across a greater proportion of subjects compared to Engerix-B® in the PROTECT study. The data included:
Sci-B-Vac induced anti-HBs titers ≥ 100 mIU/mL in more subjects compared to Engerix-B (80.8% vs. 60.7%), with sustained improvement across demographic subgroups including age, BMI, diabetic status, smoking status, and gender.
Sci-B-Vac elicited 6x higher anti-HBs titers in all subjects compared to Engerix-B (1148.3 mIU/mL vs. 192.6 mIU/mL), again with sustained improvement across age, BMI, diabetic status, smoking status, and gender subgroups.
"The PROTECT study included an analysis of the more stringent anti-HBs titer threshold of 100 mIU/mL – in addition to the standard 10 mIU/mL threshold typically considered the correlate of seroprotection – to examine serological responses across the whole study population as well as various sub-populations," said Dr. Vesikari. "In the elderly and those with co-morbidities, such as diabetes and obesity, the conventional, licensed hepatitis B vaccine, Energix-B®, induced inadequate immune responses. The responses to the tri-antigenic vaccine, Sci-B-Vac®, were more robust as measured both by seroconversion rate and by anti-HBs titers. This data implies that Sci-B-Vac may be an improved alternative for adult vaccination against Hepatitis B."
A copy of the e-poster is available on the "Events/Presentations" page in the "Investors" section of VBI’s website.
About VBI Vaccines Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only tri-antigenic hepatitis B vaccine, Sci-B-Vac®, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic pan-coronavirus vaccine candidate. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.
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