VBI Vaccines Announces New Long-Term Follow-up Clinical Data for Its 3-Antigen Adult Hepatitis B Vaccine Showcased at EASL 2022


– Title of the presentation: “Long-term persistence of anti-HBs antibodies after vaccination with a 3 antigen HBV vaccine compared to a single antigen HBV vaccine”

CAMBRIDGE, Mass., June 28, 2022–(BUSINESS WIRE)–VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), an immunology-focused biopharmaceutical company pursuing potent disease prevention and treatment, today announced that new data from a follow-up analysis of a subset of participants in the company’s pivotal Phase 3 (PROTECT) study of the company’s 3-antigen hepatitis B (HBV) prophylactic vaccine, have been presented during an oral presentation at the International Liver Congress™ 2022 (ILC), the annual meeting of the European Union Association for the Study of the Liver (EASL), which took place on June 26, 2022.

Timo Vesikari, MD, 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 of VBI’s 3-antigen HBV vaccine, highlighted data from its investigator analysis which assessed the duration of the immune response approximately 2.5 years after the end of vaccination. Immunogenicity was assessed using frozen serum samples from a subset of participants (n=465) who had been recruited from five clinical sites in Finland as part of PROTECT. In the follow-up analysis, PROTECT participants who received VBI’s 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1,382.9 mIU/mL vs. 251, 4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI’s 3-antigen HBV vaccine maintained anti-HBs titers ≥100 mIU/mL, compared to 32.6% of those who received Engerix-B.

“In the PROTECT study, more adults were protected with VBI’s 3-antigen vaccine than with the single-antigen vaccine, and in this follow-up analysis, we continued to see benefits from the 3-antigen vaccine. “, said Francisco Diaz-Mitoma. , MD, Ph.D., Chief Medical Officer of VBI. “As we focus on the path forward and our commitment to expanding access to this vaccine in Europe and North America, we continue to believe that our 3-antigen vaccine has the potential to be a novel intervention. significant in the public health battle to eradicate hepatitis B.”

Detailed results of the follow-up study:

  • Higher SPRs observed in participants who received VBI’s 3-antigen HBV vaccine (3A-HBV) compared to Engerix-B (1A-HBV) in all key subgroups after 2.5 years of follow-up

    • Adults 18 years and older: 88.1% 3A-HBV versus 72.4% 1A-HBV [difference: 15.7%]

    • Adults 18-44: 96.2% 3A-HBV versus 81.3% 1A-HBV [difference: 14.9%]

    • Adults 45-64: 90.3% 3A-HBV versus 75.0% 1A-HBV [difference: 15.3%]

    • Adults ≥ 65 years: 81.8% 3A-HBV versus 65.2% 1A-HBV [difference: 16.6%]

    • Obese people (BMI > 30): 86.3% 3A-HBV versus 69.6% 1A-HBV [difference: 16.7%]

  • A higher percentage of participants who received 3A-HBV retained anti-HBs titers above 100 mIU/mL (72.9% vs 32.6% – difference: 40.3%)

  • Increased anti-HBs titers observed in participants who received 3A-HBV compared to 1A-HBV

    • In the PROTECT study, peak antibody titers (Day 196) were 2.1x higher in participants who received 3A-HBV compared to those who received 1A-HBV [8021.9 mIU/mL vs. 3787.3 mIU/mL]

    • In the 2.5-year follow-up study, mean peak antibody titers were 5.5 times higher in participants who received 3A-HBV compared to those who received 1A-HBV [1382.9 mIU/mL vs. 251.4 mIU/mL]

A copy of the oral presentation is available on the “Events/Presentations” page of the “Investors” section of the VBI website.

About tracking analysis:

The PROTECT follow-up analysis was investigator-initiated and conducted at five clinical sites in Finland, following 465 participants who received all three doses of study vaccines – either VBI’s 3-antigen HBV vaccine , the comparator vaccine, Engerix-B®. To perform immunogenicity testing, frozen serum samples were sent to the same central laboratory for evaluation using the same validated quantitative anti-HBs assay used in the PROTECT study. The objectives were to determine the durability of the immune response as measured by serum levels of HBV surface antibodies (anti-HBs titers) 2.5 years after the end of vaccination in the PROTECT study. Additional objectives were to determine the proportion of participants who maintained anti-HBs titers ≥ 10 mIU/mL and anti-HBs titers ≥ 100 mIU/mL 2.5 years after completion of vaccination.

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected worldwide. HBV infection is the leading cause of liver disease and with current treatments it is very difficult to cure, with many patients subsequently developing liver cancer. An estimated 900,000 people die each year from complications of chronic HBV such as hepatic decompensation, cirrhosis and hepatocellular carcinoma.

About VBI’s 3-Antigen HBV Vaccine

VBI’s Hepatitis B Vaccine is the only 3-antigen hepatitis B vaccine, consisting of the three surface antigens of the hepatitis B virus – S, pre-S1 and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom and Israel. The brand names of this vaccine are: PreHevbrio™ (US), PreHevbri™ (EU/EEA/UK) and Sci-B-Vac® (Israel).

Please visit www.PreHevbrio.com for important US safety information regarding PreHevbrio™ [Hepatitis B Vaccine (Recombinant)]or please see complete prescribing information in the United States.

The full European Summary of Product Characteristics for PreHevbri is available on the EMA website at www.ema.europa.eu and on the UK MHRA website at products.mhra.gov. uk.

American indication

PreHevbrio is indicated for the prevention of infections caused by all known subtypes of the hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

Important US Safety Information (ISI)

Do not give PreHevbrio to people who have had a history of severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or any component of PreHevbrio.

Appropriate medical treatment and supervision should be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised people, including those on immunosuppressive therapy, may have a decreased immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in people who have unrecognized hepatitis B infection when the vaccine is given.

The most common adverse reactions (>10%) in adults 18-44 years old, adults 45-64 years old, and adults 65 years and older were pain and tenderness at the injection site, myalgia, fatigue and headaches.

There is a Pregnancy Exposure Registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women receiving PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see complete prescribing information.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is an immunology-focused biopharmaceutical company in the pursuit of potent disease prevention and treatment. Through its innovative Virus-Like Particle (“VLP”) approach, including proprietary enveloped VLP platform (“eVLP”) technology, VBI is developing candidate vaccines that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and defeating important infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers, including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

For more information, visit www.vbivaccines.com.

Caution regarding forward-looking information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian law. securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. These forward-looking statements are based on management’s beliefs as well as assumptions made by management and information currently available to it. Actual results could differ materially from those contemplated by the forward-looking statements due to certain factors, including, but not limited to, the impact of general economic, industrial or political conditions in the United States or internationally. ; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are effective or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of candidate pipelines and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to commercialize potential products; the ability to obtain future financing for development products and working capital and to obtain such financing on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaboration with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to obtain and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties relating to the Company, is set forth in the Company’s filings with the SEC and Canadian securities regulators, including its Annual Report on Form 10. -K filed with the SEC on March 7, 2022, and filed with Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10- Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on these forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no obligation or duty to update or revise any forward-looking statements for any reason, except as required by law.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220628005346/en/


Contact VBI
Nicole Anderson
Director, Corporate Communications and IR
Telephone: (617) 830-3031 ext. 124
Email: IR@vbivaccines.com


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