VBIV VBI Vaccines Inc.

3.58
-0.18  -5%
Previous Close 3.76
Open 3.79
52 Week Low 0.4655
52 Week High 6.93
Market Cap $827,690,258
Shares 230,648,396
Float 170,663,289
Enterprise Value $783,233,968
Volume 25,451,738
Av. Daily Volume 15,648,453
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
VBI-1901 and GM-CSF or AS01
Recurrent glioblastoma multiforme (rGBM)
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
BRII-179 (VBI-2601)
Hepatitis B vaccine
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Sci-B-Vac - CONSTANT
Hepatitis B vaccine
Phase 3
Phase 3
Phase 3 data met primary endpoint - January 9, 2020. Data to be presented at EASL August 29, 2020.
VBI-2900
COVID-19 vaccine
Phase 1
Phase 1
Clinical trials to commence by the end of 2020.
VBI-1501
Congenital Cytomegalovirus (CMV)
Phase 1
Phase 1
Phase 2 trial planned.
Sci-B-Vac - PROTECT
Hepatitis B vaccine
Phase 3
Phase 3
Phase 3 data met co-primary endpoints but missed key secondary endpoint.

Latest News

  1. VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction…

    VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires were evaluated.

    "We continue to broaden the analysis around tumor responders in our ongoing Phase 1/2a study of VBI-1901 to enable us to identify GBM patients most likely to benefit from the vaccine immunotherapeutic in the next phase of clinical development," said Dr. David E. Anderson, VBI's Chief Scientific Officer. "This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. As with the previously announced CD4+/CD8+ ratio, a biomarker which may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients, these biomarkers will continue to be evaluated throughout the study."

    In parallel to the ongoing biomarker analysis, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK's AS01B adjuvant system continues, with initial immunologic and tumor data expected in Q4 2020.

    The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

    About the Phase 1/2a Study Design

    VBI's two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

    • Phase 1 (Part A)
      • Dose escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
      • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
      • Enrollment completed in December 2018.
    • Phase 2a (Part B)
      • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
      • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK's proprietary AS01B adjuvant system as immunomodulatory adjuvants.
      • Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.

    VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

    About VBI-1901 and GBM

    VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ((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.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on 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 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. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry 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 establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, 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 such 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 duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    View Full Article Hide Full Article
  2. VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that its abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, the company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients was selected for an e-poster presentation at The European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    Presentation Details

    Title: TCR and HLA analysis of patients in a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)

    Abstract #: 4112

    Date/Time: Thursday, September 17, 2020 – Monday, September 21, 2020

    About the Phase

    VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that its abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, the company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients was selected for an e-poster presentation at The European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    Presentation Details

    Title: TCR and HLA analysis of patients in a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)

    Abstract #: 4112

    Date/Time: Thursday, September 17, 2020 – Monday, September 21, 2020

    About the Phase 1/2a Study Design

    VBI's two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

    • Phase 1 (Part A)
      • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
      • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
      • Enrollment completed in December 2018.
    • Phase 2a (Part B)
      • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
      • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK's proprietary AS01B adjuvant system as immunomodulatory adjuvants.
      • Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.

    VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

    About VBI-1901 and GBM

    VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ((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.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on 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 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. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry 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 establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, 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 such 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 duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    View Full Article Hide Full Article
  3. 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

    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.

    Poster Presentation

    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. ((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.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on 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 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. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry 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 establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, 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 such 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 duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    View Full Article Hide Full Article
  4.  - VBI-2901 and VBI-2902 selected as trivalent and monovalent coronavirus vaccine candidates, respectively, for an adaptive Phase 1/2 clinical study expected to begin around year-end 2020, subject to regulatory approvals

    - After one dose, compared to high-titer convalescent sera, preclinical data demonstrated 10x higher antibody binding geometric mean titer (GMT) and 4x higher neutralizing antibody GMT, with neutralizing antibody GMT increasing to 64x after a second dose

    - GMP clinical manufacturing expected to begin in September 2020 at Therapure Biomanufacturing – potential to leverage capacity to support large-scale manufacturing

    - VBI to host conference call and webcast today, Wednesday, August 26 at 8:30 a.m. ET

    VBI Vaccines Inc…

     - VBI-2901 and VBI-2902 selected as trivalent and monovalent coronavirus vaccine candidates, respectively, for an adaptive Phase 1/2 clinical study expected to begin around year-end 2020, subject to regulatory approvals

    - After one dose, compared to high-titer convalescent sera, preclinical data demonstrated 10x higher antibody binding geometric mean titer (GMT) and 4x higher neutralizing antibody GMT, with neutralizing antibody GMT increasing to 64x after a second dose

    - GMP clinical manufacturing expected to begin in September 2020 at Therapure Biomanufacturing – potential to leverage capacity to support large-scale manufacturing

    - VBI to host conference call and webcast today, Wednesday, August 26 at 8:30 a.m. ET

    VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced data from three preclinical mouse studies conducted to enable selection of optimized clinical candidates for the company's coronavirus program, VBI-2900. As a result of these studies, VBI has selected two vaccine candidates, with the potential to be one-dose vaccines, to take into an adaptive Phase 1/2 human clinical study, expected to begin around year-end 2020, subject to regulatory approval: (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 (COVID-19) spike protein.

    The objectives of the preclinical studies, which evaluated antibody binding titers and neutralizing antibody titers across a number of vaccine constructs, were to assess the impact of VBI's proprietary enveloped virus-like particle (eVLP) platform technology vs. recombinant vaccine candidates, differences in the conformation of the spike protein, and a variety of adjuvants. The data demonstrated:

    • Neutralizing Antibody (nAb) Activity: After a single dose, VBI's eVLPs expressing a stabilized pre-fusion form of the COVID-19 spike protein elicited a nAb GMT that was 4x higher than the GMT of high-titer convalescent sera, which increased to 64x higher after a second dose
    • Antibody Binding (Ab) Activity: The same eVLPs also induced, after one dose, an Ab binding GMT that was 10x higher than both the GMT of high-titer convalescent sera and the GMT induced with a stabilized pre-fusion recombinant spike protein
    • Impact of Adjuvants: A variety of adjuvants tested further improved the induction of nAb titers approximately 5-fold, and promoted strong Th1-type antibody and T cell responses
    • Additional Benefit of Trivalent Construct: The trivalent eVLP vaccine construct induced Ab binding titers across COVID-19, SARS, and MERS spike proteins in addition to broadening reactivity to a seasonal human coronavirus not expressed in the vaccine

    "We are excited to announce these impressive pre-clinical data, which we believe clearly support the advancement of the two vaccine candidates, VBI-2901 and VBI-2902, into human clinical studies around the end of the year," said Jeff Baxter, VBI's President and CEO. "An effective solution to the ongoing COVID-19 pandemic will require a vaccine that is capable of providing robust protection, quickly. Based on the data seen to-date, we believe the VBI-2900 program has the potential to be administered as a one-dose vaccine regimen at human doses ranging from 2-5mcg, and, further, VBI-2901 may offer increased breadth of reactivity across a broader range of coronaviruses. We are very encouraged by these results and remain deeply committed to addressing this devastating public health crisis."

    As part of these studies, convalescent sera from 20 individuals who had contracted and recovered from COVID-19 were collected for comparison – this sera was further grouped according to those who mounted a high-titer, robust response to the infection and those with a low-titer, weaker response. The neutralizing activity in these studies were quanitifed using a plaque reduction neutralization test with the most stringent 90% inhibition threshold (PRNT90), which is considered the gold standard for measuring antibodies that can neutralize a virus.

    In August, VBI also entered into an agreement with Therapure Biomanufacturing, an integrated Contract Development and Manufacturing Organization (CDMO), for development and manufacturing services in preparation for production of its coronavirus vaccine candidates. The collaboration with Therapure is expected to enable the initiation of clinical studies by the end of 2020. As part of the agreement, Therapure will manufacture bulk vaccine for use through Phase 2 clinical studies.

    Conference Call and Webcast Details

    VBI Vaccines will host a conference call and webcast with accompanying slides on Wednesday, August 26, 2020 at 8:30 AM ET. The live webcast and slide presentation can be accessed via the Events/Presentations page in the Investors section of the company's website, or by clicking this link: https://lifescipartners.zoom.us/webinar/register/.

    A replay of the webcast will be archived on the company's website for 30 days following the live conference call.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ((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.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on 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 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. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry 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 establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, 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 such 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 duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    View Full Article Hide Full Article
  5. VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company's tri-antigenic prophylactic hepatitis B (HBV) vaccine, have been accepted for presentation at The Digital International Liver CongressTM 2020 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), taking place on August 27-29, 2020. The presentations will include a late-breaker oral presentation and a poster presentation, which has been selected for a poster tour.

    The presentation details and schedules are as follows:

    Late-Breaker Oral

    VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company's tri-antigenic prophylactic hepatitis B (HBV) vaccine, have been accepted for presentation at The Digital International Liver CongressTM 2020 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), taking place on August 27-29, 2020. The presentations will include a late-breaker oral presentation and a poster presentation, which has been selected for a poster tour.

    The presentation details and schedules are as follows:

    Late-Breaker Oral Presentation

    • Abstract #: AS169
    • 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)
    • Session: Abstract Session: HBV – Clinical
    • Date: Saturday, August 29, 2020
    • Time: 12:15 – 12:30 CEST
    • Presenter: 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
    • Event Website: https://ilc-congress.eu/

    The oral presentation will be displayed as a 10-minute pre-recorded video followed by a five-minute live Q&A session.

    Poster Presentation

    • Abstract #: 1181
    • 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)
    • Session: Poster tour: Viral Hepatitis A, B, C, D, E: Immunology
    • Date: Thursday, August 27, 2020
    • Time: 12:30 – 13:00 CEST
    • Presenter: Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Northern Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies
    • Event Website: https://ilc-congress.eu/

    Dr. Vesikari will give a live presentation of the poster during the Poster Tour, followed by a three-minute live Q&A session. A five-minute pre-recorded explanation of the poster will also be available on-demand at the Event Website link above.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ((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.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on 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 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. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry 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 establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, 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 such 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 duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    View Full Article Hide Full Article
View All VBI Vaccines Inc. News