VBI Vaccines Inc (VBIV)

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$VBIV or IBIO

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VBI Vaccines Announces Multiple Presentations at the Canadian Liver Meeting 2021
May 03 2021 - 08:00AM
Business Wire
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that two abstracts highlighting data from the pivotal Phase 3 program evaluating the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine candidate have been accepted for oral and poster presentation at the Canadian Liver Meeting 2021, taking place virtually May 2-5.

Presentation details and schedules are as follows:

Oral Presentation

Abstract #: 007
Abstract Title: Higher Seroprotection Rates (SPR) And Higher Anti-HBs Concentrations In Adults Age 18+ Achieved With 3-Antigen Hepatitis B Vaccine (3A-HBV) Compared To 1-Antigen Hepatitis B Vaccine (1A-Hbv): Results From the Pivotal, Double-Blind, Randomized Phase 3 Study (Protect)
Presenter: Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer
Session: Panel 2
Date: Tuesday, May 4, 2021
Time: 2:00-2:10 PM ET

The oral presentation will include a 10-minute pre-recorded presentation followed by five minutes of live Q&A.

Poster Presentation

Abstract #: P071
Abstract Title: Higher Seroprotection Rates (SPR) And Higher Anti-HBs Concentrations In Adults Age 18-45 Immunized With 3-Antigen Hepatitis B Vaccine (3A-HBV) Compared To 1-Antigen Hepatitis B Vaccine (1A-HBV): Results From the Pivotal, Double-Blind, Randomized Phase 3 Study (CONSTANT)
Poster Availability: e-Poster will be on display in the Canadian Liver Meeting 2021 Poster Gallery

Copies of both presentations will be available on the “Events/Presentations” page in the “Investors” section of VBI’s website.

About Hepatitis B

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

About VBI’s 3-Antigen Hepatitis B Vaccine

VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

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

News and Resources: http://www.vbivaccines.com/news-and-resources/

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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210503005207/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[cheynew]

VBI Vaccines Announces Publication of Preclinical & Challenge Study Data of its eVLP Vaccine Candidate Against COVID-19 (VBI-...
April 28 2021 - 08:00AM
Business Wire
- Publication title: “An enveloped virus-like particle vaccine expressing a stabilized prefusion form of the SARS-CoV-2 spike protein elicits potent immunity after a single dose”

- Publication to be available on pre-print server, bioRxiv, and has been submitted for scientific journal peer-review

- Initial data from ongoing Phase 1/2 clinical study of VBI-2902 expected by the end of Q2 2021

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that preclinical data of VBI’s enveloped virus-like particle (eVLP) vaccine candidate, VBI-2902, has been submitted for peer-review to a scientific journal and will be available on the online preprint server, bioRxiv. These data demonstrate that VBI’s eVLP vaccine candidate expressing a modified, prefusion form of the SARS-CoV-2 spike protein elicited a highly potent and focused neutralizing antibody response, and conferred protective benefit in Syrian golden hamsters challenged with COVID-19, assessed in terms of clinical disease (loss of body weight) and lung inflammation.

VBI evaluated enveloped virus-like particles (eVLPs) expressing various forms of the SARS-CoV-2 spike protein to identify a COVID-19 vaccine candidate with the potential to be highly efficacious after a single dose. VBI developed a modified prefusion (optimized) form of the SARS-CoV-2 spike protein, VBI-2902, that resulted in strong and durable neutralizing antibody responses compared to the native form of the SARS-CoV-2 spike protein.

Notable results described in the publication, include:

Hamster challenge study:

SARS-CoV-2 infection in Syrian golden hamsters resemble features found in humans with moderate COVID-19 infection and is characterized by rapid weight loss
Animals in all groups lost 2-4% of body weight 2 days post-infection (2dpi)
Animals in the saline control group continued to lose weight until an average of 15% loss at 7dpi, before gradually gaining weight
In contrast, none of the hamsters immunized with two doses of VBI-2902 lost any further weight after 2dpi, regaining normal weight by 7dpi, demonstrating robust protection against COVID-19
In the single dose regimen, the majority of animals regained body weight after 3dpi instead of 2dpi, suggesting slightly delayed but still significant protection against COVID-19
Additionally, at 3dpi, hamsters vaccinated with either one or two doses of VBI-2902 had greatly decreased viral RNA copy numbers in lungs and reduced lung inflammation
Neutralizing antibody (nAb) response in mice:

A single injection of VBI-2902 induced nAb responses with PRNT90 end-point titers of 160, more than 3x higher than nAb responses induced with human convalescent sera in the control pool (PRNT90 end-point titers of 50)
All nAb responses were greatly enhanced by the second injection
Peak nAb levels were sustained and remained undiminished for at least 15 weeks
PRNT90 is the most stringent 90% inhibition threshold plaque reduction neutralization test
Antibody and T cell response in mice:

A Th2-type response has been suggested to contribute to the “cytokine storm” associated with vaccine-induced severe lung pathologies
Compared to a clear Th2-biased profile observed in response to recombinant SARS-CoV-2 spike proteins, when presented by eVLPs, the similar prefusion SARS-CoV-2 construct induced a balanced Th1/Th2 response
“We have previously demonstrated that expression of proteins on the surface of eVLPs dramatically enriches neutralizing activity, the presumed correlate of protection against SARS-CoV-2, relative to recombinant proteins, and these data are further confirmation of the potency of the eVLP platform and our optimized form of the SARS-CoV-2 spike protein,” said David E. Anderson, VBI’s Chief Scientific Officer. “VBI-2902 has the potential to offer substantial benefit in the prevention of COVID-19, including robust immunogenicity at fewer doses without the need for transportation in ultra-cold chains. Based on the strength of this preclinical data, we initiated a Phase 1/2 study in Canada in adults and look forward to sharing initial data by the end of the second quarter of 2021.”

This preclinical research was conducted through VBI’s Ottawa-based research facility in collaboration with the National Research Council of Canada (NRC), and was supported by the Government of Canada’s Innovation, Science and Economic Development (ISED) funding through the Strategic Innovation Fund (SIF).

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illnesses of varying severity, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).1,2

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

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

News and Resources: http://www.vbivaccines.com/news-and-resources/

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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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.

References

“Coronavirus.” World Health Organization, https://www.who.int/health-topics/coronavirus.
“Coronaviruses.” National Institute of Allergy and Infectious Diseases, https://www.niaid.nih.gov/diseases-conditions/coronaviruses




View source version on businesswire.com: https://www.businesswire.com/news/home/20210428005541/en/

VBI
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[cheynew]

VBI Vaccines to Participate in National Securities Corporation’s Biotech Investor Summit
April 27 2021 - 08:00AM
Business Wire
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will discuss VBI’s coronavirus vaccine candidates in a virtual, analyst-led biotech investor summit hosted by National Securities Corporation, Member FINRA/SIPC, on Wednesday, April 28 at 1:30 PM ET.

Presentation Details:

- Event: Over the Hump: Vaccine Strategies and Preparedness in a Variant World
- Presenters: Jeff Baxter, President and CEO, and David E. Anderson, Ph.D., Chief Scientific Officer
- Moderator: Cosme Ordonez, M.D., Ph.D., National Securities’ Senior Biotechnology Analyst
- Date: Wednesday, April 28, 2021
- Time: 1:30 PM ET
- Live Webcast: https://lp.constantcontactpages.com/cu/KVDkeLo

A replay of the summit will be available on the “Events/Presentations” page in the “Investors” section of VBI’s website.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210427005314/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[cheynew]

VBI VACCINES ANNOUNCES PRESENTATION AT THE 2021 ANNUAL CONFERENCE ON VACCINOLOGY RESEARCH

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced its abstract featuring data from PROTECT, a pivotal Phase 3 immunogenicity and safety study evaluating the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine candidate, has been accepted for oral presentation at the National Foundation for Infectious Diseases’ (NFID) 2021 Virtual Annual Conference on Vaccinology Research (ACVR), taking place April 26-27.

Presentation Title: Higher seroprotection rates (SPR) and anti-HBs titers achieved in adults with a 3-antigen hepatitis B vaccine (3A-HBV) compared to a 1-antigen hepatitis B vaccine (1A-HBV): Results of the PROTECT study
Session: Oral Abstract Q&A Breakout Sessions – Vaccine Research, Development, and Production
Date: Tuesday, April 27, 2021
Time: 3-4 PM ET

About Hepatitis B

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

About VBI’s 3-Antigen Hepatitis B Vaccine

VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac ® in Israel.

To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210426005226/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[cheynew]

Brii Biosciences, Vir Biotechnology, and VBI Vaccines Announce Initiation of Phase 2 Clinical Trial of
BRII-835 (VIR-2218) in Combination with BRII-179 (VBI-2601) for the Treatment of Hepatitis B

– New combination trial of an RNA-targeted therapeutic candidate and an HBV immunotherapeutic candidate aimed at delivering a functional cure for chronic hepatitis B infection –

DURHAM, N.C., BEIJING, CHINA, SAN FRANCISCO, Ca., CAMBRIDGE, Mass. April 21, 2021 – Brii Biosciences (Brii Bio), Vir Biotechnology, Inc. (Nasdaq: VIR), and VBI Vaccines Inc. (Nasdaq: VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI, and is the sponsor of the Phase 2 study (NCT04749368). It will be conducted at sites in Australia, China, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

Li Yan, M.D., Ph.D., chief medical officer of Brii Bio, said: “Sustained seroclearance of HBV surface antigen, also known as a functional cure, occurs rarely in the natural history of HBV infection or during the current standard of care treatment. We believe that both viral antigen knockdown with BRII-835 (VIR-2218) and sustained induction of HBV-specific host immune responses by BRII-179 (VBI-2601) are required to remove viral immunosuppression and subsequently break immune tolerance. The combination of these two agents is a step toward developing a functional cure for HBV.”

Phil Pang, M.D., Ph.D., chief medical officer of Vir, said: “This new combination trial represents an important addition to our HBV portfolio approach of combining VIR-2218 with various immunomodulators, including pegylated interferon alpha, VIR-3434 and with a TLR8 agonist, via our previously announced collaboration with Gilead. We look forward to determining if such combinations can stimulate an effective immune response that may result in a finite duration of treatment.”

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Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s chief medical officer, said: “We believe that a functional cure for HBV is possible, and will require restoration of HBV-specific immunologic control in addition to viral suppression mechanisms. Data from our previous study suggest BRII-179 (VBI-2601) was able to restimulate both antibody and T cell responses specific to HBV. This combination study represents the first combination of a therapeutic HBV vaccine to restore HBV-immunity with antivirals designed to reduce the levels of HBV surface antigens. We look forward to seeing the outcome of the trial, a milestone that will be meaningful in our collective efforts to provide an effective solution for patients with such a complex and highly infectious virus.”

About BRII-835 (VIR-2218)

BRII-835 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Brii Bio licensed exclusive rights to develop and commercialize VIR-2218 for the greater China territory from Vir in 2020.

In addition to the Phase 2 combination trial with BRII-179 (VBI-2601), VIR-2218 is being evaluated in two ongoing trials: as a monotherapy for HBV, and in combination with pegylated interferon-alpha (PEG-IFN-a). Two additional Phase 2 trials of VIR-2218 are expected to start in 2021.

About BRII-179 (VBI-2601)

VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate, and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences in the licensed territory of China, Hong Kong, Macau, and Taiwan as part of a potential functional cure for chronic hepatitis B infection.

About Brii Biosciences

Brii Biosciences (Brii Bio) is a multi-national company committed to serving patients’ needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People’s Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases. For more information, visit www.briibio.com.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

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About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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, please visit www.vbivaccines.com.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “potential,” “aim,” “could” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-2218, BRII-179, pegylated interferon-alpha, and VIR-3434 (individually or in combination), the expected timing of commencement of clinical trials and availability of clinical data, our goals with respect to the prophylaxis and/or treatment of HBV, the potential ability of our product candidates (individually or in combination with other agents) to functionally cure HBV and change the standard of care, the potential of ESC+ technology to enhance the therapeutic index of VIR-2218, and the potential benefits of Vir’s collaboration with Brii Biosciences and other partners. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, difficulties in obtaining regulatory approval, difficulties in collaborating with other companies, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

3


VBI 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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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.

Contact:

Lisa Beck
Brii Biosciences
[e-mail]

Cara Miller
VP, Corporate Communications
[e-mail]
[phone]

Nicole Anderson
Director, Corporate Communication & IR
[e-mail]
[phone] x124

[cheynew]

VBI VACCINES ANNOUNCES PHASE 1B/2A DATA AND PROGRESS OF HEPATITIS B IMMUNOTHERAPEUTIC CANDIDATE

Data from Phase 1b/2a study in chronic HBV patients show robust HBV specific T cell responses in ≥ 50% of evaluable patients across all study arms of VBI-2601 (BRII-179)
VBI-2601 (BRII-179) was well-tolerated with no safety signals observed at both low- and high-dose levels
Patient screening for the Phase 2 combination study of high-dose VBI-2601 (BRII-179) and BRII-835 (VIR-2218) initiated March 2021 – first patient first dose anticipated early Q2 2021
VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced data and next steps from the high-dose cohort of its Phase 1b/2a clinical study of VBI-2601 (BRII-179), the company’s hepatitis B immunotherapeutic candidate, in chronically-infected hepatitis B patients. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences (Brii Bio) as part of a potential functional cure for chronic hepatitis B virus (HBV) infection.

The Phase 1b/2a is a randomized, controlled study designed to assess the safety, tolerability, antiviral and immunologic activity of VBI-2601 (BRII-179) in 46 non-cirrhotic patients with chronic HBV infection on nucleos(t)ide analogue (NUC) therapy. The study is a two-part study to evaluate four doses of VBI-2601 (BRII-179), at either a low (20 µg) or high (40 µg) dose, with and without co-administration of interferon-alpha (IFN-a).

Data to-date from 33 evaluable patients across all study arms suggest:

VBI-2601 (BRII-179) was well-tolerated at all dose levels with and without IFN-a, with no significant adverse events identified
Restimulation of T cell immune responses to HBV surface antigens, including S, Pre-S1, and Pre-S2, in ≥ 50% (range: 50% - 78%) of evaluable patients from all VBI-2601 (BRII-179) cohorts – compared to no detectable response in the control, NUC-only arm
The T cell responses and antibody responses were comparable across the 20µg and 40µg unadjuvanted study arms
T cell response rates between the adjuvanted and unadjuvanted cohorts were also comparable
VBI and Brii are targeting the presentation of the complete Phase 1b/2a dataset at a scientific conference later in 2021.

Based on the acceptable safety profile and vaccine-induced adaptive immune responses observed to-date, the high dose of VBI-2601 (BRII-179), both with and without IFN-a, was selected to progress into a Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), a novel small interfering ribonucleic acid (siRNA) therapeutic candidate designed to inhibit expression of HBV proteins. Patient screening for the study initiated in March 2021 in New Zealand, and Brii Bio expects to initiate the study in China, Hong Kong, Australia, Taiwan, Singapore, Thailand, and South Korea in the second and third quarter of 2021.

About Hepatitis B

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

About VBI-2601 (BRII-179)

VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate, and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences in the licensed territory of China, Hong Kong, Macau, and Taiwan as part of a potential functional cure for chronic hepatitis B infection.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210412005138/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]
News Provided by Business Wire via QuoteMedia

[Nealio]

So they bought all their shares and ready to get on the train...lolz
I'm ready for 6+
Great stock, great products...just need shorts to be shown the exit!

[now invest]

Oppenheimer..... cme out with a buy today..... target $8!!

[Tincupx]

Would you like some cheese with that whine?

[Jaydixson1]

Vbiv rated STRONG Buy at E*TRADE

[InspectorX]

I’m convinced. This is my worst investment ever. I was dumb enough to buy in at $4.50 on a hot tip last year without checking. I have yet to see green on this.

[cheynew]

CEPI and VBI Vaccines Collaborate to Advance Vaccine Candidates Against COVID-19 Variants
March 10 2021 - 07:00AM
Business Wire
Up to $33m of funding will support development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against COVID-19 variants of concern.
Phase 1 clinical study of VBI’s eVLP vaccine candidate, VBI-2905, targeting the B.1.351 variant, anticipated to initiate mid-year 2021.
CEPI, the Coalition for Epidemic Preparedness Innovations, and VBI Vaccines Inc. (Nasdaq: VBIV), today announced a partnership to develop VBI’s enveloped virus like particle (eVLP) vaccine candidates against SARS-CoV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210310005316/en/

CEPI will provide up to $33m to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the B.1.351 strain, through Phase 1 clinical development. As part of the agreement, this funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of VBI’s eVLP technology. This preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants.

Dr Richard Hatchett, CEO of CEPI, said:

“Remarkable progress has been made to develop safe and effective vaccines against COVID-19, but in parallel to the global roll out of vaccines we must now redouble our R&D efforts so we have the tools we need to tackle emerging variants of the virus. I am delighted that CEPI will support the development of VBI’s promising vaccine candidates against variants of concern, which crucially can be made globally accessible through COVAX if proven to be safe and effective.

“Today, CEPI also launches its 5-year plan to substantially reduce, and in the long-term even eliminate, the risk of epidemic and pandemic diseases, including coronaviruses. If we are to achieve this future, we must act now by investing in crucial R&D to optimise our vaccination strategies and technologies.”

Jeff Baxter, President and CEO of VBI, said:

“We are grateful for CEPI’s partnership, support, and confidence in our eVLP approach to vaccine development. We look forward to working with CEPI, who has played a crucial role in the development of COVID-19 vaccines over the last 12 months, and we remain steadfast in our mission to contribute to the end of the ongoing pandemic and the long-term protection against coronaviruses.”

VBI’s eVLP technology has been supported by investment from the Government of Canada, which is a long-standing and vital CEPI supporter and investor.

Karina Gould, Canadian Minister of International Development, said:

“Canada is deeply committed to its vaccine partnerships. The innovative collaboration announced today will help to ensure that millions will have access to safe vaccines against COVID-19 and future infectious disease threats.”

Race against viral mutation

CEPI is investing in the development of vaccines against COVID-19 variants to help the world to stay one step ahead of the virus.

The virus that causes COVID-19 is constantly mutating. Variant B.1.1.7 (first identified in the UK) is up to 70% more transmissible than the virus that emerged in Wuhan and has since been confirmed to be associated with an increased risk of hospitalisation and death. Variants B.1.351 and P.1 (identified in South Africa and Brazil, respectively) are even more concerning. They spread rapidly, can reinfect people who have been infected before, and they are rendering our countermeasures—including our vaccines and monoclonal-antibody treatments—less effective. The increased transmissibility of these variants could result in a reversal in the global downward trends in transmission seen in recent weeks resulting in a renewed burden on health systems, and more deaths.

Equitable access key to ending acute phase of pandemic

The rate of viral mutation is a function of the global spread of the virus, so it is imperative to control transmission everywhere. CEPI is therefore committed to enabling global equitable access to COVID-19 vaccines and, through this agreement, CEPI and VBI have agreed that the vaccine candidates supported by CEPI will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate. To date, COVAX has delivered vaccines to over 30 countries, with the aim of distributing 2 billion doses globally in 2021.

VBI’s eVLP Coronavirus Vaccine Candidates

VBI Vaccines is advancing a suite of coronavirus vaccine candidates, under the VBI-2900 program, developed using the Company’s proprietary eVLP platform technology in collaboration with the National Research Council of Canada. Coronaviruses are enveloped by nature which make them a prime target for VBI’s eVLP platform technology. VBI’s eVLP technology is flexible and highly customizable, allowing for expression of multiple protein antigens of interest on the surface of the particles. eVLPs create a close mimic of the natural presentation of viruses and they carry multiple copies of the target protein, designed to trigger a potent immune response.

Through this partnership with CEPI, VBI will develop VBI-2905 through Phase 1, and additional multivalent candidates through preclinical studies. VBI and CEPI expect to initiate Phase 1 studies of VBI-2905 – the first eVLP-based vaccine candidate in the CEPI portfolio - mid-year 2021.

An adaptive Phase 1/2 study of VBI-2902 is already ongoing at nine clinical sites in Canada, having initiated earlier in March 2021, and is supported by a contribution from the Canadian Government’s Strategic Innovation Fund.

Notes to Editors

Preclinical Data from VBI’s eVLP Coronavirus Vaccine Candidates

Previous preclinical studies suggest the highly potent and immunogenic potential of the eVLP platform. In a series of preclinical studies of VBI-2902, a monovalent eVLP expressing the stabilized pre-fusion form of the SARS-CoV-2 spike protein, neutralizing antibody (nAb) geometric mean titers (GMT) elicited by the vaccine candidate registered 4x higher than the GMT of high-titer convalescent sera after one dose, increasing to 64x higher after two doses. Additionally, preclinical evaluation of VBI-2901, a trivalent eVLP candidate expressing the SARS-CoV-2, SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins, showed the vaccine induced antibody titers to all three coronaviruses expressed in the vaccine, in addition to a seasonal human coronavirus, HCoV-OC43. Broadened reactivity to HCoV-OC43, a coronavirus not expressed in the vaccine candidate, suggests that VBI’s multivalent eVLPs may allow for the production of broadly reactive antibodies, which offer potential for protection from known and emerging variants of COVID-19.

CEPI’s $3.5 billion investment case – The Urgency of Now. Turning the tide against epidemic and pandemic infectious diseases

The full investment case, published today, may be accessed at www.endpandemics.cepi.net.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 12 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

Follow our news page for the latest updates. Follow us on Twitter and LinkedIn.

About VBI Vaccines Inc

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/

About COVAX

COVAX is the vaccines pillar of the ACT-Accelerator. It is co-led by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization (WHO) with lead delivery partner UNICEF, working in partnership with developed and developing country vaccine manufacturers, the World Bank, Civil Society Organisations and others. COVAX is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to economies of all financial means.

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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210310005316/en/

CEPI
Email: [e-mail]
Phone: [phone]

VBI Vaccines Inc
Nicole Anderson
Director, Corporate Communications & IR
Email: [e-mail]
Phone: [phone] x124

[cheynew]

VBI VACCINES ANNOUNCES INITIATION OF ENROLLMENT IN ADAPTIVE PHASE 1/2 STUDY OF PROPHYLACTIC COVID-19 VACCINE CANDIDATE, VBI-2902

- Initial data from Phase 1 of the study expected by the end of Q2 2021, subject to rate of enrollment

- Adaptive Phase 1/2 study supported by previously announced contribution from Strategic Innovation Fund of Canadian Government of up to CAD$56 million

- Initiation of Phase 1/2 study of pan-coronavirus vaccine candidate, VBI-2901, anticipated later in 2021

VBI Vaccines Inc. (Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announce the initiation of enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate.

“We are excited to begin the clinical assessment of our eVLP approach to vaccination against coronaviruses with this first clinical study of VBI-2902,” said Jeff Baxter, President and CEO of VBI. “We are committed to bringing forward candidates that add meaningful clinical and medical benefit to those already approved – be it as a one-dose administration, more durable immune responses, and/or providing broader protection against known and emerging variants of COVID-19. We are grateful for the support of our Canadian partners at the Department of Innovation, Science and Economic Development, the National Research Council of Canada, and Resilience Biotechnologies. We look forward to sharing initial data from this study in the coming months.”

“Our Government is investing in a range of Made-in-Canada solutions to support our fight against COVID-19,” said François-Philippe Champagne, Canada’s Minister of Innovation, Science and Industry. “Today’s news is a welcome development, bringing VBI one step closer to delivering a safe and effective COVID-19 vaccine for Canadians. Through this investment, we continue to expand our toolbox to help fight this pandemic as well as future pandemics.”

Mitch Davis, President, National Research Council Canada, further commented, “The National Research Council of Canada and VBI Vaccines have a long-standing collaboration in research. Since March 2020, we have been working jointly with their research operations in Ottawa on activities for pre-clinical evaluation, optimization, and manufacturing process development of this COVID-19 vaccine candidate. We are very pleased to see this candidate reach the important milestone of human clinical trials.”

The adaptive Phase 1/2 clinical study is randomized, observer-blind, placebo-controlled, and will evaluate the safety, tolerability, and immunogenicity of VBI-2902, adjuvanted with aluminum phosphate. The Phase 1 portion of the study will evaluate a one- and two-dose regimen of a 5µg dose of VBI-2902, and is planned to enroll up to 60 healthy adults age 18-54. Contingent upon rate of enrollment, the initial data from Phase 1 of this study are expected by the end of Q2 2021. The Phase 2 portion of the study is expected to be a dose-escalation extension study, assessing one- and two-dose regimens, that will enroll an expanded adult population across three age cohorts: 18-54, 55-65, and 65+. The study will be conducted at nine clinical sites in Canada.

The execution of this adaptive Phase 1/2 study is supported by funding from the Strategic Innovation Fund of the Government of Canada. VBI’s coronavirus vaccine program is being developed at the Company’s research facilities in Ottawa, Canada, and with the National Research Council of Canada (NRC), a collaboration that was recently expanded to include additional joint research and development activities for pre-clinical evaluation, optimization of clinical candidates, and manufacturing scale-up.

About VBI’s Coronavirus Vaccine Program: VBI-2900

VBI-2900 consists of two enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, and (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the SARS-CoV-2 spike protein. The vaccine program was developed in collaboration with the National Research Council (NRC) beginning in early 2020, with promising preclinical data announced August 2020 enabling the selection of the two clinical candidates. Through their Strategic Innovation Fund, the Government of Canada has awarded VBI up to CAD$56 million to support clinical development through Phase 2 studies, to be paid as retrospective reimbursement for eligible expenses incurred.

The initial Phase 1/2 study of VBI-2902 initiated in March 2021. Work remains ongoing to further optimize and manufacture VBI-2901, with a Phase 1/2 study initiation anticipated later in 2021.

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illnesses of varying severity, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS). 1,2

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
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 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, 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.

“Coronavirus.” World Health Organization , https://www.who.int/health-topics/coronavirus .
“Coronaviruses.” National Institute of Allergy and Infectious Diseases, https://www.niaid.nih.gov/diseases-conditions/coronaviruses

View source version on businesswire.com: https://www.businesswire.com/news/home/20210309005592/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[avro5]

test

[mattw69]

VBI Vaccines Stock Could Blast Higher by 170%, Says Analyst
https://finance.yahoo.com/news/vbi-vaccines-stock-could-blast-234248070.html

[cheynew]

VBI Vaccines to Present at the Raymond James 42nd Annual Institutional Investors Conference
March 01 2021 - 08:00AM
Business Wire
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will participate in an analyst-led fireside chat at the Raymond James 42nd Annual Institutional Investors Conference on Tuesday, March 2, 2021, at 4:40 PM ET.

Presentation Details:

Event: Raymond James 42nd Annual Institutional Investors Conference
Presenters: Jeff Baxter, President and CEO, and David E. Anderson, Ph.D., Chief Scientific Officer
Date: Tuesday, March 2, 2021
Time: 4:40 – 5:20 PM ET
Webcast: https://kvgo.com/rjinstitutionalinvestors/vbi-vaccines-inc-march-2021
A recording of the webcast will be available on the “Events and Presentations” page of the Company’s website: https://www.vbivaccines.com/investors/events-and-presentations/.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant 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.

Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/

[cheynew]

Here’s a summary on VBIV I found on Twitter:

https://docs.google.com/document/d/1EheVd2DuTO4j4kLfbdLiHvEXYVC_MVbFvWpt6AHphus/edit

[cheynew]

$VBIV Initiated with a $7 PT from Jefferies.

[MyAlias1]

One thing that I don't understand is that the HBV vaccine is being compared to Engerix-B ... what about Dynavax's Heplisav-B?

[InspectorX]

I checked the chart. Holding... it should continue to rise. If we see it hit $3.65 we have a problem.

[InspectorX]

Also I already saw all the stuff about Raymond James saying the whole $9 thing and all that. Believe it or not $9 was my price target for this last year when I got it. Just like RESN price target I deemed was $7. It went to $7.50 and I sold it. This VBiV scam I assumed was gonna hit $9.

[InspectorX]

Keep it? Sell it? Hold it? Dump it? More than broke even so far... thinking I should’ve sold when it spiked last week and hit $4.15 or something. Somebody tell me something... should I hold it or should I sell it?? ANSWER ME!!!!!

[InspectorX]

I thought this was a terrible mistake. I got these shares for $4 a while ago. Just now they’re coming back. Bad move I made!!

[cheynew]

State Street added over 3 mil shares q/e 12/31.

https://ih.advfn.com/stock-market/NASDAQ/vbi-vaccines-VBIV/stock-news/84314698/statement-of-ownership-sc-13g

[stock1ace1]

Nice breakout today ~> https://stockcharts.com/h-sc/ui?s=vbiv

[stock1ace1]

Roughly 44 Million shares short !

[Tincupx]

Consensus target average I believe is around 5.50 I believe. I wouldn’t get caught up in the hopes that the Reddit fellas attack it. That seems unlikely. The float is only 20% short. It’s a good trade though regardless

[Rayn_Makr]

10 Short Squeeze Candidates Under $10 on Benzinga includes VBIV.

https://finance.yahoo.com/news/10-short-squeeze-candidates-under-200216594.html

Hard to control my imagination if the Robinhood crew goes after VBIV. It wouldn't take much to get over $10. I hope this is the beginning of the end of short selling but the hedge funds will fight to the end. Battle lines are being drawn.

[cheynew]

VBI Vaccines Announces U.S. FDA Acceptance of BLA Filing for VBI’s 3-Antigen Prophylactic Hepatitis B Vaccine
February 02 2021 - 08:00AM
Business Wire
Alert
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- FDA sets a target action date of November 30, 2021

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its filing of the Biologics License Application (BLA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021.

“The FDA acceptance of our BLA represents a significant milestone for VBI, but more importantly for the effort to provide broad access to this vaccine, which we believe has the potential to be a meaningful intervention for adults in the fight against hepatitis B,” said Jeff Baxter, President & CEO. “Progress in preventing HBV infection has stalled, and the 11 percent increase in U.S. acute cases from 2014 to 2018 highlights the need for renewed focus, innovation, and action in the space. We are committed to working with the FDA throughout their review process over the course of this year as we work to address this serious, but preventable, public health threat.”

Additionally, in the filing notification letter, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

The BLA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – in addition to other relevant data. The studies were designed to assess the efficacy and safety of VBI’s 3-antigen HBV vaccine compared with Engerix-B®, as well as the lot-to-lot manufacturing consistency of VBI’s vaccine.

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI’s 3-Antigen Hepatitis B Vaccine

VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

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 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel under the name Sci-B-Vac® and completed its Phase 3 program in the U.S., Europe, and Canada in 2020; 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 coronavirus vaccine program. 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; unanticipated delays in both the commencement and completion of our planned 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210202005180/en/

Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[ClayTrader]

* * $VBIV Video Chart 02-01-2021 * *

Link to Video - click here to watch the technical chart video

[mick]

[-chart]www.stockscores.com/chart.asp?TickerSymbol=vbiv&TimeRange=1825&Interval=w&Volume=1&ChartType=CandleStick&Stockscores=1&ChartWidth=1100&ChartHeight=480&LogScale=&Band=&avgType1=&movAvg1=&avgType2=&movAvg2=&Indicator1=None&Indicator2=None&Indicator3=None&Indicator4=None&endDate=&CompareWith=&entryPrice=&stopLossPrice=&candles=redgreen[/chart]

[now invest]

RAYMOND JAMES has a 9 dollar strong buy on it.... if it backs off I will look for a chance to add.....

[mick]

YES https://otcbb.swingtradebot.com/equities/VBIV

N.Y. , NASDAQ
https://swingtradebot.com/equities/VBIV

[now invest]

Nice trading thus far today!! Up over .20% thus far!!! I am loving It!!

[mick]

INTERESTING $VBIV

[BottomBounce]

$VBIV 3rd Resistance Point 3.84
2nd Resistance Point 3.68
1st Resistance Point 3.57
Last Price 3.08

[BottomBounce]

$VBIV The 4 analysts offering 12-month price forecasts for VBI Vaccines Inc have a median target of 7.00, with a high estimate of 9.00 and a low estimate of 3.00. The median estimate represents a +122.22% increase from the last price of 3.15.

https://money.cnn.com/quote/forecast/forecast.html?symb=vbiv

[BottomBounce]

$VBIV VBI Vaccines Announces Progress of Coronavirus Vaccine Program

https://finance.yahoo.com/news/vbi-vaccines-announces-progress-coronavirus-130000486.html

[BottomBounce]

$VBIV VBI Vaccines results from a Phase 4 study of its prophylactic 3-antigen hepatitis B virus vaccine in younger adults were published in Vaccine.

[kzivann]

Bid filled on morning dip after pre - rip.

VBIV

[cheynew]

VBI Vaccines Announces Progress of Coronavirus Vaccine Program
January 21 2021 - 08:00AM
Business Wire
Alert
Print
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Preclinical hamster challenge study demonstrated robust immunogenicity and efficacy compared to placebo
First Phase 1/2 study of VBI-2902 expected to begin in Q1 2021
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today provided an update on the progress of its coronavirus vaccine program, consisting of two vaccine candidates: (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 spike protein.

“Over the last several months, the preclinical results achieved with our two coronavirus vaccine candidates continue to excite us, and we are working hard to get these candidates into the clinic in forms that are optimized both for clinical outcome and long-term commercial viability,” said Jeff Baxter, VBI’s president and CEO. “The COVID-19 challenge we face as an industry is two-fold: first, how do we get the ongoing pandemic under control, and second, how do we ensure long-term protection against known and emerging coronaviruses. We continue to progress our candidates as we work to optimize, assess, and manufacture them, with the goal of bringing forward candidates that add meaningful clinical and medical benefit to those vaccines already approved – be it as a one-dose administration and/or providing broader protection against known and mutated future strains of COVID-19.”

Preclinical Hamster Challenge Study

The protective efficacy of VBI-2902, with two different adjuvant formulations, was assessed in hamsters where SARS-CoV-2 infection resembles features found in humans with moderate COVID-19 infection and is characterized by a rapid weight loss starting two days post infection. These challenge study data reaffirm the high antibody binding and neutralizing antibody titer data seen in previously announced preclinical studies. Additionally, VBI-2902, regardless of adjuvant formulation, was able to stop and reverse weight loss seen at two days post infection. Where VBI-2902 led to animals regaining normal weight seven days post-infection, the animals who received placebo lost an average of 15% body weight in that same timeframe. Additional observations in the vaccinated cohorts include prevention of peak viral replication in the lungs by approximately 10,000-fold and significantly reduced inflammation in the lungs compared to the placebo cohort.

These and other preclinical data are being targeted for publication.

Phase 1/2 Human Clinical Study

VBI expects to initiate the first Phase 1/2 clinical study of VBI-2902 in Canada in Q1 2021. The clinical study protocol has previously been positively reviewed by Health Canada. Though there have been unanticipated delays in receipt of release testing materials due to recent industry-wide supply chain issues, the Company has been working closely with its partners and Health Canada to complete testing and release of clinical materials to enable clinical study initiation. This study will use clinical material manufactured by our manufacturing partner, National Resilience, Inc., formerly Therapure Biomanufacturing.

Work is ongoing to further optimize and manufacture the Company’s pan-coronavirus vaccine candidate, VBI-2901, with the anticipation that a Phase 1/2 study will begin later in 2021.

To support the Phase 1/2 studies, VBI was awarded up to CAD$56 million by the Strategic Innovation Fund of the Government of Canada, to be paid as retrospective reimbursement for eligible expenses incurred.

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 3-antigen 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 coronavirus vaccine program. 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; unanticipated delays in both the commencement and completion of our planned 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210121005236/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[bleu22]

WOO HOO... Let’s gooo...

[cheynew]

VBI VACCINES ANNOUNCES PUBLICATION OF RESULTS FROM A PHASE 4 STUDY OF VBI'S PROPHYLACTIC 3-ANTIGEN HEPATITIS B VACCINE IN VACCINE

Publication of results from Phase 4 single-arm, open-label study in 91 healthy adults, age 20-40 years, to confirm reference standard for vaccine release to Israeli market
Seroprotection at month 3 (after 2 doses) was 98.8%, increasing to 100% at month 7 (after 3 doses)
GMC of anti-HBs titers was 413.6 mIU/mL and 6799.9 mIU/mL at month 3 and month 7, respectively
Consistent with the known safety profile of VBI’s vaccine, no safety signals were observed
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBI’s prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier. The study was designed to evaluate the immunogenicity of VBI’s 3-antigen HBV vaccine in support of the qualification of that batch as a new reference standard for vaccine release to the Israeli market, where VBI’s vaccine is available as Sci-B-Vac®.

“In this Phase 4 study, our 3-antigen HBV vaccine once again demonstrated robust immunogenicity with no additional safety signals observed,” said Dr. Francisco Diaz-Mitoma, VBI’s Chief Medical Officer. “The rapid onset of protection seen in this study may be particularly relevant to younger adults who need protection quickly, including healthcare workers and travelers. We believe our vaccine could be a meaningful intervention in the fight to eliminate hepatitis B and we look forward to working with the U.S. Food and Drug Administration and the European Medicines Agency in 2021 as part of the licensure process to expand access to this vaccine outside of Israel.”

Prior to market release in Israel, batches of VBI’s vaccine are tested against a reference vaccine batch that has been assessed in a clinical trial. According to the European Pharmacopeia, the reference batch should elicit, after the full course of vaccination, a seroprotection rate (SPR) of at least 95% in young and healthy adult participants. In this open-label, single-arm Phase 4 study in 91 healthy adults age 20-40 years, this objective was achieved two months after the second dose – the SPR at month 3 was 98.8% [95% CI: 93.7%, 99.7%]. SPR is defined as the percent of participants who achieve antibody titers (anti-HBs titers) above the protective threshold of 10 mIU/mL.

Additional results from this Phase 4 study include:

By month 7, after receiving three doses, all enrolled participants (100%) were seroprotected
The majority of participants were high responders, defined as achievement of anti-HBs titers ≥ 100 mIU/mL – high-responder SPR was 81.4% and 97.6% at month 3 (after 2 doses) and month 7 (after 3 doses), respectively
The geometric mean concentration (GMC) of anti-HBs titers were also substantially above the protective threshold at 413.6 mIU/mL and 6799.9 mIU/mL at month 3 and month 7, respectively
Anti-HBs titers were maintained above 2000 mIU/mL at month 12, suggesting a potent and sustained response
Consistent with other clinical data, VBI’s 3-antigen HBV vaccine was well-tolerated with no safety signals observed
Participants in this study were immunized with 10 µg of VBI’s HBV vaccine at months 0, 1, and 6.

The manuscript is available at: https://www.sciencedirect.com/science/article/pii/S0264410X20316303 .

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI’s 3-Antigen Hepatitis B Vaccine

This vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

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 3-antigen 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 coronavirus vaccine program. 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 source version on businesswire.com: https://www.businesswire.com/news/home/20210115005074/en/

Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[cheynew]

VBIV up .07 AH.

[RNsidersbuying]

VBI-2900: Prophylactic Coronavirus Vaccine Program

? August 2020: Announcement of pre-clinical data from three mouse studies enabling the selection of two clinical vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine targeting SARS-CoV-2, SARS-CoV, and MERS-CoV; and (2) VBI-2902, a monovalent coronavirus vaccine targeting SARS-CoV-2. Data highlights include:

? Both vaccine candidates have the potential to be one-dose vaccines: After a single dose, VBI’s enveloped virus-like particle (eVLP) candidates expressing a modified, stabilized, pre-fusion form of the SARS-CoV-2 spike protein induced a neutralizing antibody (nAb) geometric mean titer (GMT) 4x higher than that induced by convalescent sera, increasing to 64x higher than high-titer convalescent sera after the second dose
? Trivalent construct increased breadth of reactivity: VBI-2901 further induced antibody binding titers across each of the three expressed spike proteins and also broadened reactivity to HCoV-OC43, a seasonal circulating coronavirus associated with the common cold that was not expressed in the vaccine

? August 2020: Agreement announced with Therapure Biomanufacturing, an integrated Contract Development Manufacturing Organization (CDMO), for development and manufacturing services for production of coronavirus vaccine candidates

? Around Year-End 2020: Initiation of initial adaptive Phase 1/2 human clinical study expected, pending regulatory approvals

https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14473399&RcvdDate=11/2/2020&CoName=VBI%20VACCINES%20INC/BC&FormType=8-K&View=html

[cheynew]

VBI Vaccines Announces European Medicines Agency Acceptance of Marketing Authorization Application (MAA) for 3-Antigen Prophy...
December 23 2020 - 08:00AM
Business Wire
Alert
Print
Share On Facebook
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The acceptance of the MAA filing begins the EMA’s review process.

“The EMA acceptance of our MAA marks an important milestone for VBI in our effort to enable broad access to our 3-antigen prophylactic hepatitis B vaccine, which we believe has the potential to be an important intervention in the fight to eliminate hepatitis B infections,” said Jeff Baxter, President & CEO. “We are committed to working collaboratively with the EMA during the regulatory process and we look forward to communicating developments related to the MAA throughout 2021.”

The MAA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data.

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI’s 3-Antigen Hepatitis B Vaccine

This vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

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 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel under the name Sci-B-Vac® 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 coronavirus vaccine program. 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 source version on businesswire.com: https://www.businesswire.com/news/home/20201223005054/en/

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: [phone] x124
Email: [e-mail]

[now invest]

Looking good here....

[now invest]

See they (RJ) has it at a 9 dollar target with a strong buy rating... opened a position today and already added.... LOL. Good luck here!!

[cheynew]

VBIV Hep B fireside chat this morning at 11 EST.

Virtual fireside chat with analyst Steven Seedhouse, Ph.D., to take place at 11:00 AM ET on December 8, 2020
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that members of the VBI leadership team will discuss the recent news and strategic outlook for the Company’s hepatitis B (HBV) portfolio with covering analyst, Steven Seedhouse, Ph.D., from Raymond James & Associates, Inc. during a fireside chat at 11:00 AM ET on Tuesday, December 8, 2020. The discussion will highlight the Company’s two HBV pipeline candidates: VBI’s 3-antigen prophylactic HBV vaccine candidate, licensed in Israel as Sci-B-Vac ® , and VBI-2601, a novel recombinant, immunotherapeutic candidate for the treatment of chronic HBV infection.

The fireside chat can be accessed live via the Events/Presentations page in the Investors section of the Company’s website, or by clicking this link:

https://raymondjames.zoom.us/webinar/register/WN_i-eY5EFpSAWiQwiAub42Rg .

A replay of the webcast will be archived on the Company’s website following the live conference call.