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News Article | July 11, 2017
Site: www.marketwired.com

Conference Call and Webcast: Wednesday, July 12, at 8:30 a.m. EDT CAMBRIDGE, MASSACHUSETTS--(Marketwired - July 11, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI") announced today its plans for a global Phase 3 clinical program for Sci-B-Vac™, its third-generation hepatitis B vaccine, following positive discussions with the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada. The Phase 3 program will be a global 15-month program and will consist of two concurrent Phase 3 studies - a safety and immunogenicity study (PROTECT) and a lot-to-lot consistency study (CONSTANT), enrolling a total of approximately 4,800 subjects. The Phase 3 program will be conducted at approximately 40 sites across the U.S., Europe, and Canada. "We consider the outcome of discussions with the FDA, EMA, and Health Canada to be extremely positive," said Jeff Baxter, president and CEO of VBI. "Sci-B-Vac's extensive safety and efficacy data package demonstrates safe and effective vaccination of approximately 2,000 subjects in past clinical trials. Because of this track record, we are able to plan a Phase 3 program that will enroll only 4,800 subjects in total and will be only 15-months in duration. We anticipate initiating enrollment in both Phase 3 studies in the second half of 2017." PROTECT will be a double-blind, two-arm, randomized, controlled study. Approximately 1,600 adult subjects, age 18 years and older, will be randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10μg or a three-dose course of the control vaccine, Engerix-B® 20μg. Enrollment will be stratified by age group. The co-primary objectives of the study will be: The study will also include multiple secondary objectives to evaluate the speed to seroprotection and the overall safety and tolerability of Sci-B-Vac vs. Engerix-B®. CONSTANT will be a double-blind, four-arm, randomized, controlled study. Approximately 3,200 adult subjects, age 18-45 years, will be randomized in a 1:1:1:1 ratio to receive one of four three-dose courses: Lot A of Sci-B-Vac 10μg, Lot B of Sci-B-Vac 10μg, Lot C of Sci-B-Vac 10μg, or the control vaccine Engerix-B® 20μg. The primary objective of this study will be: The secondary objective will be to evaluate safety and efficacy of Sci-B-Vac vs. Engerix-B®. VBI Vaccines will host a conference call and webcast with accompanying slides Wednesday, July 12, 2017, at 8:30 a.m. EDT, to provide a clinical and regulatory update on Sci-B-Vac. The webcast can be watched via the event link in the "Events/Presentations" section under the "Investor" page of the VBI corporate website at www.vbivaccines.com or by clicking this link: To dial in to the conference call, please dial: Toll-free US & Canada Dial-In: 888-857-6932 International Dial-In: 719-457-2603 Conference ID: 9006835 A replay of the webcast will be available on VBI's website for 45 days after the event. Sci-B-Vac™ is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 300,000 patients. Sci-B-Vac is currently approved for use in Israel and in 14 other countries. In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac may prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines. To learn more about Sci-B-Vac™, visit: https://www.vbivaccines.com/sci-b-vac/ VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase III clinical studies, the provision of additional information about clinical studies, and the potential effects of Sci-B-Vac™. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties' respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


Well tolerated at all doses with no safety signals 100% seroconversion at highest dose after two of the three planned vaccinations Full data after third dose expected first half of 2018 CAMBRIDGE, MASSACHUSETTS--(Marketwired - July 27, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive results from a planned, interim data read-out from a Phase 1 study of its preventative cytomegalovirus (CMV) vaccine. This interim data read-out analyzed safety data through day 84 of the study and initial immunogenicity signals in participant samples collected one month after the second of three planned vaccine doses: "This pre-planned interim read-out has provided us with an excellent early look at the safety and immunogenicity of our CMV vaccine candidate," said Jeff Baxter, president and CEO of VBI. "The safety and tolerability data is critical, as this is the first-in-humans clinical study with a candidate generated from our enveloped virus-like particle (eVLP) technology. Moreover, we saw 100% seroconversion in subjects who received the highest dose of VBI-1501A, a dose-dependent boosting response, and development of neutralizing antibodies in some patients after two doses, providing us with confidence at this point that our vaccine is working as we intended. We look forward to seeing the final three-dose data in the first half of 2018." Joanne Langley, MD, professor of pediatrics in the Division of Infectious Disease at Dalhousie University and principal investigator of the study, commented, "we are encouraged by this interim data, which provide early evidence that VBI's eVLP CMV candidate has the potential to safely and effectively induce seroconversion and elicit neutralizing antibody titers." David Anderson, Ph.D., VBI Chief Scientific Officer, further commented, "induction of neutralizing antibodies that prevent epithelial cell infection has been a challenge for past CMV vaccines. The fact that we observe neutralizing activity against epithelial cell infection after just two doses is promising." This study is a Phase I randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of VBI's preventative CMV vaccine in healthy adults. The study enrolled 128 CMV-negative subjects, aged 18-40 years, who were randomized into five arms to receive various dose levels of a modified form of gB, gB-G, with or without the adjuvant alum, or placebo: Patients were vaccinated at zero, two, and six months. VBI reported that all patients had received the third and final vaccination in May 2017. Final safety data through day 336 of the study and final immunogenicity data based on subject samples collected after the third vaccination is expected in the first half of 2018. Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798. VBI Vaccines will host a conference call and webcast with accompanying slides on Thursday, July 27, 2017, at 1:00 p.m. EDT, to provide a clinical update on VBI-1501A, its preventative CMV vaccine. The webcast can be watched via the event link in the "Events/Presentations" section under the "Investor" page of the VBI website at www.vbivaccines.com or by clicking this link: A replay of the webcast will be available on VBI's website for 45 days after the event. CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and developmental delays. CMV affects more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement. To learn more about CMV, visit: https://www.vbivaccines.com/cmv/ VBI Vaccines Inc. (VBI) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. 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 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, including patent protection. 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 Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2017, and filed with the Canadian security authorities at sedar.com on March 24, 2017, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


News Article | June 26, 2017
Site: www.marketwired.com

CAMBRIDGE, MASSACHUSETTS--(Marketwired - June 26, 2017) - VBI Vaccines, Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, announced today that it has been added to the Russell 2000® and the Russell 3000® Indexes following the annual reconstitution, which took effect after the US market closed on Friday, June 23rd. "Inclusion in the Russell 2000® and 3000® Indexes is an important milestone for VBI that further validates the growing shareholder value we are building within VBI," said Jeff Baxter, VBI's President and CEO. "The Russell Indexes are closely followed by the investment community and we believe inclusion in these indexes will bring increased exposure and visibility for VBI." The Russell 3000® Index measures the performance of the largest 3,000 U.S. companies, representing approximately 98% of the investable U.S. equity market. The Russell 2000® Index measures performance of the small-cap segment of the U.S. equity market and is a subset of the Russell 3000® Index, representing approximately 10% of the total market capitalization of the Russell 3000® Index. Membership in the Russell 2000® Index results in automatic inclusion in the appropriate growth and style indexes. Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $8.5 trillion in assets are benchmarked to or invested in products based on the Russell U.S. Indexes. Russell Indexes are provided by FTSE Russell, a leading global index provider. For more information, visit: https://www.ftserussell.com/research-insights/russell-reconstitution. VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B ("HBV") vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus ("CMV") and glioblastoma multiforme ("GBM"). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties' respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


VBI-1901 is a novel immunotherapy developed using VBI's eVLP technology On track to initiate a Phase I/2a clinical study in the second half of 2017 CAMBRIDGE, MASSACHUSETTS--(Marketwired - Aug. 15, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV) (TSX:VBV) (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 the company's Investigational New Drug Application (IND) for VBI-1901, a novel immunotherapy targeting Glioblastoma Multiforme (GBM), one of the most common and aggressive malignant primary brain tumors in humans. The IND enables VBI to initiate a multi-center Phase I/2a clinical study evaluating VBI-1901 in patients with recurrent GBM in the second half of this year. VBI has leveraged its enveloped virus-like particle (eVLP) platform and expertise in immunology to develop a broadly active therapeutic vaccine that targets two highly immunogenic CMV antigens, gB and pp65, to direct a potent immune response against CMV infection. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including GBM. The vaccine candidate is combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), an adjuvant that mobilizes dendritic cell function and seeks to enhance productive immunity against tumors. "A growing body of research has demonstrated that GBM tumors may be susceptible to infection by CMV, with over 90% of GBM tumors expressing CMV antigens," said Jeff Baxter, president and CEO of VBI. "FDA clearance of this IND is a significant milestone for VBI as we expand our eVLP platform into immuno-oncology applications." Glioblastoma is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, with median patient survival of less than 16 months. Targeted immunotherapy may provide a promising adjunct or alternative to conventional GBM treatment. Immunotherapy is a fundamentally different way of treating cancer that stimulates the patient's immune system to resume its attack on tumors. While conventional therapies are non-specific and may damage surrounding normal tissues, targeted immunotherapy may offer a highly specific and potentially long-lasting treatment approach that leverages the immune system to protect against cancer. Developing a broadly applicable GBM immunotherapy requires the identification of antigens that are consistently expressed on GBM tumor cells. Recent research has demonstrated that an anti-CMV dendritic cell vaccination regimen may extend overall survival in patients with GBM. Thus, effective targeting of CMV antigens may represent an attractive strategy for a GBM immunotherapy. To learn more about VBI's GBM immunotherapy program, visit: http://www.vbivaccines.com/gbm/ VBI Vaccines Inc. (VBI) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency and safety. VBI is headquartered in Cambridge, Mass., with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. 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 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, including patent protection. 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 Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2017, and filed with the Canadian security authorities at sedar.com on March 24, 2017, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


News Article | June 5, 2017
Site: www.marketwired.com

CAMBRIDGE, MASSACHUSETTS--(Marketwired - June 5, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that Jeff Baxter, VBI's President and CEO, will present at the Jefferies 2017 Global Healthcare Conference on Friday, June 9, 2017 at 12:30 PM ET in New York City. At the time of the presentation, a live audio webcast will be available at: http://wsw.com/webcast/jeff105/vbiv VBI recommends registering for the webcast at least ten minutes prior to the start of the presentation to ensure timely access. A replay of the webcast will be available on the VBI website for 90 days following the event. VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B ("HBV") vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology enables the development of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus ("CMV") and glioblastoma multiforme ("GBM"). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "may", "plan", "will", and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


News Article | June 28, 2017
Site: www.marketwired.com

CAMBRIDGE, MASSACHUSETTS--(Marketwired - June 28, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI") today announced the voting results from its annual general and special meeting (the "Meeting") held on June 22, 2017. 30,823,557 common shares were represented at the Meeting, totaling 76.94% of VBI issued and outstanding common shares. The shareholders voted on and approved all matters brought before the Meeting, including: the appointment of EisnerAmper LLP as VBI's auditors, the authorization of the directors to fix their remuneration, the election of VBI's directors, the advisory resolution to hold an advisory vote on executive compensation every three years, the advisory resolution to approve VBI's approach to executive compensation, and the resolution to ratify and confirm common share issuances to certain VBI consultants. Detailed results of the vote for the election of directors are provided below: VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B ("HBV") vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus ("CMV") and glioblastoma multiforme ("GBM"). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties' respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S. Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


— Global Rabies Treatment Market Information, by Type (Furious Rabies, Paralytic Rabies and others), by Treatment (Rabies Immunoglobulin Vaccine, Brain Tissue Vaccines, Tissue Culture Vaccines and others), by End Users (Hospital, Clinics, Epidemic Prevention Centers and others) - Forecast to 2022 Rabies is a life-threatening condition that causes tens of thousands of deaths worldwide every year. It is a disease, where humans may get from being bitten by an animal infected with the rabies virus. It gets transmitted through saliva touching an open wound or touching mucous membranes. This virus infects the brain and ultimately leads to death. Study Objectives of Rabies Treatment Market: • To provide detailed analysis of the market structure along with forecast for the next 7 years of the various segments and sub-segments of the rabies treatment market • To provide insights about factors affecting the market growth • To analyze the rabies treatment market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. • To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia-Pacific, and Middle East & Africa. • To provide country level analysis of the market with respect to the current market size and future prospective • To provide country level analysis of the market for segments by type, by treatment, by end users and its sub-segments. • To provide overview of key players and their strategic profiling in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market • To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the global rabies treatment market. Intended Audience: • Companies into Rabies treatment • Research and Development (R&D) Companies • Independent Research Laboratories • Market Research and Consulting Service Providers • Medical Research Laboratories Global rabies treatment market has been segmented on the basis of type which comprise of Furious Rabies, Paralytic Rabies and others. On the basis of treatment; market is segmented into; Rabies immunoglobulin vaccine, Brain tissue vaccines, Tissue culture vaccines and others. On the basis of end users; market is segmented as; hospital, clinics, epidemic prevention centers and others. Key Players for Rabies Treatment Market: • Sanofi (France) • Merck Animal Health • CSC PHARMACEUTICALS INTERNATIONAL • Pfizer (US) • VBI Vaccines Inc. (US) • Taj Pharmaceuticals Limited. (India) • Bio Med Pvt. Ltd Request for Table of Content at https://www.marketresearchfuture.com/request-toc/1629 . The report for Global Rabies Treatment Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions For more information, please visit https://www.marketresearchfuture.com/reports/rabies-treatment-market


CAMBRIDGE, MASSACHUSETTS--(Marketwired - June 19, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, announced today that it has completed a pre-Investigational New Drug ("IND") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the Phase III clinical program for Sci-B-Vac™, VBI's third-generation hepatitis B vaccine. Sci-B-Vac™ is currently approved for use in Israel and 14 other countries worldwide. Based on the regulatory feedback from its meeting with the FDA, VBI can confirm that the initial IND for Sci-B-Vac™ will not require any additional clinical studies to support its pivotal, global Phase III clinical program. VBI plans to submit the IND in the second half of 2017, together with the Clinical Trial Applications ("CTAs") for Europe and Canada. "The successful completion of our pre-IND meeting with the FDA is a significant milestone in the development of Sci-B-Vac™. Following similar positive discussions with the European Medicines Agency and Health Canada, we now have a strong indication from all three regulatory agencies that Sci-B-Vac™ is Phase III-ready in the U.S., Europe, and Canada," said Jeff Baxter, VBI's President and CEO. "VBI is now in the process of preparing a Phase III IND for the U.S., and CTAs for Europe and Canada, with submission planned in the second half of 2017. Additional details about the global Phase III clinical program will be available at the time the IND and CTA submissions are made." Sci-B-Vac™ is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 300,000 patients. Sci-B-Vac™ is currently approved for use in Israel and in 14 other countries. In contrast to currently licensed second-generation hepatitis B vaccines, which contain only one surface antigen (the small S antigen), Sci-B-Vac™ contains the S antigen and the larger pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac™ may prove more effective and safe, meeting an unmet medical need in individuals that do not respond optimally to second-generation hepatitis B vaccines. To learn more about Sci-B-Vac™, visit: https://www.vbivaccines.com/sci-b-vac/. VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B ("HBV") vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus ("CMV") and glioblastoma multiforme ("GBM"). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase 3 clinical studies, the provision of additional information about clinical studies, the potential effects of Sci-B-Vac™, and the timeline for the submission of the IND. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties' respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


News Article | September 12, 2017
Site: www.marketwired.com

CAMBRIDGE, MASSACHUSETTS--(Marketwired - Sept. 12, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (VBI) today announced that Jeff Baxter, President and CEO, will provide a corporate overview and update at two investor conferences in September. Live webcasts will be available on the Investors page of VBI's website at: www.vbivaccines.com/investors/events-presentations/. A replay of each presentation will be available at the same location for 90 days following the events. VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma multiforme (GBM). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that enables vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. 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 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, including patent protection. 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 Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2017, and filed with the Canadian security authorities at sedar.com on March 24, 2017, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


CAMBRIDGE, MASSACHUSETTS--(Marketwired - Feb. 22, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI") announced today that the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada expressed its general support and acceptance of the company's development path for its Sci-B-Vac™ vaccine, a prophylactic vaccine against hepatitis B, in a pre-Clinical Trial Application ("CTA") meeting. A complete CTA must be filed with and approved by BGTD, and all conditions of BGTD must be met, prior to the initiation of a clinical program in Canada. Given the extensive manufacturing data, licensed clinical efficacy and safety experience of Sci-B-Vac™, BGTD agreed in principle with the overall development strategy of VBI. In addition, BGTD agreed that the proposed Phase III program would satisfy the regulatory requirements for marketing authorization in Canada, supporting the indication for active immunization against hepatitis B in adults. Sci-B-Vac™ fills a significant gap in an unmet medical need to protect against hepatitis B, especially in older individuals who may not be protected with currently licensed hepatitis B vaccines. "We are delighted that Health Canada has expressed its support of the Sci-B-Vac™ Phase III program in Canada," said Francisco Diaz-Mitoma, M.D., Ph.D., VBI's Chief Medical Officer. "This feedback is encouraging and enables us to submit the formal CTA to Health Canada in the first half of 2017. It also further validates the positive feedback VBI received last month from the European Medicines Agency ("EMA")." VBI is seeking evaluation and approval from the U.S. Food and Drug Administration ("FDA"), the BGTD, and the EMA for the pivotal Sci-B-Vac™ global Phase III clinical studies. VBI plans to provide additional information about the clinical studies upon completion of discussions with these regulatory agencies. Sci-B-Vac™ is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 300,000 patients. Sci-B-Vac™ is currently approved for use in Israel and in 14 other countries. In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac™ contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac™ may prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines. To learn more about Sci-B-Vac™, visit: https://www.vbivaccines.com/sci-b-vac/. VBI Vaccines Inc. ("VBI") is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI's first marketed product is Sci-B-Vac™, a hepatitis B ("HBV") vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI's eVLP Platform technology allows for the development of enveloped ("e") virus-like particle ("VLP") vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus ("CMV") and glioblastoma multiforme ("GBM"). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel. Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, "forward-looking statements") that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words "may", "plan", "will", and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase III clinical studies, the provision of additional information about clinical studies, and the potential effects of Sci-B-Vac™. Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company's products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations. Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company's products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company's reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company's current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

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