BVXV BiondVax Pharmaceuticals Ltd.

3.11
-0.15  -5%
Previous Close 3.26
Open 3.26
52 Week Low 2.35
52 Week High 61.9999
Market Cap $35,849,424
Shares 11,527,146
Float 11,527,146
Enterprise Value $64,847,632
Volume 548,518
Av. Daily Volume 1,224,539
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Drug Pipeline

Drug Stage Notes
M-001
Universal flu vaccine
Phase 3
Phase 3
Phase 3 trial did not meet endpoints - October 23, 2020.
M-001
Universal flu vaccine
Phase 2
Phase 2
Phase 2 data met both primary endpoints - June 10, 2020.

Latest News

  1. JERUSALEM, Oct. 23, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a pioneer in the development of a universal flu vaccine designed to provide protection against current, future, seasonal and pandemic influenza, today announced topline data from the Company's pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.  

    BiondVax Pharmaceuticals Logo

    Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints. The study's primary safety endpoint was met.

    "We are disappointed with these results, and I wish to thank the BiondVax team for their efforts, dedication…

    JERUSALEM, Oct. 23, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a pioneer in the development of a universal flu vaccine designed to provide protection against current, future, seasonal and pandemic influenza, today announced topline data from the Company's pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.  

    BiondVax Pharmaceuticals Logo

    Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints. The study's primary safety endpoint was met.

    "We are disappointed with these results, and I wish to thank the BiondVax team for their efforts, dedication, and passion over the past 15 years. Together we have endeavored to develop an innovative approach to a persistent global problem. I am especially grateful to each of the clinical trial participants, as well as the investigators in all our trials for their efforts, and to our stakeholders for their support," said Dr. Ron Babecoff, Founder, President, and Chief Executive Officer. "The significant need for better, more proactive flu protection is well-understood by clinicians and public health experts around the world, and we have devoted many years in pursuit of this worthy goal. Unfortunately, this study did not have the efficacy outcomes that we anticipated for M-001 on a standalone basis. We have observed in seven previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection."

    Dr. Babecoff continued, "We have developed expertise and IP in pursuit of our goals, and we retain a state-of-the-art manufacturing facility. Going forward, we will examine options to maximize the value of these assets."

    About the pivotal Phase 3 trial: The randomized, modified double-blind, placebo-controlled, pivotal Phase 3 trial assessed safety and efficacy of the M–001 vaccine candidate alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older. 4,042 participants were enrolled and randomized in the trial's first cohort prior to the 2018/19 flu season, and an additional 8,421 participants were enrolled across seven Eastern European countries in the trial's second cohort (2019/20 flu season). Each participant was monitored for one flu season.

    The trial commenced in 2018, after the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and provided feedback. The CHMP response included comments regarding various aspects of the trial design, and also stated that, "It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval."

    About BiondVax:

    BiondVax (NASDAQ:BVXV) is a biopharmaceutical company that has been developing M-001, a novel flu vaccine candidate. The vaccine candidate was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. An NIH/NIAID Phase 2 study completed in 2020 showed a significant increase in polyfunctional CD4+ cells in the M-001 group. In a total of seven previously completed Phase 1/2 and Phase 2 clinical trials, the M-001 vaccine candidate was well-tolerated and immunogenic. For more information, please visit www.biondvax.com.

    Company Contact: Joshua E. Phillipson | +972 8 930 2529 |

    Investor Relations: Joseph Green | +1 646 653 7030 |

     

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  2. JERUSALEM, Israel, Oct. 2, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), developer of the Phase 3 clinical trial M–001 universal influenza vaccine candidate ("BiondVax" or the "Company"), today announced it has entered into an agreement with BofA Securities as lead sales agent, and Citigroup and Credit Suisse as participating sales agents (collectively, the "Agents"), related to a $100 million At-The-Market (the "ATM Program") equity offering program pursuant to a prospectus supplement filed today with the Securities and Exchange Commission (the "SEC").

     

    BiondVax Pharmaceuticals Logo

     

    BiondVax is not obligated to sell any American Depositary Shares ("ADSs") under the ATM Program. The timing of any sales will depend on a variety of factors to be determined…

    JERUSALEM, Israel, Oct. 2, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), developer of the Phase 3 clinical trial M–001 universal influenza vaccine candidate ("BiondVax" or the "Company"), today announced it has entered into an agreement with BofA Securities as lead sales agent, and Citigroup and Credit Suisse as participating sales agents (collectively, the "Agents"), related to a $100 million At-The-Market (the "ATM Program") equity offering program pursuant to a prospectus supplement filed today with the Securities and Exchange Commission (the "SEC").

     

    BiondVax Pharmaceuticals Logo

     

    BiondVax is not obligated to sell any American Depositary Shares ("ADSs") under the ATM Program. The timing of any sales will depend on a variety of factors to be determined by BiondVax. The Company currently intends to use the net proceeds from the ATM Program, if any, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes, and pre-commercialization and commercialization activities. We may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that we believe are complementary to our own, although we have no current plans, commitments or agreements with respect to any in-license, investment or acquisition.

    The BiondVax ADSs will be offered and sold through the Agents. Sales of ADSs may be made by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act of 1933, as amended. Sales may be made at market prices prevailing at the time of the sale, at prices related to prevailing market prices or at negotiated prices and, as a result, sales prices may vary.

    Under the terms of the Agreement, BiondVax may also sell ADSs directly to any of the Agents, as principal for its own account, at a price agreed upon at the time of sale. If the Company agrees to sell shares to any Agent as principal, it will enter into a separate terms agreement with such Agent.

    A shelf registration statement was previously filed with the SEC and declared effective by the SEC on August 10, 2020. A prospectus supplement adds to, updates or otherwise changes information contained in the accompanying prospectus and has been filed with the SEC and is available on the SEC's website located at www.sec.gov. Prospective investors should read the prospectus, the prospectus supplement and other documents the Company has filed with the SEC (some of which are incorporated by reference into the prospectus and prospectus supplement) for more complete information about the Company, the ATM Program and the risks the Company currently is facing. You may obtain copies of the prospectus supplement and accompanying prospectus relating to the offering without charge by visiting the SEC's website at www.sec.gov. Alternatively, the issuer, any sales agent or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement if you request them by writing to BofA Securities at NC1-004-03-43,  200 North College Street, 3rd floor, Charlotte NC  28255-0001, Attn: Prospectus Department or emailing , calling Citigroup at 1-800-831-9146 or calling Credit Suisse at 1-800-221-1037 or emailing .

    This press release is for informational purposes only and is not an offer to sell or the solicitation of an offer to buy any ADSs of the Company, which is made only by means of a prospectus supplement and related prospectus. There will be no sale of ADSs in any jurisdiction in which the offer, solicitation of an offer to buy or sale would be unlawful.

    About BiondVax

    BiondVax (NASDAQ:BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial, which enrolled more than 12,400 participants over two flu seasons in 83 sites across seven countries, aims to assess safety and effectiveness of M-001 in reducing flu illness and severity.

    Contact Details

    Joshua E. Phillipson | +972 8 930 2529 |  

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our prospectus filed today and our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. The Company undertakes no obligation to revise or update any forward-looking statement for any reason.

     

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  3. JERUSALEM, Aug. 20, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020.

    Second Quarter 2020 Financial Summary

    Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.466 (NIS/$US) as at June 30, 2020.

    Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

    • R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.
    • Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.

    The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

    As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.

    *Tables to follow*

    About BiondVax

    BiondVax (NASDAQ:BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

    Contact Details

    Joshua E. Phillipson | +972 8 930 2529 |  

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

     

     

    BALANCE SHEETS

    In thousands, except share and per share data



















    Convenience

















    Translation



    December 31







            June 30,



    June 30,



    2019





    2019



    2020



    2020



    Audited





    Unaudited



    Unaudited









    N I S   



    U.S. dollars

    CURRENT ASSETS:

















    Cash and cash equivalents

    72,467





    33,916



    38,752



    11,181

    Other receivables

    656





    1,258



    2,467



    712





















    73,123





    35,174



    41,219



    11,893

    LONG–TERM ASSETS:

















    Property, plant and equipment

    34,981





    32,475



    36,937



    10,658

    Right-of-use assets

    7,136





    7,610



    6,662



    1,922

    Other long-term assets

    510





    510



    891



    257





















    42,627





    40,595



    44,490



    12,837

















    -



    115,750





    75,769



    85,709



    24,730



















    CURRENT LIABILITIES:

















    Trade payables

    17,062





    7,977



    4,070



    1,174

    Operating lease liabilities

    694





    686



    676



    195

    Other payables

    1,203





    1,348



    1,609



    464





















    18,959





    10,011



    6,355



    1,835

    LONG–TERM LIABILITIES:

















    Liability in respect of government grants

    14,812





    14,621



    12,686



    3,660

    Operating lease liabilities

    6,809





    7,076



    6,457



    1,863

    Loan from others

    123,780





    110,971



    122,041



    35,211

    Warrants

    16,354





    5,517



    -



    -

    Severance pay liability, net

    89





    86



    92



    26





















    161,844





    138,271



    141,276



    40,760

    SHAREHOLDERS' EQUITY:

















    Ordinary shares of no par value: Authorized:

           600,000,000, 391,000,000 and

           600,000,000 shares at June 30, 2020 and

           2019 (unaudited) and December 31, 2019,

           respectively; Issued and outstanding:

           460,822,640, 261,419,599 and

           402,351,657 shares at June 30, 2020 and

           2019 (unaudited) and December 31, 2019,

          respectively

    *)   -





    *)   -



    *)   -



    *)   -

    Share premium

    255,285





    185,454



    304,089



    87,735

    Accumulated deficit

    (320,338)





    (257,967)



    (366,011)



    (105,600)





















    (65,053)





    (72,513)



    (61,922)



    (17,865)





















    115,750





    75,769



    85,709



    24,730



    *)            Represents less than NIS\USD 1.

     



     

     

    STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

    In thousands, except share and per share data



























    Convenience

    translation







    Year ended

    December 31,



    Three months ended

    June 30,



    Six months ended

    June 30,



    Six months

    ended

    June 30,







    2019



    2019



    2020



    2019

    2020



    2020







    Audited



    Unaudited



    Unaudited







    N I S



    U.S. dollars







    (In thousands, except per share data)



    Operating expenses:

























    Research and development, net of

        participations



    68,645



    15,172



    11,948



    20,904



    31,016



    8,949



    Marketing, general and administrative



    9,706



    4,518



    4,139



    5,951



    5,120



    1,477































    Total operating expenses



    78,351



    19,690



    16,087



    26,855



    36,136



    10,426



























    -



    Operating loss



    (78,351)



    (19,690)



    (16,087)



    (26,855)



    (36,136)



    (10,426)



    Financial income



    4



    -



    (11,291)



    24



    5,211



    1,503



     

    Financial expense



    (30,847)



    (27,699)



    (14,600)



    (19,992)



    (14,748)



    (4,255)































    Net loss 



     

    (109,194)



    (47,389)



    (41,978)



    (46,823)



    (46,673)



    (13,177)































    Basic and diluted net loss per share

        (NIS)



    (0.33)



    (0.18)



    (0.10)



    (0.18)



    (0.11)



    (0.03)































    Weighted average number of shares

        outstanding used to compute basic

        and diluted loss per share



    326,651,721



    261,482,786



    433,498,227



    261,435,179



    431,485,801



    431,485,801































     

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  4. JERUSALEM, Aug. 13, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), developer of the Phase 3 clinical trial M–001 universal influenza vaccine candidate, today announced that the Annual General Meeting of Shareholders of the Company will be held on September 2, 2020 in Tel Aviv, Israel. Details, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/1611747/000121390020020357/ea125062-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures. Note that votes must be received prior to the deadline noted on the proxy.

     

    BiondVax Pharmaceuticals Logo

     

    Clinical trial update: BiondVax currently anticipates announcing results from the pivotal Phase…

    JERUSALEM, Aug. 13, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), developer of the Phase 3 clinical trial M–001 universal influenza vaccine candidate, today announced that the Annual General Meeting of Shareholders of the Company will be held on September 2, 2020 in Tel Aviv, Israel. Details, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/1611747/000121390020020357/ea125062-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures. Note that votes must be received prior to the deadline noted on the proxy.

     

    BiondVax Pharmaceuticals Logo

     

    Clinical trial update: BiondVax currently anticipates announcing results from the pivotal Phase 3 clinical trial in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.

    About BiondVax

    BiondVax (NASDAQ:BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

    Contact Details

    Joshua E. Phillipson | +972 8 930 2529 |  

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

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  5. JERUSALEM, July 1, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) today announced that all participants in the placebo-controlled, blinded, pivotal, clinical efficacy, Phase 3 trial of BiondVax's M–001 universal influenza vaccine candidate have now completed their site visits. In total, over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled in the trial over the past two flu seasons in 83 sites across seven European countries. The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate (as a primary endpoint) and severity (as a secondary endpoint), as well as to assess…

    JERUSALEM, July 1, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) today announced that all participants in the placebo-controlled, blinded, pivotal, clinical efficacy, Phase 3 trial of BiondVax's M–001 universal influenza vaccine candidate have now completed their site visits. In total, over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled in the trial over the past two flu seasons in 83 sites across seven European countries. The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate (as a primary endpoint) and severity (as a secondary endpoint), as well as to assess M-001's safety.

    BiondVax Pharmaceuticals Logo

    Seasonal influenza annually infects approximately 10-20% of the world's population[1] resulting in up to about five million cases of severe illness and 650,000 deaths[2]. In addition, pandemic influenza, such as the H1N1 Swine Flu pandemic of 2009, is a constant global threat. However, current influenza vaccines, which target frequently mutating parts of the flu virus and therefore must be updated annually in the hope they will match the next flu season's circulating strains, achieve on average only about 40% vaccine effectiveness in the general population[3] and as low as 12% in older adults[4].

    BiondVax's M-001 is a single recombinant protein of highly conserved influenza epitopes. Consequently:

    • M-001 does not need to be updated and therefore can be manufactured and distributed year-round.
    • M-001 is designed to provide protection to both existing and future seasonal A and B strains, as well as emerging pandemic strains.

    Dr. Tamar Ben-Yedida, BiondVax's Chief Scientist, commented, "We are pleased that despite the ongoing COVID-19 pandemic, and the challenge of conducting the trial across 83 sites and seven countries, thanks to all the people involved – including the CRO, investigators, and thousands of participants – we have maintained the planned timelines of our pivotal Phase 3 trial. In light of the ongoing COVID-19 pandemic, the need for improved influenza vaccines has arguably never been clearer. To better protect lives and economies, influenza vaccines must be more effective in reducing illness rates and severity. Needless to say, we are eagerly anticipating results of our trial by the end of this year."

    Participants in the trial's second cohort were enrolled prior to the 2019/20 flu season and monitored for influenza-like illness (ILI) symptoms throughout the flu season. Swabs samples were collected from those participants with ILI, and influenza confirmation is currently being conducted by a qualified laboratory. Analysis will continue in the coming months, and results are expected by the end of 2020.

    As part of this Phase 3 study, cell-mediated immunogenicity markers of M-001 will be evaluated in a subset of participants. The recently completed clinical study report (CSR) of a U.S. National Institute of Allergy and Infectious Diseases (NIAID) supported Phase 2 clinical trial of M-001 concluded that, "M-001 induced significant polyfunctional T cell responses."

    In addition to the ongoing pivotal, clinical efficacy, Phase 3 trial, equipment installation and manufacturing process scale-up in BiondVax's pilot facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.

    About BiondVax

    BiondVax (NASDAQ:BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

    Contact Details

    Joshua E. Phillipson | +972 8 930 2529 |  

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

    References

    [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596521/

    [2] https://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal)

    [3] https://www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm

    [4] https://www.cdc.gov/flu/vaccines-work/2018-2019.html

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    SOURCE BiondVax Pharmaceuticals Ltd.

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