6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of August 2015

001-37353

(Commission File Number)

BIONDVAX PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

14 Einstein St.

Ness Ziona

Israel 74036

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover

Form 20-F or Form 40-F.

Form 20-F R    Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(7): ____

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ☐    No R

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-N/A

On August 3, 2015, Biondvax Pharmaceuticals Ltd. issued a press release announcing it received the statistical analysis of results from a study which demonstrates that BiondVax’s universal flu vaccine (M-001), administered in the BVX-005 phase II trial which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the time of the study, including against H3N2 influenza strain that caused the epidemic in the United States in 2015. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In addition, below is an English translation (from Hebrew) of an immediate report by BiondVax Pharmaceuticals Ltd. as published on the Tel-Aviv Stock Exchange Ltd. and the Israeli Securities Authority on August 3, 2015, in accordance with the Israeli Securities Regulations.

August 3, 2015

To	To
Israeli Securities Authority	The Tel Aviv Stock Exchange Ltd.

Re: Immediate Report

The Company hereby announces it received the statistical analysis of results from a study which demonstrates that BiondVax’s universal flu vaccine (M-001), administered in the BVX-005 phase II trial which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the time of the study- in particular the current newly emerged H3N2 influenza (flu) strain that caused the epidemic in the United States during the last flu season (2014/2015 season).

BVX-005 was conducted and completed in 2012. This clinical trial included a total of 120 elderly participants aged 65 or over, most of which were treated with M-001 while 30 participants served as a control group. For further details regarding the BVX-005 clinical trial see Company's immediate reports dated August 29, 2011 and February 15, 2012 (reference no.: 2011-01-256488 and 2012-01-043023, respectively).

BiondVax exposed the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist. BiondVax examined the immunogenicity (HAI) antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group. This concurs with the similar results found in BiondVax's recent BVX-006 phase II trial. See Company's immediate report dated June 29, 2015, reference no.: 2015-01-059904.

In addition, attached to this immediate report as Appendix A is a press release for publication in the U.S. regarding the statistical analysis of results, as described hereto.

About M-001 

For more information regarding the company's product candidate and its development stages please see Section 8 to the annual report published on ISA and TASE websites on March 26, 2015, reference number 2015-01-063070 (the "Annual Report").

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Exhibit Index

Exhibit No.	Description
99.1	Press Release, dated August 3, 2015

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	BiondVax Pharmaceuticals Ltd.
Date: August 3, 2015	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

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EX-99.1

Exhibit 99.1

 

Independent Results Show that BiondVax’s Universal Flu Vaccine
Administered in a Trial 3 years ago Improves Immunogenicity against
Current Flu H3N2 Epidemic

Ness Ziona, Israel – August 3, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced it received the statistical analysis of results from a study which demonstrates that BiondVax’s universal flu vaccine (M-001), administered in the BVX-005 phase II trial which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the time of the study- in particular the current newly emerged H3N2 influenza (flu) strain that caused the epidemic in the United States in 2015.

In 2012, 120 elderly participants aged 65 or over, participated in the BVX-005 trial. This trial was concluded successfully, demonstrating induction of both humoral and cellular immune responses to BiondVax’s vaccine and to multiple influenza viruses. In that trial, 90 participants were injected with the M-001 universal flu vaccine a few weeks prior to immunization with TIV (the commercially available seasonal flu vaccine of that time). The remaining group of 30 was a control group which was provided with a placebo followed by the TIV.

Three years later, in 2015, BiondVax exposed the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist.

BiondVax examined the immunogenicity (HAI) antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group. An average of 50% or greater of the participants in the experimental group receiving M-001 showed immunogenicity against this new strain versus only 10% on average in the control group, a result which has statistically high significance.

This concurs with the similar results found in BiondVax's recent BVX-006 phase II trial, showing increased antibody response to the H3N2 epidemic flu strain in those that received BiondVax’s universal vaccine, although it was not included in the commercially available seasonal flu vaccine of the 2014/15 season. Management believe that this data confirms the universal nature of BiondVax's vaccine, protecting against all types of flu strains.

Ron Babecoff, BiondVax’s President and CEO, commented, “We are happy that the participants which received our vaccine in the trial three years ago present a higher immunogenicity, even to actual flu strains in circulation now. The independently provided statistical analysis we reported today is very important as it demonstrates that M-001 provides a safety net by broadening the immunogenicity to existing and future flu strains - in this case, against a specific flu strain that back when the trial was conducted, did not yet exist. If our vaccine was approved by the necessary regulatory bodies and available in the market during the last winter, we believe that the recent epidemic could have been prevented. These results are another important data point showing the importance of our work for global public health and in particular for the elderly which are most vulnerable to this dangerous virus.”

About BiondVax Pharmaceuticals Ltd

BiondVax is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal and pandemic flu strains.

BiondVax’s technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect.

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 involve certain risks and uncertainties 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, uncertainty of clinical trial results or regulatory approvals or clearances, final results from subsequent clinical trials, risks inherent in the development and commercialization of potential products, dependence upon collaborators, and adequacy of capital resources for product development and commercialization. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.

For further information, please contact:

Company Contact Dr Limor Chen, Director of BD limor.c@biondvax.com     Investor Relations Contact GK Investor Relations Kenny Green, Partner +1 646 201 9246 investor.relations@biondvax.com