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 October 2015

001-37353

(Commission File Number)

BIONDVAX PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

14 Einstein St.

Nes 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 þ  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 þ

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

On October 21, 2015, Biondvax Pharmaceuticals Ltd. issued a press release announcing successful recruitment of the first participants in a Phase IIb clinical trial in Europe with its Universal Flu Vaccine: Multimeric M-001. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Exhibit Index

Exhibit No.	Description
99.1	Press Release, dated October 21, 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: October 21, 2015	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

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EX-99.1

Exhibit 99.1

 

PRESS RELEASE

BiondVax Announces Successful Recruitment of the First Participants in a Phase IIb Clinical Trial in Europe with its Universal Flu Vaccine: Multimeric M-001

Trial in line with BiondVax clinical plan for Phase 3 trial in 2017/18

Nes Ziona, Israel – October 21, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has successfully recruited the first two participants in this trial, BVX-007. The trial is being conducted in Budapest, Hungary at the St Istvan and St Lazslo Hospital, as well as additional satellite sites in Hungary, together with the partners from the UNISEC European Consortium.

This phase IIb trial will include 222 adults. It is designed to evaluate the safety and immunogenicity of the Universal influenza vaccine when used ahead of an avian influenza vaccine (provided by FluArt, Hungary). The avian influenza vaccine will be given only once, at a sub-optimal dose, aiming to show the dose sparing potential of the universal vaccine when given prior to the avian vaccine, a highly desirable feature in a pandemic scenario, where existing stockpiles of vaccine may not be sufficient.

Eligibility criteria for the trial include participants aged 18-60 years in good health that do not suffer from immune deficiencies and were not vaccinated against Influenza in the 6 months prior to the trial. Results are expected in the second half of 2016.

Tamar Ben-Yedidia, CSO of BiondVax commented, “The trial will provide insight into the ability of BiondVax’s universal vaccine to stimulate broad immunity to influenza viruses including the highly pathogenic H5N1 bird flu virus. It is clear that a universal vaccine for influenza, that will also cover this aggressive and particularly dangerous strain is greatly needed.”

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.

Weizmann Science Park, 14 Einstein Street, PO Box 4143, Nes Ziona 7414002, Israel
Tel: +972 8 930 2529 ● Fax:+972 8 930 2531 ● www.biondvax.com

 

Forward Looking Statements  

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. 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, the outcome, cost and timing of our clinical trials, the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results, our ability to obtain and maintain regulatory approval of our Universal Flu Vaccine, our ability to achieve market acceptance of our Universal Flu Vaccine; unanticipated costs or delays in research, development and commercialization efforts, the applicability of clinical study results to actual outcomes, our ability to continue obtaining and maintaining intellectual property protection for our Universal Flu Vaccine, 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 and others 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 Limor Chen, Director of BD limor.c@biondvax.com Investor Relations Contact GK Investor Relations Kenny Green, Partner +1 646 201 9246 kenny@biondvax.com

Weizmann Science Park, 14 Einstein Street, PO Box 4143, Nes Ziona 7414002, Israel
Tel: +972 8 930 2529 ● Fax:+972 8 930 2531 ● www.biondvax.com