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 September 30, 2015, Biondvax Pharmaceuticals Ltd. (the "Company") issued a press release announcing that the Company received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase llb clinical trial. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In addition, On October 1, 2015, the Company issued a press release announcing that the Company has entered into a Development and Manufacturing Agreement for the production of clinical batches of its universal flu vaccine, M-001, with Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), based in Oklahoma, USA. A copy of this press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Exhibit Index

Exhibit No.	Description
99.1	Press Release, dated September 30, 2015
99.2	Press Release, dated October 1, 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 1, 2015	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

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EX-99.1

Exhibit 99.1 

 

PRESS RELEASE

BiondVax Initiates a Phase IIbClinical Trial in Europe for its Universal Flu Vaccine for Pandemic Outbreak

The regulatory approval was received for the trial enabling BiondVax to examine its vaccine as a primer for an Avian (H5N1) flu pandemic outbreak in collaboration with the UNISEC European Consortium

Nes Ziona, Israel – September 30, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase IIb clinical trial. The initiation meeting was scheduled for today, September 30, 2015, together with the partners from the UNISEC European Consortium.

This phase IIb trial is a multicenter, randomized, double-blind, active-controlled trial. It is being conducted under the auspicies of an EU-funded UNISEC project, assessing the immunogenicity and safety of BiondVax’s universal influenza vaccine (Multimeric-001), followed by an administration of the H5N1 influenza vaccine. The trial will include 222 healthy adults aged 18-60 years, a group representing the target population for receiving vaccines when a pandemic outbreak occurs.

The trial is primarily being conducted at the St. Istvan and St. Laszlo Hospital in Budapest, Hungary as well as additional satellite sites in the country. Recruitment of participants for the trial has started, and results are expected in the second half of 2016.

Utilizing the clinical trial network and specialised laboritories of UNISEC’s consortium, BiondVax is initiating this clinical study to examine the benefits of priming with BiondVax's universal flu vaccine. This new approach enables public health authorities to be proactive and prepared in advance of any flu pandemic outbreak, by building a national stockpile of the universal flu vaccine. This allows vaccinations to start immediately upon any pandemic outbreak, compared to the current-day situation, whereby there is a delay of approximately 6 months due to the manufacture of the pandemic strain specific vaccine. In addition, BiondVax has demonstrated in previous trials that using its vaccine as a primer provides additional protection against flu strains in the current TIV (current seasonal flu vaccine) as well as drifted strains not included in this vaccine.

The current trial is led by Prof. Dr. Eelko Hak, Trial Coordinator on behalf of the UNISEC consortium from the University of Groningen, Netherlands and Dr. Zsofia Meszner, General Director of the National Institute of Child Health from St. Istvan and St. Laszlo Hospital, as Principle Investigator and Dr. Dora Mathiazs the Strategic Director of the hospital. BiondVax, as well as other partners of the UNISEC consortium including RKI, Berlin and NCE, Budapest, will be involved in the immunogenicity testing of the cellular and humoral responses.

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

 

To date, BiondVax has successfully completed five clinical trials (two phase I/II and three phase II), conducted with 479 participants for its Universal Flu Vaccine. The vaccine was found safe, effective, and capable of triggering both cellular and humoral responses of the human immune system, against different strains of the influenza virus including existing and future strains.

Tamar Ben-Yedidia, CSO of BiondVax commented, “I am pleased to see our clinical program taking a significant step forward. This marks our progression to the international phase of our clinical development program, with trials now starting in Europe and soon in the United States in collaboration with the NIAID/NIH as we recently announced.”

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. 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

EX-99.2

Exhibit 99.2

 

PRESS RELEASE

BiondVax Establishes Capability for the Manufacture of Clinical Grade Universal Flu Vaccine for

Phase III Clinical Trials

Selects Cytovance Biologics Inc. for the production of clinical batches of M-001

Nes Ziona, Israel – October 1, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has entered into a Development and Manufacturing Agreement for the production of clinical batches of its universal flu vaccine, M-001, with Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), based in Oklahoma, USA.

Under the terms of the Agreement, Cytovance Biologics will scale up and optimize the small-scale cGMP manufacturing process of M-001, previously developed by BiondVax for its phase I and phase II clinical trials. The current production process developed at BiondVax has passed an audit by a European Qualifying Person (QP). The technology transfer will start immediately, with the initial clinical batches expected to be manufactured by the end of 2016. The clinical grade M-001 batch is intended to be used by BiondVax for its phase III trial, planned for the 2017/18 timeframe, which is a critical step towards commercialization of M-001 in the US, Europe and the rest of the world.

Shimon Hassin, COO of BiondVax commented: “I am happy and proud of this new strategic relationship with Cytovance Biologics Inc., a U.S. leader in contract manufacturing with a significant track record in the production of clinical materials. This is a key development for BiondVax that will play a major role in accelerating the clinical development and large scale manufacture of our universal flu vaccine, M-001. I believe that our vaccine will improve the lives of the millions of individuals who currently suffer and some of which die every year, from Influenza and its complications.”

Darren Head, CEO and President of Cytovance added: “Cytovance’s state-of-the-art facilities and staff are prepared to deliver the highest quality of manufacturing services for BiondVax.”

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

 

About Cytovance Biologics Inc.

Cytovance Biologics is a contract development manufacturing company specializing in the cGMP production of therapeutic proteins and antibodies from mammalian cell culture, microbial fermentation, transgenic processes, and small scale "flex suite" programs. In addition, Cytovance offers process development services, cell line development, purification development, stability testing, and regulatory support services -- all from its Oklahoma City state-of-the-art facilities.

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 timely manufacture of clinical grade materials for the Phase III Clinical trials, 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 achieve market acceptance of our Universal Flu Vaccine, 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