DVAX Dynavax Technologies Corp

 

 

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  09/22/2014

 

Dynavax Technologies Corporation

(Exact name of registrant as specified in its charter)

 

Commission File Number:  001-34207

 

 

2929 Seventh Street, Suite 100

Berkeley, CA 94710-2753

(Address of principal executive offices, including zip code)

 

(510) 848-5100

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Item 8.01.    Other Events

 

On September 22, 2014, we issued a press release titled "Dynavax Completes Enrollment of Phase 3 Study of HEPLISAV-B™." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.

 

 

Item 9.01.    Financial Statements and Exhibits

 

(d) Exhibits. The following exhibit is furnished herewith:

99.1 Press Release, dated September 22, 2014, titled "Dynavax Completes Enrollment of Phase 3 Study of HEPLISAV-B™"

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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 hereunto duly authorized.

 

 

 

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EXHIBIT INDEX

 

 

 

 

 

Exhibit 99.1

 

2929 Seventh Street, Suite 100

Berkeley, CA 94710

 

 

 

DYNAVAX COMPLETES ENROLLMENT OF PHASE 3 STUDY of HEPLISAV-B™

 

BERKELEY, CA – September 22, 2014 – Dynavax Technologies Corporation (NASDAQ: DVAX) today announced completion of planned enrollment in the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine.  More than 8,250 adults, including over 1,100 diabetic subjects, have been enrolled at 40 sites in the U.S.

 

This large safety and immunogenicity study (known as HBV-23) is intended to provide an adequately-sized database of vaccinated subjects to enable the U.S. Food and Drug Administration to complete its review of the pending HEPLISAV-B Biologics License Application.  The study is also designed to assess the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus.

 

“Concluding enrollment of HBV-23 is a major milestone in the path to potential approval of HEPLISAV-B. I am pleased with the team’s efforts to complete this key phase of the trial three months ahead of schedule” said Eddie Gray, Chief Executive Officer of Dynavax. “HEPLISAV-B is the most advanced demonstration of our leadership in TLR biology and validates our targeted approach to modulating the immune system to prevent and treat disease.”

 

HBV-23 is an observer-blinded, randomized, active-controlled trial.  Adult subjects between the ages of 18 and 70 have been randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B^®.  Safety follow up will continue for 12 months following each subject’s second vaccination.  All study visits will be completed by October, 2015.

 

Additional details regarding HBV-23 are available at www.clinicaltrials.gov.

 

About HEPLISAV-B

 

HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

 

 

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About Dynavax

 

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

 

Forward-Looking Statements

This press release contains "forward-looking" statements, including expectations for the conduct, timing and sufficiency of HBV-23. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether a sufficient number of subjects enrolled in HBV-23 complete the study; whether successful clinical and regulatory development and review and approval of HEPLISAV-B and our process for its manufacture can occur without significant delay or additional studies; whether our studies and manufacturing efforts are sufficient to support registration for commercialization of HEPLISAV-B; our ability to obtain additional financing to support the development and commercialization of HEPLISAV-B and our other operations; possible claims against us, including enjoining sales of HEPLISAV-B, based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

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