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):   March 2, 2015

 

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 March 2, 2015, we issued a press release titled "Dynavax Announces Second Independent DSMB Recommendation to Continue Phase 3 Study of Heplisav-B^TM." 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 March 2, 2015, titled "Dynavax Announces Second Independent DSMB Recommendation to Continue Phase 3 Study of Heplisav-B^TM"

 

 

 

 

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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

DYNΛVAX

INNOVATING IMMUNOLOGY

 

2929 Seventh Street, Suite 100

Berkeley, CA 94710

 

 

 

 

DYNAVAX Announces Second Independent DSMB Recommendation to Continue PHASE 3 STUDY of HEPLISAV-B™

 

BERKELEY, CA – March 2, 2015 – Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine, has completed its second prespecified review and has recommended that the study continue unchanged.

 

The second DSMB review included safety data for all enrolled subjects collected through the data cut-off in February. As of the cut-off, all continuing subjects had received the second immunization (which was the last active dose for HEPLISAV-B subjects) and all had reached at least 5 months follow-up after the first immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the panel recommended continuing HBV‑23 with no change to the study.

 

One additional prespecified DSMB review will occur during the conduct of HBV-23. All study visits will be completed by October, 2015.

 

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.

 

About Dynavax

 

Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop 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

 

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This press release contains "forward-looking" statements, including expectations for the conduct and timing 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 HBV-23 can be completed as expected and 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 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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