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): 5/27/2010
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
Commission File Number: 001-34207
| Delaware | 33-0728374 | |
| (State or other jurisdiction of incorporation) |
(IRS Employer Identification No.) |
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)) |
| Item 8.01 | Other Events |
On May 27, 2010, Dynavax Technologies Corporation (Dynavax) issued a press release titled “Dynavax’s Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations - Second Safety Assessment Complete.” 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) Exhibit
| Exhibit |
Description | |
| 99.1 | Press Release, dated May 27, 2010, titled “Dynavax’s Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations - Second Safety Assessment Complete.” | |
Signature(s)
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.
| DYNAVAX TECHNOLOGIES CORPORATION | ||||||
| Date: May 27, 2010 | By: | /s/ MICHAEL S. OSTRACH | ||||
| Michael S. Ostrach Vice President | ||||||
Exhibit 99.1
| ||||
|
2929 Seventh Street, Suite 100 Berkeley, CA 94710 |
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
mostrach@dynavax.com
DYNAVAX’S TWO PHASE 3 HEPLISAV TRIALS CLEARED BY DSMB
TO CONTINUE IMMUNIZATIONS
Second Safety Assessment Complete
Berkeley, CA – May 27, 2010 – Dynavax Technologies Corporation (Nasdaq: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax’s two ongoing Phase 3 trials for HEPLISAVTM has completed the second of its planned safety assessments. The evaluation included data from 2,264 subjects that received their first injection, 1,611 of whom received their first and second injections. The DSMB determined that the studies may continue without modification.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company’s lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
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Forward Looking Statements
This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties. 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 successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company’s ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company’s current periodic reports with the SEC.
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