-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Cbq3WEdhA5v7qb3cjOe/9Iptp1/UkZMX2esn/0uifcPSOzBPNaYemzkCF5D36u23 NxranbA3aM230ov9qN39/A== 0001181431-10-049158.txt : 20101004 0001181431-10-049158.hdr.sgml : 20101004 20101004141653 ACCESSION NUMBER: 0001181431-10-049158 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101004 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101004 DATE AS OF CHANGE: 20101004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYNAVAX TECHNOLOGIES CORP CENTRAL INDEX KEY: 0001029142 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330728374 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34207 FILM NUMBER: 101105104 BUSINESS ADDRESS: STREET 1: 2929 SEVENTH STREET STREET 2: SUITE 100 CITY: BERKELEY STATE: CA ZIP: 94710 BUSINESS PHONE: 5108485100 MAIL ADDRESS: STREET 1: 2929 SEVENTH STREET STREET 2: SUITE 100 CITY: BERKELEY STATE: CA ZIP: 94710 8-K 1 rrd287868.htm 8-K Prepared By R.R. Donnelley Financial -- Form 8-K
 
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):  10/04/2010
 
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
  
(IRS Employer
incorporation)
  
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 October 4, 2010, Dynavax Technologies Corporation (Dynavax) issued a press release titled "Dynavax's HEPLISAV(TM) Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-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) Exhibit
Exhibit No.        Description
99.1        Press Release, dated October 4, 2010, titled "Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B."
 

 

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.
 
           
Dynavax Technologies Corporation
 
 
Date: October 04, 2010
     
By:
 
/s/    Michael S. Ostrach
               
Michael S. Ostrach
               
Vice President
 
 

 

EXHIBIT INDEX
 
Exhibit No.
  
Description
EX-99.1
  
Press Release, dated October 4, 2010, titled "Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B."
EX-99.1 2 rrd287868_33035.htm PRESS RELEASE, DATED OCTOBER 4, 2010, TITLED "DYNAVAX'S HEPLISAV DEMONSTRATES SUPERIOR SEROPROTECTION IN DIABETICS COMPARED TO ENGERIX-B."

Exhibit 99.1

DYNAVAX

DYNAVAX TECHNOLOGIES

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 HEPLISAV DEMONSTRATES SUPERIOR SEROPROTECTION IN DIABETICS COMPARED TO ENGERIX-B

Late-Breaker AASLD Abstract and New Diabetic Data Published Online

Berkeley, CA - October 4, 2010 - In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation (NASDAQ: DVAX) reported that its novel hepatitis B vaccine candidate, HEPLISAV™, given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV™ Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B®) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.

According to Dr. Tyler Martin, President and Chief Medical Officer of Dynavax, "Diabetics are at risk for hepatitis B infection, and once infected, their disease frequently results in more severe chronic illness. The situation is complicated by the fact that patients with diabetes commonly do not respond well to currently licensed hepatitis B vaccines. The data we will report at the AASLD meeting is particularly exciting as our technology clearly represents a potential breakthrough in immunization regimens as well as a means of significantly expanding the number of individuals for whom protection against hepatitis B will be possible.

"It is well known that epidemic outbreaks of hepatitis B have occurred over the last several years in long-term care facilities. However, vaccination against the disease has been limited because patients in this setting simply do not respond to vaccination as well as healthy, younger adults in the general population. The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the issue for quite some time, and later this month will consider a new recommendation for hepatitis B vaccination of adults with diabetes," Dr. Martin continued.

-more-

Engerix-B® is a registered trademark of GlaxoSmithKline

Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating non-inferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.

 

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.

Forward Looking Statements

This press release contains "forward-looking statements," including the potential for use of HEPLISAV 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 the reported results can be replicated in prospective studies, 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 C ompany 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.

# # #

 -----END PRIVACY-ENHANCED MESSAGE-----