Dynavax Technologies Corporation
DYNAVAX TECHNOLOGIES CORP (Form: 8-K, Received: 10/11/2011 16:06:11)
 
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):  10/07/2011
 
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 7, 2011, Dynavax Technologies Corporation ("Dynavax") issued a press release titled "Dynavax Reports Diabetic Subset Data from Modified Intent to Treat Analysis of the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40."

On October 10, 2011, Dynavax issued a press release titled "Dynavax Reports Positive Immunogenicity Data from an Analysis of Hypo-responsive Populations in HEPLISAV(TM) Phase 3 Trial."

Copies of these press releases are attached as Exhibit 99.1 and Exhibit 99.2 to this current report and are incorporated herein by reference.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits
Exhibit No.        Description
99.1        Press Release, dated October 7, 2011, titled "Dynavax Reports Diabetic Subset Data from Modified Intent to Treat Analysis of the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40."

99.2        Press Release, dated October 10, 2011, titled "Dynavax Reports Positive Immunogenicity Data from an Analysis of Hypo-responsive Populations in HEPLISAV(TM) Phase 3 Trial."

 

 

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 11, 2011
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated October 7, 2011, titled "Dynavax Reports Diabetic Subset Data from Modified Intent to Treat Analysis of the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40."
EX-99.2
  
Press Release, dated October 10, 2011, titled "Dynavax Reports Positive Immunogenicity Data from an Analysis of Hypo-responsive Populations in HEPLISAV(TM) Phase 3 Trial."

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 REPORTS DIABETIC SUBSET DATA FROM MODIFIED INTENT TO TREAT ANALYSIS OF THE HEPLISAV TM PHASE 3 TRIAL IN HEALTHY ADULTS OVER AGE 40

Berkeley, CA — October 6, 2011 — Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the results of a prospective analysis of the diabetic subset population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B ® , at all measured time points. The modified intent to treat (MITT) analysis of adults with type II diabetes showed that HEPLISAV given as 2 doses over 4 weeks protected a significantly greater proportion of subjects in a shorter time and with longer-lasting protection than Engerix-B given as 3 doses over 24 weeks. The modified intent to treat (MITT) subpopulations included all diabetic subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result.

·       Of the 218 diabetics in the MITT population (179 HEPLISAV; 39 Engerix-B), the SPRs for HEPLISAV were superior to Engerix-B at weeks 8 through 52.
 
·       At the prespecified comparison time points of week 12 for HEPLISAV and week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.
 
·       At week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B
 
·       At week 52, the SPR in the HEPLISAV group was 82% whereas the SPR in the Engerix- B group was 54% by week 52.
 

According to Tyler Martin, M.D., President and Chief Medical Officer, "The Phase 3 results we are reporting today for HEPLISAV vs. Engerix-B are the first to be obtained in a prospectively defined diabetic population. The data clearly demonstrate the superiority of HEPLISAV in diabetics and confirm our retrospective analysis reported last year. In light of the current public health discussions regarding HBV protection of this susceptible population, these results have important medical significance."

Dynavax will present additional data for the diabetic subset population at the Infectious Diseases Society of America (IDSA) on October 21, 2011.

Engerix-B® is a registered trademark of GlaxoSmithKline

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About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.

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 and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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, including the outcome of pre-filing discussions with regulatory authorities; 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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Exhibit 99.2

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 REPORTS POSITIVE IMMUNOGENICITY DATA FROM AN ANALYSIS OF HYPO-RESPONSIVE POPULATIONS IN HEPLISAV™ PHASE 3 TRIAL

Berkeley, CA — October 10, 2011 — Dynavax Technologies Corporation (NASDAQ: DVAX) today announced immunogenicity data for subpopulations known to be hypo-responsive (males, obese, and smokers) to currently licensed hepatitis B vaccines from its Phase 3 trial (HBV-16). The Phase 3 study was a multi-center, observer-blinded study to determine if the immunogenicity of two doses of HEPLISAV was non-inferior/superior to three doses of Engerix-B® by comparing seroprotection rates (SPR) at eight weeks post last dose in healthy adults over age 40.

The data demonstrate HEPLISAV’s enhanced immune response and superiority as measured by peak SPRs for the subpopulations as follows:

HEPLISAV SPR%     Engerix-B SPR%  
Adults 40 yrs.     95.1     70.5  
Males     94.6     67.8  
Females     95.6     77.8  
Obese (BMI 30 kg/m 2 )     94.7     65.4  
Non-obese     95.4     78.4  
Smokers     95.6     65.3  
Non-smokers     95.0     74.8  

As reported previously, for all safety parameters, HEPLISAV was similar to the Engerix-B control arm.

Dynavax President and Chief Medical Officer, Tyler Martin, MD, said, “These subset analyses from HBV-16 further underline the superiority of HEPLISAV compared to the current market leading HBV vaccine, Engerix-B. It has long been known that males, the obese, and smokers have an impaired response to current licensed HBV vaccines. Not only was HEPLISAV superior to Engerix-B in each of these subpopulations, the seroprotection rates in the HEPLISAV group did not decline for any hypo-responsive subset, in comparison to the responsive subset. These results substantially strengthen the observation that HEPLISAV is superior to Engerix-B.”

Dynavax will present additional detail on the hypo-responsive groups at the American Association for the Study of Liver Diseases (AASLD) later this year.

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Engerix-B® is a registered trademark of GlaxoSmithKline

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com .

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 and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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, including the outcome of pre-filing discussions with regulatory authorities; 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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