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):  December 4, 2014

 

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 1.01.    Entry into a Material Definitive Agreement

 

On December 4, 2014, Dynavax Technologies Corporation ("Dynavax") entered into Amendment No. 6 to the Research Collaboration and License Agreement dated September 1, 2006 by and between the Company and AstraZeneca AB ("AstraZeneca"), dated as of December 8, 2014 (the "Amendment"), pursuant to which Dynavax will conduct and AstraZeneca will fully fund a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma.  

 

The foregoing summary is not complete and is qualified in its entirety by reference to the Amendment, which will be filed with the Dynavax Annual Report on Form 10-K for the year ended December 31, 2014.

 

On December 8, 2014, Dynavax issued a press release announcing the Amendment. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

 

Item 9.01.    Financial Statements and Exhibits

 

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

99.1 Press Release, dated December 8, 2014, titled "Dynavax and AstraZeneca to Advance TLR9 Agonist for Treatment of Asthma into Phase 2a Clinical Study”

 

 


 


 

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:

December 8, 2014

By:

/s/  David Johnson

 

 

 

David Johnson

 

 

 

Vice President

 


 


 

EXHIBIT INDEX

 

 

Exhibit No.

 

Description

EX-99.1

 

Press Release, dated December 8, 2014, titled "Dynavax and AstraZeneca to Advance TLR9 Agonist for Treatment of Asthma into Phase 2a Clinical Study”

 

 



Exhibit 99.1

 

DYNAVAX

DYNAVAX TECHNOLOGIES

2929 Seventh Street, Suite 100

Berkeley, CA 94710

 

Contact:

 

 

Michael Ostrach

 

 

Chief Business and Principal Financial Officer

 

 

510-665-7257

 

 

mostrach@dynavax.com

 

 

 

 

DYNAVAX and astrazeneca To Advance TLR9 AGONIST FOR TREATMENT OF ASTHMA INTO PHASE 2A CLINICAL STUDY

 

BERKELEY, CA – December 8, 2014 – Dynavax Technologies Corp. (NASDAQ: DVAX) today announced that the Company and AstraZeneca AB (“AstraZeneca”) signed an amendment to the existing Research Collaboration and License Agreement under which AstraZeneca will fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma.  

 

AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use.  The decision to accelerate this potential disease-modifying therapeutic into Phase 2, eliminating the previously planned Phase 1b study, was based on the positive results of a Phase 1a study in 45 healthy volunteers. The primary study objective was assessment of the safety of 4 weekly doses of AZD1419 or placebo. Ascending doses were well tolerated with no serious adverse events observed in treated subjects. Additional endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells.

 

Dynavax intends to initiate the Phase 2a study in asthma patients in the first half of 2015 and a milestone is payable on its initiation.  Remaining potential milestone payments to Dynavax total approximately $100 million. In addition, Dynavax will receive royalties on worldwide sales of any approved products resulting from the collaboration and will have the opportunity to co-promote in the United States.

 

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.

 

About AstraZeneca

 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.


 

 

Forward Looking Statements

This press release contains "forward-looking statements," including statements related to expected payments under our AstraZeneca agreement and the expected initiation of a Phase 2a trial. 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 study will receive timely regulatory approval to proceed or results of completed studies can be replicated in further studies as well as difficulties or delays in discovery or development, initiation and completion of studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our AstraZeneca agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed 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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