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):   January 18, 2016

 

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))

 

 

 

 

 

 

---

Item 1.01.    Entry into a Material Definitive Agreement

On January 18, 2016, Dynavax Technologies Corporation ("Dynavax") entered into Amendment No. 7 to the Research Collaboration and License Agreement dated September 1, 2006 by and between Dynavax and AstraZeneca AB ("AstraZeneca"), effective as of January 13, 2016 (the "Amendment"), pursuant to which AstraZeneca will now conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma, that was originally to be conducted by Dynavax.  

 

The foregoing summary is not complete and is qualified in its entirety by reference to the Amendment, which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2016.

 

On January 19, 2016, 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.

99.1 Press Release, dated January 19, 2016, titled "Dynavax and AstraZeneca Amend their Agreement for Asthma Drug Candidate"

 

 

 

---

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.

 

 

 

 

---

EXHIBIT INDEX

 

 

 

Exhibit 99.1

 

DYNΛVAX

INNOVATING IMMUNOLOGY

2929 Seventh Street, Suite 100

Berkeley, CA 94710

 

 

DYNAVAX and astrazeneca Amend their agreement for Asthma Drug Candidate

AstraZeneca to conduct Phase 2a clinical study of AZD1419

 

BERKELEY, CA – 1/19/16 – Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Company and AstraZeneca signed an amendment to their existing Research Collaboration and License Agreement under which, based on the strategic priorities of the two companies, AstraZeneca will now conduct a Phase 2a safety and efficacy trial of AZD1419 in asthma patients that was originally to be conducted by Dynavax.  

In a previously reported Phase 1a study of the safety of 4 weekly doses of AZD1419 compared to placebo in 45 healthy volunteers, 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.

On the basis of these encouraging results, the companies decided to bypass a planned Phase 1b trial and proceed to Phase 2a, a study that was to be conducted by Dynavax. As trial design progressed, AstraZeneca elected, with Dynavax’s full support, to conduct the study in house, consistent with AstraZeneca’s commitment to respiratory disease, one of the company’s three main therapy areas, and Dynavax’s increasing strategic focus on vaccines and immuno-oncology.

"Our partnership with AstraZeneca is focused on the advancement of AZD1419. This amendment will promote that objective by leveraging AstraZeneca’s expertise in international clinical development of respiratory products," said Eddie Gray, Chief Executive Officer of Dynavax.

AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The Phase 2a study is planned to be initiated in 2016.  For more information on this project, visit www.astrazeneca.com/what-science-can-do/tlr-9.html#.

 

---

 

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B™, a Phase 3 investigational adult hepatitis B vaccine and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. 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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience.  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 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.

Contact:

Michael Ostrach

Chief Financial Officer

510-665-7257

mostrach@dynavax.com