<SEC-DOCUMENT>0001181431-14-034243.txt : 20141016
<SEC-HEADER>0001181431-14-034243.hdr.sgml : 20141016
<ACCEPTANCE-DATETIME>20141014161249
ACCESSION NUMBER:		0001181431-14-034243
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20141013
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20141014
DATE AS OF CHANGE:		20141014

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:		141155236

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<FILENAME>rrd417550.htm
<DESCRIPTION>8-K
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			Prepared By R.R. Donnelley Financial -- Form 8-K
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				<b>UNITED STATES </b>
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				<b>SECURITIES AND EXCHANGE COMMISSION</b>
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				<b>Washington, D.C. 20549</b>
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				<b>Form 8-K </b>
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				<b>CURRENT REPORT</b>
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				<b>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</b>
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				<b>Date of Report (Date of earliest event reported):&nbsp;&nbsp;10/13/2014 </b>
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				<b>Dynavax Technologies Corporation</b>
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				<b>(Exact name of registrant as specified in its charter)</b>
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				<b>Commission File Number:&nbsp;&nbsp;001-34207</b>
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								<b>Delaware</b>
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							&nbsp;&nbsp;
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								<b>33-0728374</b>
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								<b>(State or other jurisdiction of</b>
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								<b>(IRS Employer</b>
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								<b>incorporation)</b>
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								<b>Identification No.)</b>
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				<b>2929 Seventh Street, Suite 100</div><div Align="center">Berkeley, CA 94710-2753</b>
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				<b>(Address of principal executive offices, including zip code)</b>
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				<b>(510) 848-5100</b>
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				<b>(Registrant&#146;s telephone number, including area code)</b>
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				<b> </b>
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				<b>(Former name or former address, if changed since last report)</b>
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			<b>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:<BR><BR></b>
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			<b>[&nbsp;&nbsp;]&nbsp;&nbsp;
			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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				<b>Item 8.01.&nbsp;&nbsp;&nbsp;&nbsp;Other Events</b>
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				On October 13, 2014, we issued a press release titled "Dynavax Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
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				<b>Item 9.01.&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits</b>
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				(d) Exhibits. The following exhibit is furnished herewith: <p>99.1 Press Release, dated October 13, 2014, titled "Dynavax Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma." </div><div align="left" style="text-indent:4%">
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			<b>SIGNATURES</b>
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			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.
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							Dynavax Technologies Corporation
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							Date: October 14, 2014
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							By:
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;David Johnson</font>
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						David Johnson</font>
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						Vice President
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			<b>EXHIBIT INDEX</b>
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								<b>Exhibit&nbsp;No.</b>
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								<b>Description</b></font>
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								EX-99.1
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								Press Release, dated October 13, 2014, titled "Dynavax Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma."</font>
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<DOCUMENT>
<TYPE>EX-99
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<FILENAME>rrd417550_40895.htm
<DESCRIPTION>PRESS RELEASE, DATED OCTOBER 13, 2014, TITLED "DYNAVAX INITIATES PHASE 1/2 STUDY OF TLR-9 AGONIST IMMUNOTHERAPY IN B-CELL LYMPHOMA."
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<B><U><FONT FACE="Bodoni MT,Nyala" SIZE=7 COLOR="#808080"><P ALIGN="CENTER">D</FONT><FONT FACE="Bodoni MT,Nyala" SIZE=7 COLOR="#808080">YNAVAX</P>
</U></FONT><FONT FACE="Aparajita,Arial" SIZE=2 COLOR="#008080"><P ALIGN="CENTER">DYNAVAX TECHNOLOGIES</P>
</FONT><FONT FACE="Calibri" SIZE=2 COLOR="#008080"><P ALIGN="CENTER">2929 Seventh Street, Suite 100</P>
<P ALIGN="CENTER">Berkeley, CA 94710</P>
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<B><FONT FACE="Arial" SIZE=3><P>Contact:</B></FONT></TD>
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<FONT FACE="Arial" SIZE=3><P>Michael S. Ostrach</FONT></TD>
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<FONT FACE="Arial" SIZE=3><P>Vice President, Chief Business and Principal Financial Officer </FONT></TD>
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<FONT FACE="Arial" SIZE=3><P>510-665-7257</FONT></TD>
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<U><FONT FACE="Arial" SIZE=3 COLOR="#0000ff"><P>mostrach@dynavax.com</U></FONT></TD>
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<B><FONT FACE="Arial" SIZE=3><P ALIGN="CENTER"></P>
</FONT><FONT FACE="Arial Bold" SIZE=3><P>DYNAVAX INITIATes PHASE 1/2 STUDY of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma</P>
</FONT><FONT FACE="Arial" SIZE=3><P ALIGN="CENTER"></P>
</B><P>BERKELEY, CA - October 13, 2014 - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor (&quot;TLR&quot;) 9 agonist, in adults with untreated low-grade B-cell lymphoma. In this multicenter study (known as LYM-01), SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.</P>
<P>&quot;Beginning LYM-01 is an important milestone in the maturation of Dynavax's TLR-based cancer immunotherapy research and development efforts&quot; said Eddie Gray, Dynavax CEO. &quot;This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors.&quot;</P>
<B><P>LYM-01 Study Design</P>
</B>
<P>LYM-01 is an open-label, single arm, multicenter, dose-escalation and expansion study designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion. It will include up to 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy and are appropriate candidates for &quot;watch and wait.&quot; Treatment consists of local radiation given over 2 days followed by 5 weekly intratumoral injections of 1, 2, 4, or 8 mg of SD-101. The total duration of patient participation in this study is up to 2 years.</P>
<P>The primary objectives of LYM-01 are:</P>
<UL>
<LI>To assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation;</LI>
<LI>To evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and</LI>
<LI>To determine the maximum tolerated dose or optimal dose.</LI></UL>
<P>A key secondary objective of the study is assessment of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered. All tumor responses are assessed according to the Cheson criteria.</P>
<B><P>About SD-101</P>
</B>
<P>SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). SD-101 directly induces activation and maturation of plasmacytoid dendritic cells, leading to the production of type 1 interferons.  Preclinical and early clinical data support the use of TLR 9 agonists in patients with solid tumors and hematologic malignancies. In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies, cellular therapies, antiangiogenic agents, radiotherapy, and some chemotherapies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.</P>
<B><P>About Dynavax</P>
</B>
<P>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 </FONT><U><FONT FACE="Arial" SIZE=3 COLOR="#0000ff">www.dynavax.com</U></FONT><FONT FACE="Arial" SIZE=3>.</P>
<B><EM><P><A NAME="OLE_LINK9">Forward-Looking Statements</P>
</B></EM><P>This press release contains "forward-looking" statements, including expectations for the conduct, timing and sufficiency of LYM-01. 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 we can enroll a sufficient number of subjects into LYM-01 and ultimately complete the study and other risks detailed in the "Risk Factors" section of our current periodic reports with the&nbsp;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&nbsp;Dynavax's&nbsp;website at&nbsp;</FONT><U><FONT FACE="Arial" SIZE=3 COLOR="#0000ff">www.dynavax.com</U></FONT><FONT FACE="Arial" SIZE=3>&nbsp;is not incorporated by reference in our current periodic reports with the&nbsp;SEC.</P>
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