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dynavax technologies corp (DVAX) Details

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops products to prevent and treat infectious and inflammatory diseases, and cancer. It develops product candidates based on the use of immunostimulatory sequences and immunoregulatory sequences. Its lead product candidate is HEPLISAV, a investigational adult hepatitis B vaccine which is in Phase III clinical trials. The company also develops DV1179, a TLR inhibitor of TLR 7 and TLR9 for the treatment of autoimmune and inflammatory diseases that is in Phase I clinical trials; AZD1419, a candidate drug for the treatment of asthma, which is in Phase I clinical trials; SD-101, a second-generation TLR 9 agonist for immunotherapy of cancer that is in Phase I clinical trials; and DV230, an adjuvant platform that is in preclinical studies. It has a strategic alliance with GlaxoSmithKline to discover, develop, and commercialize TLR inhibitors; and a research collaboration and license agreement with AstraZeneca AB for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease. The company was formerly known as Double Helix Corporation and changed its name to Dynavax Technologies Corporation in September 1996. Dynavax Technologies Corporation was founded in 1996 and is based in Berkeley, California.

151 Employees
Last Reported Date: 03/10/14
Founded in 1996

dynavax technologies corp (DVAX) Top Compensated Officers

Chief Executive Officer and Director
Total Annual Compensation: $533.3K
Principal Financial Officer, Chief Business O...
Total Annual Compensation: $342.2K
Senior Vice President of Operations and Quali...
Total Annual Compensation: $305.8K
Chief Medical Officer and Vice President of C...
Total Annual Compensation: $323.9K
Chief Scientific Officer and Vice President
Total Annual Compensation: $282.6K
Compensation as of Fiscal Year 2013.

dynavax technologies corp (DVAX) Key Developments

Dynavax Technologies Corporation Completes Enrollment of Phase 3 Study of HEPLISAV-B

Dynavax Technologies Corporation announced completion of planned enrollment in the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. More than 8,250 adults, including over 1,100 diabetic subjects, have been enrolled at 40 sites in the U.S. This large safety and immunogenicity study (known as HBV-23) is intended to provide an adequately-sized database of vaccinated subjects to enable the U.S. Food and Drug Administration to complete its review of the pending HEPLISAV-B Biologics License Application. The study is also designed to assess the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus. HBV-23 is an observer-blinded, randomized, active-controlled trial. Adult subjects between the ages of 18 and 70 have been randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B(R). Safety follow up will continue for 12 months following each subject's second vaccination. All study visits will be completed by October, 2015.

Dynavax Technologies Corporation Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014

Dynavax Technologies Corporation announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total revenues of $3,048,000 compared with $3,392,000 for the same period a year ago. Loss from operations was $24,854,000 compared with $17,049,000 for the same period a year ago. Net loss was $24,777,000 or $0.09 per basic and diluted share compared with $17,164,000 or $0.09 per basic and diluted share for the same period a year ago. For the six months, the company reported total revenues of $6,546,000 compared with $5,477,000 for the same period a year ago. Loss from operations was $38,821,000 compared with $37,928,000 for the same period a year ago. Net loss was $38,617,000 or $0.15 per basic and diluted share compared with $37,989,000 or $0.21 per basic and diluted share for the same period a year ago.

Dynavax Technologies Corporation Reports Pharmacodynamic Results for Asthma and Lupus Drug Candidates

Dynavax Technologies Corporation reported pharmacodynamic and safety results from clinical studies of its asthma drug candidate partnered with AstraZeneca and its systemic lupus erythematosus (SLE) drug candidate partnered with GlaxoSmithKline. In April 2014, Dynavax initiated HBV-23, a large safety and immunogenicity study of its investigational adult hepatitis B vaccine. The study was designed to provide a sufficiently-sized safety database for the U.S. Food and Drug Administration to complete its review of the HEPLISAV-B Biologics License Application. It is being conducted at 40 sites in the U.S. and will include approximately 8,250 subjects. Dynavax expects that all HBV-23 study subjects will be enrolled by the end of 2014 and all follow-up visits will be completed by the fourth quarter of 2015. In a Phase 1 study, 4 weekly doses of a TLR9 agonist, AZD1419, or placebo were delivered by inhalation to 45 healthy volunteers. Ascending doses up to 15.4 mg/week for 4 weeks were well tolerated and no serious adverse events were observed in treated subjects. Secondary endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells. Based on these results, Dynavax and its collaboration partner, AstraZeneca, are evaluating protocols for a clinical trial in patients with asthma. In a Phase 1b/2a study, the safety and pharmacodynamics of a bifunctional TLR7 and TLR9 inhibitor, DV1179, were assessed in 52 SLE patients screened for elevated expression of interferon-regulated genes. DV1179 did not meet the primary or secondary pharmacodynamic endpoints related to reduction in interferon alpha-regulated genes. Doses up to 60 mg/week for 8 weeks were well tolerated. The most common adverse events were injection site reactions. GlaxoSmithKline will review the data package and determine whether to exercise its option to license DV1179.


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