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dynavax technologies corp (DYF) 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 (DYF) 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 (DYF) Key Developments

Dynavax Technologies Corporation Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma

Dynavax Technologies Corporation announced initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor (TLR) 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. LYM-01 Study Design: 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 "watch and wait." 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. The primary objectives of LYM-01 are: To assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation; to evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and to determine the maximum tolerated dose or optimal dose. 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.

Dynavax Technologies Corporation Announces Resignation of Dino Dina, M.D, from the Board of Directors

Dynavax Technologies Corporation announced that Dino Dina, M.D, has resigned from the Board of Directors. Dr. Dina was a director of the company since 1997 and was the company's Chief Executive Officer between 1998 and 2013.

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.


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