Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics using toll-like receptor (TLR) biology. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. HEPLISAV-B The company’s main vaccine product candidate is HEPLISAV-B (previously known as HEPLISAV), an investigational adult hepatitis B vaccine in Phase 3 clinical development. HEPLISAV-B combines 1018, a proprietary TLR9 agonist adjuvant, and recombinant hepatitis B surface antigen (rHBsAg or HBsAg) manufactured at its wholly-owned subsidiary in Düsseldorf, Germany (Rhein or Dynavax Europe). In 2014, the company initiated HBV-23, a Phase 3 observer-blinded, randomized, active-controlled, multicenter trial of the safety and immunogenicity of HEPLISAV-B. Cancer Immunotherapy The company’s main cancer immunotherapy candidate is SD-101, a C Class CpG TLR9 agonist that was selected for characteristics optimal for treatment of cancer, including high interferon induction. Two Phase 1 clinical studies of SD-101 have been completed, establishing that it is safe and well-tolerated at a range of doses far exceeding the expected therapeutic level for oncology uses. Autoimmune and Inflammatory Diseases The company also has clinical and preclinical programs focused on therapeutics for autoimmune and inflammatory diseases. AZD1419 for Asthma: The company’s most advanced inflammatory disease candidate is AZD1419, which is partnered with AstraZeneca AB (AstraZeneca). AZD1419 is designed to change the basic immune response to environmental allergens, such as house dust and pollens, to prolonged reduction in asthma symptoms by converting the response from one primarily mediated by type-2 helper T cells (Th2) to type-1 helper T cells (Th1). Intellectual Property As of December 31, 2014, the company’s intellectual property portfolio included approximately 30 issued U.S. patents, 250 issued or granted foreign patents, and 50 additional pending U.S. and foreign patent applications claiming compositions and formulations of TLR agonist and inhibitors, their methods of use or processes for their manufacture. The company also has exclusive licenses under two agreements to several patents and applications owned by the Regents of the University of California. Research and Development The company’s research and development expenses included $84.6 million, as of December 31, 2014. Regulations The company and all of its contract manufacturers are required to comply with the applicable FDA or foreign regulatory agency current Good Manufacturing Practices regulations. History The company was founded in 1996. It was incorporated in California in August 1996. The company was formerly known as Double Helix Corporation and changed its name to Dynavax Technologies Corporation in September 1996. The company was reincorporated in Delaware in 2000.
dynavax technologies corp
(DVAX:Consolidated Issue listed on NASDAQ Capital Market)
2929 Seventh Street
Berkeley, CA 94710
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