Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, develops products to prevent and treat infectious and inflammatory diseases and cancer based on Toll-like Receptor (TLR) biology and its ability to modulate the innate immune system. The company’s product candidates include both TLR agonists and TLR inhibitors. Its clinical stage programs include its autoimmune program partnered with GlaxoSmithKline (GSK), its asthma therapeutic program partnered with AstraZeneca AB (AstraZeneca), and its cancer immunotherapy program. The company is also advancing preclinical development programs in adjuvant technology and TLR 7, 8, and 9 inhibition. Development Programs The company’s pipeline of product candidates includes the following: HEPLISAV-B Hepatitis B Vaccine The company’s primary product candidate is HEPLISAV-B, an investigational adult hepatitis B vaccine in Phase 3 clinical development. HEPLISAV-B combines its proprietary TLR 9 agonist adjuvant and hepatitis B surface antigen to elicit an immune response after two doses. In Phase 3 trials, HEPLISAV-B demonstrated higher and earlier protection with fewer doses than currently-licensed vaccines. The company has worldwide commercial rights to HEPLISAV-B. In 2013, the company received a complete response letter from the U.S. Food and Drug Administration (FDA) indicating that it would not approve HEPLISAV-B for the indication proposed in its biologics license application (BLA). In 2014, the company expected to initiate a Phase 3 study of HEPLISAV-B compared with Engerix-B in adults 18-70 years of age to provide a sufficiently-sized safety database for the FDA to complete its review of the company’s BLA. DV1179 TLR Inhibitor for Autoimmune and Inflammatory Diseases DV1179 is a novel inhibitor of TLR 7 and TLR 9 that is being evaluated as a therapeutic for autoimmune and inflammatory diseases, under a worldwide strategic alliance with GSK. The company initiated a proof-of-mechanism clinical trial of DV1179 in systemic lupus erythematosus patients. TLR 7 and TLR 9 have been implicated in the chronic inflammatory response in this disease. GSK has an option to obtain a license to this program following completion of this trial expected in 2014. AZD1419 TLR Agonist for Asthma Therapy The company is developing AZD1419, a novel candidate drug for asthma, under its collaboration agreement with AstraZeneca. AZD1419 is a proprietary second-generation TLR agonist and represents a new disease-modifying approach to the treatment of allergic respiratory diseases. AZD1419 is designed to change the basic immune response to environmental allergens, such as house dust and pollens, leading to prolonged reduction in asthma symptoms by converting the response from one primarily mediated by type-2 helper T cells to type-1 helper T cells. In 2013, the company initiated dosing in a Phase 1 study to assess the safety of AZD1419. SD-101 for Immunotherapy of Cancer SD-101 is a proprietary second-generation TLR 9 agonist that is designed to stimulate a specific immune response, including potent interferon-alpha induction. This product candidate has been evaluated in two phase 1 studies to assess its safety and tolerability and is being tested in an investigator-sponsored study in patients with relapsed lymphoma after allogeneic bone marrow transplant. DV230 Adjuvant Technology The company has developed a new adjuvant platform, DV230, with funding received from the National Institute of Allergy and Infectious Diseases. Oligonucleotide TLR 9 agonists are activators of innate immunity and adjuvants. Intellectual Property As of December 31, 2013, the company’s intellectual property portfolio included 28 issued U.S. patents, approximately 200 issued or granted foreign patents, and approximately 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 various patents and applications owned by the Regents of the University of California. The company has an issued U.S. patent covering the TLR agonist contained in its HEPLISAV-B investigational vaccine that would expire in 2018, and has correspondingly issued patents in various major European and other countries. It owns or has an exclusive license to the U.S. and foreign patent applications pending for each of its other product candidates and/or their uses. Regulation 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. Research and Development The company’s research and development expenses were $50.9 million for the year ended December 31, 2013. 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
2929 Seventh Street
Berkeley, CA 94710
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