Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The company’s lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. As of February 25, 2013, Dynavax announced that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV. In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. Product Candidates The company’s pipeline of product candidates includes: HEPLISAV, its autoimmune program partnered with GlaxoSmithKline (GSK) and its therapy for asthma partnered with AstraZeneca AB (AstraZeneca). Its product candidates are based on its proprietary technology which uses immunostimulatory and immunoregulatory sequences. Development Programs The company’s pipeline of product candidates includes the following: HEPLISAV Hepatitis B Vaccine: HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines its first generation ISS, 1018, (1018 ISS) with hepatitis B surface antigen (HBsAg) manufactured in its Dynavax facility in Düsseldorf, Germany. As of February 25, 2013, the company announced that it had received a CRL from the FDA regarding its BLA for HEPLISAV. DV1179 (IRS) for Autoimmune and Inflammatory Diseases: The company’s IRS program is focused on novel inhibitors of TLR7, TLR8 and TLR9 for autoimmune and inflammatory diseases, under a worldwide strategic alliance with GlaxoSmithKline (GSK). In 2011, the company initiated a proof-of-mechanism clinical trial of DV1179, a bifunctional inhibitor of TLR7 and TLR9, in systemic lupus erythematosus patients. The company also is in the process of developing inhibitors of TLR8 for the treatment of multiple autoimmune and inflammatory diseases in this collaboration. The activation of TLR8 in myeloid cells yields the production of multiple pro-inflammatory cytokines including tumor necrosis factors, Interleukin-1, Interleukin-6 and Interleukin-12. AZD1419 Asthma Therapy: The company is in the process of developing AZD1419, a novel candidate drug for asthma, under its collaboration agreement with AstraZeneca. AZD1419 utilizes its proprietary second-generation ISS and represents a new 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, to prolonged reduction in asthma symptoms. Pharmaceutical Partnerships GlaxoSmithKline: In 2008, the company entered into a worldwide strategic alliance with GSK to discover, develop, and commercialize TLR inhibitors. GSK can exercise its exclusive option to license each program upon achievement of certain events and the company is eligible to receive contingent option exercise payments. AstraZeneca AB: In 2006, the company entered into a three-year research collaboration and license agreement with AstraZeneca for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease. In 2011, the company amended its agreement with AstraZeneca to provide that the company would conduct initial clinical development of AZD1419. National Institutes of Health: In 2008, the company was awarded a contract to develop its advanced ISS technology using TLR9 agonists as vaccine adjuvants. This five-year contract was awarded by the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and supports adjuvant development for biodefense vaccines, including anthrax as well as other diseases. Intellectual Property As of December 31, 2012, the company’s intellectual property portfolio included 25 issued U.S. patents, approximately 150 issued or granted foreign patents and 50 additional pending U.S. and foreign patent applications claiming compositions and formulations of ISS and IRS, 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. The company has an issued U.S. patent covering the Immunostimulatory Sequences contained in its HEPLISAV investigational vaccine that would expire in 2018, unless extended, and corresponding issued patents in several major European and other countries. The company owns or has a license to U.S. and foreign patent applications pending for each of its other product candidates and/or their uses. Research and Development The company’s research and development expenses were $49.1 million, as of December 31, 2012. Significant Events In March 2014, Dynavax Technologies Corp. and AstraZeneca amended their research collaboration and license agreement to transfer responsibility for conduct of further clinical trials from Dynavax to AstraZeneca, following completion of the ongoing Phase 1 clinical study of AZD1419 for the treatment of asthma. History Dynavax Technologies Corporation was founded in 1996. The company was incorporated in California in August 1996 under the name Double Helix Corporation. It 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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