Businessweek

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. 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), and clinical-stage programs for its Universal Flu vaccine and hepatitis B therapy. HEPLISAV Hepatitis B Vaccine The company’s product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than licensed vaccines. The company has worldwide commercial rights to HEPLISAV. HEPLISAV combines its first generation 1018 immunostimulatory sequences (ISS) with hepatitis B surface antigen. In February 2012, the company announced that it had met with the U.S. Food and Drug Administration (FDA) in a Pre-Biologics License Application (pre-‘BLA’) meeting, and had agreed that the initial HEPLISAV BLA submission would be for an indication in healthy adults 18-70 years of age. HEPLISAV is designed to address the limitations of licensed vaccines by providing higher and earlier protection with fewer doses. DV1179 (Immunoregulatory Sequences (IRS)) for Autoimmune and Inflammatory Diseases The company is developing DV1179, a bifunctional inhibitor of toll-like receptor (TLR) 7 and TLR9, under a worldwide strategic alliance with GSK. Its IRS program is focused on novel TLR inhibitors for diseases, such as lupus and psoriasis. In 2011, it announced the expansion of its worldwide strategic alliance to include a new target, TLR8. The activation of TLR8 in myeloid cells yields the production of multiple pro-inflammatory cytokines, including tumor necrosis factors, IL-1, IL-6, and IL-12. In 2011, the company initiated a proof-of-mechanism clinical trial of DV1179 in systemic lupus erythematosus patients. AZD1419 Asthma Therapy The company is 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 therapy for the treatment of allergic respiratory diseases. AZD1419 is designed to change the basic immune response to environmental allergens, such as house dust and pollens. In 2011, it agreed to advance AZD1419 into preclinical toxicology studies. Universal Flu Vaccine The company’s Universal Flu vaccine is designed to offer protection against divergent influenza strains, as well as to increase the efficacy and potentially reduce the antigen content of standard flu vaccines. DV-601 Hepatitis B Therapy DV-601, the company’s proprietary hepatitis B therapy, completed a Phase 1b clinical trial and is part of its portfolio of development programs that are available for partnership. Its treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX adjuvant. DV-601 is designed to induce an immune response against HBV-infected cells. Intellectual Property As of December 31, 2011, the company’s intellectual property portfolio included 18 issued U.S. patents, approximately 100 issued or granted foreign patents, and approximately 100 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. It has an issued U.S. patent covering the ISS contained in its HEPLISAV investigational vaccine that would expire in 2018, unless extended, and corresponding issued patents in various major European and other countries. Regulatory Considerations The company and all of its contract manufacturers are required to comply with the applicable FDA current Good Manufacturing Practice regulations. Research and Development The company’s research and development expenses were $51.3 million for the year ended December 31, 2011. Competition The company’s hepatitis B therapy faces competition from various companies developing antivirals and immunomodulators, including GSK, Achillon, Bukwang, and Chongqing Jiachen Biotech. 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.