DYNAVAX TECHNOLOGIES CORPORATION
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Dynavax Technologies Corporation (Dynavax) is a public, biopharmaceutical company engaged in the manufacture, development, and distribution therapeutic products to treat and prevent allergies, infectious diseases and chronic inflammatory diseases using approaches that alter immune system responses in highly specific ways. The company was founded in August 1996 by Dr. Dennis A. Carson, Dr. Eyal Raz, and Dr. Lawrence M. Lichtenstein. Its corporate headquarters is located in Berkeley ,California.
The company discovers and develops Toll-Like Receptor 9 (TLR9), a unique receptor found on certain immune system cells. TLR9 is a versatile, property approaches that alter specific immune responses through its activation. Its clinical development pipeline include: HEPLISAV, a hepatitis B vaccine; TOLAMBA, a ragweed allergy immunotherapeutic; a hepatitis B therapy, and a cancer therapy currently being evaluated in non-Hodgkin’s lymphoma and metastatic colorectal cancer. It also has preclinical programs in influenza, hepatitis C, peanut and cat allergy, and asthma and chronic obstructive pulmonary disease.
Dynavax Technologies Corporation (Dynavax) is a biopharmaceutical company that discovers and develops products to prevent and treat infectious diseases, asthma and inflammatory and autoimmune diseases. The Company’s principal product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. Its pipeline of product candidate includes HEPLISAV; its Universal Flu vaccine; clinical-stage programs for hepatitis C and hepatitis B therapies, and preclinical programs partnered with AstraZeneca and GlaxoSmithKline (GSK). In January 2010, the Company announced the completion of the acquisition of Symphony Dynamo, Inc.
Description and history
Dynavax Technologies Corporation (Dynavax), incorporated on August 29, 1996, is a biopharmaceutical company that discovers and develops products to prevent and treat infectious diseases, asthma and inflammatory and autoimmune diseases. The Company’s principal product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. Its pipeline of product candidate includes HEPLISAV; its Universal Flu vaccine; clinical-stage programs for hepatitis C and hepatitis B therapies, and preclinical programs partnered with AstraZeneca and GlaxoSmithKline (GSK). In January 2010, the Company announced the completion of the acquisition of Symphony Dynamo, Inc.
Dynavax has worldwide rights to HEPLISAV, which is based on the Company’s immunostimulatory sequences (ISS) that specifically target TLR9 to stimulate an innate immune response. This vaccine combines the Company’s 1018 ISS with hepatitis B surface antigen (HBsAg) manufactured in its Dynavax Europe facility in Dusseldorf, Germany. In September 2009, Dynavax initiated a Phase III trial in chronic kidney disease patients and in February 2010, it initiated a Phase III lot-to-lot consistency trial in adults over 40 years of age. As of December 31, 2009, over 2,500 individuals had been vaccinated with HEPLISAV. In clinical trial conducted, PHAST (Phase III HeplisAv Short-regimen Trial), HEPLISAV met its primary endpoint. The multi-center PHAST trial evaluated more than 2,400 subjects from 11 to 55 years of age in Canada and Germany. This Phase III trial randomized subjects three to one and evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month. Results showed 95.1% of subjects, who received two doses of HEPLISAV at 0 and 1 month developed protective antibody to hepatitis B when measured at 12 weeks. Data from this trial also demonstrate that subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%. In September 2009, the United States Food and Drug Administration (FDA) removed the clinical hold on the Investigational New Drug (IND) application for individuals with chronic kidney disease.
Universal Flu Vaccine
The Company’s Universal Flu vaccine is in pre-clinical development and is designed to offer protection against influenza strains, as well reduce the dose of standard flu vaccine. The Company’s component, NP and M2e linked to its TLR9 agonist, is combined with the standard flu vaccine, which generates neutralizing antibodies.
SD-101, the Company’s hepatitis C therapy, has completed a Phase Ib clinical trial. This therapy utilizes a Type C TLR9 agonist based on its ISS. SD-101 is designed to be used in combination with therapies to reduce hepatitis C virus (HCV) viral replication and induce a long-lasting immune response.
DV-601 is the Company’s hepatitis B therapy and was in a Phase Ib clinical trial as of December 31, 2009. This treatment combines both the surface and core hepatitis B virus (HBV) antigens with an adjuvant.
As of December 31, 2009, the Company, together with AstraZeneca, was developing AZD1419, a candidate drug for asthma. AZD1419 utilizes its ISS for the treatment of allergic respiratory diseases, such as asthma.
The Company’s DV1179 is a bifunctional inhibitor of TLR7 and TLR9. Dynavax and GlaxoSmithKline have entered into an alliance to discover, develop and commercialize DV1179 and other Toll-like Receptor (TLR) inhibitors for diseases, such as lupus, psoriasis and rheumatoid arthritis.
Founded by Dr. Dennis A. Carson, Dr. Eyal Raz, and Dr. Lawrence M. Lichtenstein
Engaged in the manufacture, development, and distribution theapeutic products
RHEIN BIOTECH GMBH
ERNST & YOUNG LLP
US SIC Code
2929, Seventh Street
City province or state postal code
94710, BERKELEY, CA
Phone: +1 510 848 5100
Fax: +1 510 848 1327
Country address: UNITED STATES OF AMERICA
Website url: www.dynavax.com