Dynavax Technologies (DVAX)

Website: www.Dynavax.com

"Developing Products To Help The Immune System Prevent And Control Disease"  

Dynavax Technologies (DVAX) is a clinical-stage biopharmaceutical company, that discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines.

• Announced data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

• Announced the addition of two new senior executives to direct key commercial and clinical activities prior to the launch of HEPLISAV(TM), an investigational adult hepatitis B vaccine.

• Announced that its GMP manufacturing facility in Dusseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of HEPLISAV, the Company's investigational adult hepatitis B vaccine

• Announced that enrollment has been completed for the first of three cohorts of patients receiving DV-601 hepatitis B therapy in a Phase 1b clinical trial.

Recent News and Press Releases

Dynavax Selects Clinical Candidate in Universal Flu Vaccine Program

Dynavax and GlaxoSmithKline Select Clinical Candidate in the Endosomal TLR Inhibitor Program

Dynavax Receives Canadian Approval to Conduct Phase 3 Trials of HEPLISAV(TM)

Dynavax Initiates Large-Scale Phase 3 Trial of HEPLISAV(TM)

Dynavax Reports Positive Phase 1b Data for SD-101 in Chronic Hepatitis C Infection

Dynavax Expands Commercial and Clinical Leadership

Dynavax Completes Symphony Dynamo Acquisition

Dynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen

Dynavax Completes Enrollment of First Cohort of Patients in Phase 1b Clinical Trial for Hepatitis B Therapy

For the latest Quote and News on DVAX Click Here.

Pipeline

HEPLISAV Hepatitis B vaccine

The lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine that is designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. Our global strategy is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.

DVAX has initiated a Phase 3 trial in chronic kidney disease patients and expects to begin a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 (TLR9) agonist to enhance the immune response.

Clinical Results

Over 2,500 individuals have been vaccinated with HEPLISAV to date. Phase 3 Data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months.

Commercial Opportunity

The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.

Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination.  In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the 5 major European markets and approximately 150,000 new patients are added annually.  Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and 20% require boosters.  As vaccination for these patients occurs regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.

Hepatitis C

DVAX's Hepatitis C therapy has demonstrated safety and reproducible antiviral activity in a Phase 1b trial.  SD-101 hepatitis C therapy utilizes a novel second-generation Toll-like Receptor 9 (TLR9) agonist and may offer a more effective therapeutic option for patients chronically infected with the hepatitis C virus (HCV).

Development of SD-101 was funded through Symphony Dynamo, Inc. (SDI) agreement, and DVAX recently excersided its option to acquire SDI, including approximately $20 million in cash and all rights to its hepatitis C and cancer therapy programs.

Commercial Opportunity

According to the World Health Organization, there are 170 million people worldwide chronically infected with HCV.  We estimate the current worldwide market for HCV therapeutics is over $3.5 billion annually. 

While there is no vaccine available to prevent HCV, current therapy includes pegylated interferon alpha and the antiviral drug ribavirin.  Both of these therapies may cause significant side effects and are only effective in treating half of all patients infected with HCV.

The HCV therapy is designed to be used in combination with oral antiviral therapy to stop HCV viral replication and induce a long-lasting T-cell immune response.

Hepatitis B Therapy

DVAX's hepatitis B therapy, DV-601, is currently in phase 1b clinical development. This novel treatment approach, which for the first time combines both the surface and core hepatitis B virus (HBV) antigens, may offer a more effective therapeutic option for patients chronically infected with HBV.  We have retained all commercial rights to this product.

Commercial Opportunity

Over 350 million individuals worldwide are chronically infected with HBV, which can lead to cirrhosis of the liver and liver cancer. The current worldwide market for HBV therapeutics is estimated to be over $1 billion annually and available therapies have modest efficacy.

The HBV therapy, used in combination with existing antiviral therapies, is expected to induce a potent immune response against HBV-infected cells in the liver to eradicate HBV infection and may offer a more effective therapeutic option for chronically infected patients.

Asthma Therapy

Together with its partner AstraZeneca, DVAX is developing AZD1419, a novel candidate drug for asthma. DVAX's asthma therapy utilizes a second-generation Toll-like Receptor 9 agonist and represents a new strategy for the treatment of allergic respiratory diseases such as asthma. This therapy is designed to modify the course of these diseases by changing the basic immune response to environmental allergens, such as house dust and pollens, leading to prolonged reduction in asthma symptoms.

DVAX is developing ADZ1419 under its worldwide collaboration with AstaZeneca to discover, develop, and commercialize products for asthma and COPD. We are currently working on a second candidate drug and have extended our research collaboration with AstraZeneca to provide research funding for a third candidate.

Commercial Opportunity

According to the World Health Organization, asthma affects 300 million people worldwide. Asthma is a chronic disease of the lungs and is caused primarily by allergic inflammation of the airways. In addition, 210 million people worldwide are affected by COPD, a term used to describe chronic lung diseases that limit airflow in the lungs. Analysts estimate the current worldwide market opportunity for asthma and COPD therapies to be over $15 billion annually.

Current asthma and COPD therapies include corticosteroids and bronchodilators, which treat the symptoms of these respiratory diseases. AZD1419 is intended to be a disease modifying therapy that has demonstrated the potential to inhibit and induce durable changes to the allergic response that causes asthma symptoms.

Autoimmunity / Inflammation

Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its first-in-class oligonucleotide-based Toll-like Receptor (TLR) inhibitors, called immunoregulatory sequences (IRS).  TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.  Dynavax’s lead inhibitor drug candidate is DV1079, a bifunctional inhibitor of TLR7 and TLR9.

Dynavax and GlaxoSmithKline have entered into a worldwide strategic alliance  to discover, develop, and commercialize novel TLR inhibitors for diseases such as lupus, psoriasis, and rheumatoid arthritis.  We will conduct research and early clinical development in up to four programs and are eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program.  GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances.  After exercising its option, GSK will carry out further development and commercialization of these products.  We will receive tiered, up to double-digit royalties on sales and have retained an option to co-develop and co-promote one product.

Commercial Opportunity

Over 20 million individuals in the U.S. and Europe have autoimmune diseases such as lupus, psoriasis, and rheumatoid arthritis.  Key biologic drugs used to treat these conditions generate over $15 billion in worldwide sales each year. 

DVAX's TLR inhibitors have demonstrated a highly targeted effect on key immune cells and pathways that play a role in multiple autoimmune and inflammatory diseases. In contrast, currently marketed and pipeline products are broadly immunosuppressive with variable efficacy and substantial toxicity.

Flu Vaccine

DVAX's novel Universal Flu vaccine is in preclinical development and is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine.  This unique approach is based on combining two highly conserved antigens and our proprietary second-generation Toll-like Receptor 9 (TLR9) agonist with standard flu vaccines:

• Two highly conserved antigens NP and M2e offer protection against divergent strains - Our Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains.  NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix 2 protein, is conserved but with some variations among species.  NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains.

• Our proprietary second-generation TLR9 agonist to enhance efficacy and enable dose-sparing - NP and M2e are linked to our proprietary second-generation TLR9 agonist, which has demonstrated the potential to boost the immune response and enable dose sparing, which could extend the quantity of standard flu vaccine available.

• Standard flu vaccine - Our proprietary component, NP and M2e linked to our TLR9 agonist, is combined with the standard flu vaccine, which provides neutralizing antibodies.  Our proprietary component could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV) and emerging strains such as H5N1 or H1N1.

DVAX research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has established a worldwide supply and option agreement with Novartis Vaccines and Diagnostics, Inc. for our Universal Flu vaccine program.

Commercial Opportunity

Human viral influenza is an acute respiratory disease with high morbidity and mortality that occurs in annual epidemics worldwide. There are an estimated 30,000 to 40,000 viral influenza-associated deaths per year in the United States, primarily in those over 65 years of age. Influenza pandemics occur infrequently, on average every 30 to 40 years, but the next pandemic could result in millions of deaths worldwide. Analysts estimate the current worldwide market opportunity for seasonal influenza vaccines to be approximately $3 billion annually.

Standard flu vaccines can provide protection against the influenza strains predicted to be prevalent during a season. The efficacy of these vaccines is often decreased by unpredictable changes in the actual strains causing influenza. Current vaccines are also least effective in those who need prevention the most, the elderly and others with weaker immune systems. Pandemic vaccination is further complicated by the need to produce large quantities of vaccine in a short time period.

DVAX's Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.

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Contacts

Dynavax Technologies

2929 Seventh Street 
Suite 100
Berkeley, CA 94710-2753
Phone: 510-848-5100
Fax: 510-848-1327

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