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Dynavax
Technologies (DVAX)

Website:
www.Dynavax.com
"Developing
Products To Help The Immune System Prevent And Control Disease"
Overview
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.
DVAX
Investor Highlights
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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.
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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.
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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
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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:
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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.
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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.
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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.
Three
Month Chart

SEC Filings
DVAX filings with the SEC can be
found here.
Contacts
Dynavax Technologies
2929 Seventh
Street
Suite 100
Berkeley, CA 94710-2753
Phone: 510-848-5100
Fax: 510-848-1327
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