Dynavax Reports Final Phase 3 Data for HEPLISAV(TM) in CKD Patients and New Data
From Booster Trial in Hemodialysis Patients
BERKELEY, CA, Mar 27, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced final data from a pivotal Phase 3 trial in
patients with chronic kidney disease (CKD) demonstrating early seroprotection and
the durability of the immune response to HEPLISAV compared to Engerix-B(R). In
October 2011, Dynavax reported that the superiority endpoint had been met in this
trial. The trial included 516 patients 18-75 years of age with CKD (stage 3b or
higher) in the U.S., Canada and Germany who received 3 doses of HEPLISAV at 0, 1
and 6 months or 4 double doses of Engerix-B at 0, 1, 2 and 6 months (8 doses
total).
Analysis of the final data demonstrated that:
--HEPLISAV provided seroprotection to 90% of patients compared to 82%
for Engerix-B (P=0.01) at the primary endpoint (7 months), 1 month
after the 3rd dose of HEPLISAV and the 8th dose of Engerix-B. This
result demonstrated the previously reported superiority of HEPLISAV
seroprotection over Engerix-B.
--HEPLISAV provided seroprotection to more than twice as many patients
(heplisav:48%)(engerix-b:20%) at 2 months, 1 month after the 2nd
dose of HEPLISAV and the 4th dose of Engerix-B. This result confirmed
the earlier seroprotection of HEPLISAV in this population.
--The geometric mean concentration (GMC) of antibody, which is commonly
used to predict the duration of protection in patients with CKD, was
approximately four-fold higher in the HEPLISAV group compared to the
Engerix-B group. At Week 28, the GMC for HEPLISAV was 448 mIU/mL
compared to the Engerix-B GMC of 109 mIU/mL. At one year, six months
after completing the 3-dose regimen of HEPLISAV, the GMC was 121
mIU/mL compared to a GMC of 38 mIU/mL six months after completing the
8-dose regimen of Engerix-B.
In a separate trial, in CKD non-responder patients on hemodialysis who had failed
to develop seroprotection after two or more previous vaccination series with the
licensed vaccines, new data showed a higher seroprotection rate for HEPLISAV
compared to each of Fendrix(R) and Engerix-B.
HEPLISAV is a trademark of Dynavax, and Fendrix(R) and Engerix-B(R) are
registered trademarks of GlaxoSmithKline.
In this study of 119 patients in Germany, the immune responses were compared 4
weeks after a single booster dose of HEPLISAV or Fendrix or two booster doses of
Engerix-B. Data from this booster study showed that HEPLISAV provided
seroprotection to 44% of patients (17/39) compared to 31% (13/42) for Fendrix and
21% (8/38) for Engerix-B. Dynavax President and Chief Medical Officer, Tyler
Martin, M.D., said, "These results add to the growing body of evidence of
HEPLISAV's advantages. Patients with CKD are difficult to protect with current
HBV vaccines, requiring 8 doses of Engerix rather than 3 doses for healthy
adults. The pivotal CKD trial demonstrated the same profile as our healthy adult
trials: earlier onset of seroprotection, higher peak seroprotection and improved
duration. In addition, the results from the booster trial suggest HEPLISAV should
be the preferred vaccine in this very difficult to protect population, which
represents a substantial proportion of patients on hemodialysis."
Dynavax plans to submit a U.S. Biologics License Application (BLA) for HEPLISAV
by the middle of May for an indication in healthy adults 18-70 years of age for a
2-dose vaccination regimen at 0 and 1 month. A supplemental BLA with an
indication and 3-dose primary vaccination regimen for patients with CKD will be
filed when the initial BLA is approved.
The Advisory Committee on Immunization Practices (ACIP) and other public health
authorities recommend vaccination for all persons with end-stage renal disease,
including predialysis, hemodialysis, peritoneal dialysis and home dialysis
patients. Specific regimens or formulations are recommended for both of the
currently available hepatitis B vaccines due to the hypo-responsiveness of CKD
patients. For immunocompromised persons, including dialysis patients, it is also
recommended that additional vaccine be administered as needed to retain
seroprotective levels of antibody against hepatitis B.
There are an estimated 750,000 persons with end-stage kidney disease in the
United States and the five major European markets and an annual incidence of
150,000 new diagnoses and entry into dialysis. Dialysis patients typically
receive dialysis treatments, vaccination and monitoring of antibody levels
through a network of dialysis centers that include approximately 5,000 sites in
the United States.
About HEPLISAV HEPLISAV is an investigational adult hepatitis B vaccine. In Phase
3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses
than currently licensed vaccines. Dynavax has worldwide commercial rights to
HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary
Toll-like Receptor 9 agonist to enhance the immune response.
About Dynavax 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 designed to
provide higher and earlier protection with fewer doses than currently licensed
vaccines. For more information visit dynavax.com.
Forward-Looking Statements This press release contains "forward-looking
statements," including those relating to the potential benefits and use of
HEPLISAV, planned indications and regimens, and timing of BLA submissions, that
are subject to a number of risks and uncertainties. Actual results may differ
materially from those set forth in this press release due to the risks and
uncertainties inherent in our business, including whether successful clinical and
regulatory development and approval of HEPLISAV and our process for its
manufacture can occur in a timely manner or without significant additional
studies or difficulties or delays in development or clinical trial enrollment,
whether our studies can support registration for commercialization of HEPLISAV;
the results of clinical trials and the impact of those results on the initiation
and completion of subsequent trials and issues arising in the regulatory process,
including whether the BLA will be accepted for filing; the Company's ability to
obtain additional financing to support the development and commercialization of
HEPLISAV and its other operations, possible claims against the Company based on
the patent rights of others; and other risks detailed in the "Risk Factors"
section of our current periodic reports with the SEC. We undertake no obligation
to revise or update information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on Dynavax's
website at dynavax.com is not incorporated by reference in the
Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
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