EMERYVILLE, Calif., June 27,
2024 /PRNewswire/ -- Dynavax Technologies
Corporation (Nasdaq: DVAX), a commercial-stage
biopharmaceutical company developing and commercializing innovative
vaccines, today announced that the first participant has been dosed
in a Phase 1/2 clinical trial evaluating the safety, tolerability,
and immunogenicity of Z-1018, the company's investigational vaccine
candidate being developed for the prevention of shingles (herpes
zoster), a debilitating disease caused by the varicella-zoster
virus.
"We believe there is an opportunity to develop an improved
shingles vaccine with a significantly better tolerability profile
compared to the market-leading shingles vaccine. One of the unique
advantages of our vaccine candidate is CpG 1018 adjuvant's
established safety and tolerability profile, combined with its
ability to induce strong CD4+ T-cell responses, which are thought
to be critical in preventing the reactivation of the herpes zoster
virus," said Rob Janssen, M.D.,
Chief Medical Officer of Dynavax.
The Phase 1/2 randomized, active-controlled, dose escalation,
multicenter trial is expected to enroll approximately 440 healthy
adults aged 50 to 69 years at trial sites in Australia, and will evaluate the safety,
tolerability, and immunogenicity of Z-1018 compared to
Shingrix®. Key objectives of the trial include selecting
the optimal glycoprotein E (gE) protein dose level and dosing
schedule for further clinical development. The Phase 1/2 trial
will be used to support validation of a Patient Reported Outcome
measurement tool to differentiate Z-1018 on tolerability and to
support potential label claims. Dynavax anticipates reporting top
line immunogenicity and safety data in the second half of 2025,
including a comparison of CD4+ T-cells one month after the second
of two vaccine doses.
Shingles is an extremely painful consequence of the reactivation
of a latent varicella-zoster virus infection, the same virus that
causes childhood chickenpox, with attacks leading to potential
complications including chronic pain. While there are currently
approved vaccines for shingles, there is an unmet medical need for
a shingles vaccine with both high efficacy and improved
tolerability.
About Dynavax
Dynavax is a commercial-stage
biopharmaceutical company developing and commercializing innovative
vaccines to help protect the world against infectious diseases. The
Company has two commercial products, HEPLISAV-B® vaccine
[Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved
in the U.S., the European Union and Great
Britain for the prevention of infection caused by all known
subtypes of hepatitis B virus in adults 18 years of age and older,
and CpG 1018® adjuvant, currently used in HEPLISAV-B and
multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG
1018 as a premier vaccine adjuvant used in clinical programs for
shingles and Tdap, and in global collaborations currently focused
on adjuvanted vaccines for COVID-19, plague, seasonal influenza and
universal influenza. For more information about our marketed
products and development pipeline, visit www.dynavax.com.
Forward-Looking Statements
This press release contains
"forward-looking" statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to a
number of risks and uncertainties. All statements that are not
historical facts are forward-looking statements. Forward-looking
statements can generally be identified by the use of words such as
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"forecast," "intend," "will," "may," "plan," "project,"
"potential," "seek," "should," "think," "toward," "will," "would"
and similar expressions, or the negatives thereof, or they may use
future dates. Forward-looking statements made in this document
include statements regarding requests for future meetings with the
FDA and the potential timing or outcome of those meetings. Actual
results may differ materially from those set forth in this press
release due to the risks and uncertainties inherent in our
business, including, the availability, time and cost associated
with any potential follow up studies or additional trials,
availability and willingness of the FDA to meet, and the
uncertainty of whether these efforts will achieve our desired
results, as well as other risks detailed in the "Risk Factors"
section of our Quarterly Report on Form 10-Q for the three months
ended March 31, 2024 and periodic
filings made thereafter, as well as discussions of potential risks,
uncertainties and other important factors in our other filings with
the U.S. Securities and Exchange Commission. These forward-looking
statements are made as of the date hereof, are qualified in their
entirety by this cautionary statement and 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 www.dynavax.com is
not incorporated by reference in our current periodic reports with
the SEC.
For Investors/Media:
Paul
Cox
pcox@dynavax.com
510-665-0499
Nicole Arndt
narndt@dynavax.com
510-665-7264
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SOURCE Dynavax Technologies
