EMERYVILLE, Calif., May 14, 2024
/PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq:
DVAX) today provided a regulatory update for the Company's
supplemental Biologics License Application (sBLA) to include a
four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant),
Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and
Drug Administration (FDA) has issued a Complete Response Letter
(CRL) in response to the sBLA, stating that the application did not
provide sufficient data to support the full evaluation of
effectiveness or safety of a four-dose regimen of HEPLISAV-B. The
CRL has no impact on the approved indication for HEPLISAV-B in the
U.S., the European Union, and Great
Britain, which is for the prevention of infection caused by
all known subtypes of hepatitis B virus in adults 18 years of age
and older. The CRL also does not affect the approval decision
received from the European Commission in October 2023 for the four-dose
HEPLISAV-B regimen for the adult hemodialysis population.
The sBLA was comprised of clinical immunogenicity and safety
data from the Phase 1 HBV-24 study of a four-dose regimen of
HEPLISAV-B in 119 adults undergoing hemodialysis, as well as five
supportive clinical trials of HEPLISAV-B in adults with chronic
kidney disease or undergoing hemodialysis. The CRL stated that the
data from HBV-24 were insufficient due to the destruction of data
source documents by a third-party clinical trial site operator for
approximately half of the subjects enrolled in the trial. In
addition, the total number of subjects in the single-arm HBV-24
study was deemed to be insufficient to evaluate safety of the
four-dose regimen.
"We remain confident in the data generated to support HEPLISAV-B
vaccination for adult hemodialysis patients. All key data collected
in HBV-24 were verified against original source documents during
the conduct of the trial," said Rob Janssen, M.D., Chief
Medical Officer of Dynavax. "We are reviewing the agency's feedback
and intend to request a meeting with the FDA to evaluate options
for providing additional data to support the four-dose regimen for
this vulnerable patient population in the U.S."
Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused
by all known subtypes of hepatitis B virus in adults aged 18 years
and older.
For full U.S. Prescribing Information for
HEPLISAV-B, click here.
Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history
of a severe allergic reaction (e.g., anaphylaxis) after a previous
dose of any hepatitis B vaccine or to any component of HEPLISAV-B,
including yeast.
Appropriate medical treatment and supervision must be available
to manage possible anaphylactic reactions following administration
of HEPLISAV-B.
Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not
prevent hepatitis B infection in individuals who have an
unrecognized hepatitis B infection at the time of vaccine
administration.
The most common patient-reported adverse reactions reported
within 7 days of vaccination were injection site pain (23% to 39%),
fatigue (11% to 17%), and headache (8% to 17%).
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
adjuvant as a premier vaccine adjuvant with adjuvanted vaccine
clinical programs for shingles and Tdap, and through 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