Dynavax Presents Analysis of Data for Participants Aged 60 to 70 with Diabetes from its Phase 3 Trial of HEPLISAV-B®
June 25 2018 - 12:05PM
In a Post-Hoc Analysis of Elderly Diabetic
Patients, HEPLISAV-B was Well-Tolerated and Induced Higher Rates of
Seroprotection than Engerix-B
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced
results of a post hoc analysis of data from HBV 23, the pivotal
Phase 3 trial of its hepatitis B vaccine HEPLISAV-B® [Hepatitis B
Vaccine, Recombinant (Adjuvanted)]. HBV 23 was a randomized,
observer-blinded, active-controlled, multi-center study that
compared two doses of HEPLISAV-B over four weeks with three doses
of Engerix-B® [Hepatitis B Vaccine (Recombinant)] over 24 weeks in
8,374 adults age 18 to 70. This post hoc analysis evaluated data
from the trial for participants with type 2 diabetes aged 60 to 70.
These data were presented at the 2018 American Diabetes Association
(ADA) Annual Meeting in Orlando, FL on Monday, June 25 at 12:00pm
ET.
Highlights from Poster Presentation
• In the per protocol (PP) analysis, the seroprotection
rate at week 28 for HEPLISAV-B (n=274) was 85.8% compared to 58.5%
for Engerix-B (n=130), a treatment difference of 27.3% (95% CI:
18.0% – 36.8%)• HEPLISAV-B induced higher geometric mean
concentration (GMCs) (137.3 mIU/mL) in the per-protocol analysis at
week 24 than Engerix-B at week 28, with a GMC ratio of 2.7 (95%,
[CI: 1.6 – 4.4])• HEPLISAV-B had a similar safety
profile compared to Engerix-B, regardless of study subgroup, which
included smoking status, body mass index and sex
- In the HEPLISAV-B group, 64.2% of the participants reported a
medically attended adverse event (MAE), of those 23.5% experienced
a grade 3 or 4 MAE; in the Engerix-B group 55.6% of participants
experienced MAEs, of those 22.2% reported a grade 3 or 4 MAE
“These data in elderly diabetic patients show the benefit of
HEPLISAV-B in a population that is more difficult to protect and,
when infected, typically demonstrates a more severe hepatitis B
disease,” said Dr. Rob Janssen, chief medical officer of Dynavax.
“We believe there is a great opportunity for Dynavax to contribute
to the overall health of the adult population with diabetes.”
The post hoc analysis consisted of participants from the
randomized study that received either two doses of HEPLISAV-B
(n=327) or three doses of Engerix-B (n=153). HEPLISAV-B was
administered at 0 and 4 weeks, followed by placebo at 24 weeks to
maintain blinding. Engerix-B was injected at 0, 4, and 24 weeks.
Both vaccines were administered intramuscularly into the deltoid
muscle.
The phase 3 trial included a total of 961 participants with type
2 diabetes aged 18 to 70. The primary endpoint for this subgroup
compared the seroprotection rate at Week 28 for HEPLISAV-B (n= 640)
with that at Week 28 for Engerix-B (n= 321). This analysis showed
that HEPLISAV-B resulted in a 90.0% seroprotection rate compared to
a 65.1% seroprotection rate from Engerix-B.
About HEPLISAV-BHEPLISAV-B is an adult
hepatitis B vaccine that combines hepatitis B surface antigen with
Dynavax’s proprietary Toll-like receptor (TLR) 9 agonist to enhance
the immune response. Dynavax has worldwide commercial rights to
HEPLISAV-B.
For more information about HEPLISAV-B, visit
http://heplisavb.com/.
Indication and Use HEPLISAV-B is indicated for
prevention of infection caused by all known subtypes of hepatitis B
virus in adults age 18 years and older.
Important Safety Information (ISI)Do not
administer HEPLISAV-B to individuals with a history of 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%).
For full Prescribing Information for
HEPLISAV-B, click here.
About DynavaxDynavax is a fully-integrated
biopharmaceutical company focused on leveraging the power of the
body's innate and adaptive immune responses through toll-like
receptor (TLR) stimulation. Dynavax discovers and develops novel
vaccines and immuno-oncology therapeutics. The Company’s first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], is approved in the United States. Dynavax's lead
immunotherapy product, SD-101, is an investigational cancer
immunotherapeutic currently being evaluated in Phase 1/2 studies
and its second cancer immunotherapeutic, DV281, is in Phase 1
development. For more information, visit www.dynavax.com.
Forward-Looking Statements This press release
contains forward-looking statements, including statements regarding
the commercial launch of HEPLISAV-B. These statements are subject
to a number of risks and uncertainties that could cause actual
results to differ materially, including whether the company will be
able to continue building the commercial infrastructure required to
successfully launch HEPLISAV-B; whether payers will provide timely
reimbursement for HEPLISAV-B; whether prescribers and other key
decision-makers will switch to HEPLISAV-B; and whether potential
claims against us, including those based on patent rights of
others, will result in an injunction against sales or otherwise
impact commercialization and sales. For a further description
of the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of Dynavax in general, see
risks detailed in the "Risk Factors" section of our most recent
current periodic report filed with the SEC. These statements
represent our estimates and assumptions only as of the date of this
press release. We do not undertake any obligation to update
publicly any such forward-looking statements, 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.
Engerix-B is a registered trademark of the GSK group of
companies.
US-18-01-00128
Contact: Ryan SpencerVP, Corporate Strategy &
Communications510.665.4618rspencer@dynavax.com |
Media
Contact:Rachel St. MartinW2O wcg 646.894.5757
rstmartin@w2ogroup.com |
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Apr 2024 to May 2024
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From May 2023 to May 2024