EMERYVILLE, Calif.,
Oct. 18, 2021 /PRNewswire/
-- Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
vaccines, today announced that Valneva SE reported positive topline
results from the Phase 3 pivotal trial of VLA2001, their
inactivated COVID-19 vaccine candidate using Dynavax's CpG 1018®
adjuvant.
Valneva reported the following data from their Phase 3
COV-COMPARE trial in a press release issued October 18, 2021. The trial met its co-primary
endpoints: VLA2001 demonstrated superiority against AZD1222
(ChAdOx1-S), in terms of geometric mean titer for neutralization
antibodies (GMT ratio=1.39, p<0.0001), (VLA2001 GMT 803.5 (95%
CI: 748.48, 862.59)), (AZD1222(ChAdOx1-S) GMT 576.6 (95% CI 543.6,
611.7)), as well as non-inferiority in terms of seroconversion
rates (SCR above 95% in both treatment groups) at two weeks after
the second vaccination (i.e. Day 43) in adults aged 30 years and
older. VLA2001 was generally well-tolerated. The tolerability
profile of VLA2001 was significantly more favorable compared to the
active comparator vaccine. Participants 30 years and older reported
significantly fewer solicited adverse events up to seven days after
vaccination, both with regards to injection site reactions and
systemic reactions (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S),
p<0.0001) and systemic reactions (70.2% VLA2001 vs. 91.1%
AZD1222 (ChAdOx1-S), p<0.0001). No unsolicited treatment-related
serious adverse events (SAE) have been reported. Less than 1%
reported an adverse event of special interest in both treatment
groups. Participants in the younger age group vaccinated with
VLA2001 showed an overall safety profile comparable to the older
age group.
Ryan Spencer, Chief Executive
Officer of Dynavax commented, "With these results announced by
Valneva, our CpG 1018 adjuvant has now been shown to help
drive a robust immune response while maintaining a favorable
tolerability profile in multiple phase 3 trials across different
vaccine platforms. This data further supports the value of CpG 1018
in the global response to the pandemic and as a platform for
developing new and improved vaccines. We look forward to continuing
to support Valneva in the development and approval of their
inactivated COVID-19 vaccine to make it available to those in
need."
About Valneva's Phase 3 Trial Cov-Compare
(VLA2001-301)
Cov-Compare (VLA2001-301) is a randomized, observer-blind,
controlled, comparative immunogenicity trial in 4,012 adults and
660 adolescents. Co-Primary immunogenicity endpoints are
superiority of GMT ratio of VLA2001 compared to AZD1222 (ChAdOx1-S)
as well as non-inferiority of seroconversion rates of neutralizing
antibodies administered in a two-dose immunization schedule four
weeks apart, measured at two weeks after the second vaccination
(i.e. Day 43) in adults aged 30 years and older. It also evaluates
the safety and tolerability of VLA2001 at two weeks after the
second vaccination in adults and adolescents aged 12 years and
older. The trial is being conducted at 26 sites across the U.K.
2,972 participants 30 years of age and older were randomized in a
2:1 ratio to receive two intramuscular doses of either VLA2001
(n=1,977) or AZD1222 (ChAdOx1-S) (n=995) at the recommended dose
level, 28 days apart, on Days 1 and 29. For immunogenicity
analyses, samples from 990 participants (492 vaccinated with
VLA2001, 498 vaccinated with AZD1222 (ChAdOx1-S)) who tested
sero-negative for SARS-CoV-2 at screening were analyzed. 1,040
participants that are under 30 years of age were recruited in a
non-randomized treatment group and received VLA2001 28 days apart.
Safety data on those participants aged 18-29 years of age are
analyzed in parallel to the adults aged 30 years and above.
Recently, the trial commenced enrolling the first adolescent
participants.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used
in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an
enhanced vaccine immune response, which has been demonstrated in
HEPLISAV-B and in multiple COVID-19 vaccine candidates. CpG 1018
adjuvant provides a well- developed technology and a significant
safety database, supporting development and large-scale
manufacturing of a COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. and Europe for prevention of
infection caused by all known subtypes of hepatitis B virus in
adults age 18 years and older. Dynavax is also advancing CpG 1018
adjuvant as an advanced vaccine adjuvant through research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, pertussis and universal
influenza. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
Forward-Looking Statements
This press release contains
"forward-looking statements," including statements regarding
expected results for an ongoing contractual relationship and
expected business results. 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," "will," "would" and similar expressions, or they may use
future dates. Forward-looking statements in this document include,
without limitation, statements regarding our expectations as to
outcomes relating to ongoing collaborations and contractual
relationships, the timing of regulatory approvals and product
launches, our ability to support Valneva's vaccine development
program and our expected financial performance. These
forward-looking statements are subject to assumptions, risks and
uncertainties that may change at any time, and readers are
therefore cautioned that actual results could differ materially
from those expressed in any forward-looking statements. Factors
that could cause actual results to differ include, among other
things: risks and uncertainties associated with actual results of
clinical trials conducted by Valneva as well as our other
collaborators; whether and when Valneva's vaccine will be approved
for use and launched; whether sufficient quantities of CpG 1018
will be able to be manufactured; whether or how much Gavi or other
commercial customers purchase from Valneva; and other risks and
uncertainties discussed in the Company's filings with the SEC,
including the "Risk Factors" sections of the Company's Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021. The Company undertakes no
obligation to update any forward-looking statements as a result of
new information, future developments or otherwise, except as
expressly required by law. All forward-looking statements in this
document are qualified in their entirety by this cautionary
statement.
Contacts:
Nicole Arndt,
Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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SOURCE Dynavax Technologies