- Pivotal study VLA1553-301 met its primary
endpoint
- Vaccine candidate induced protective
CHIKV neutralizing antibody titers in
98.5% of subjects after a single
vaccination
- VLA1553 was well tolerated across all
age groups
- Final trial results expected within the next six
months
Saint Herblain
(France), August
5, 2021 – Valneva SE
(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company
focused on the development and commercialization of prophylactic
vaccines for infectious diseases with significant unmet medical
need, today announced positive topline results from the Phase 3
pivotal trial of its single-shot chikungunya vaccine candidate,
VLA1553. VLA1553 was recently awarded Breakthrough Designation
status by the Food and Drug Administration (FDA).
The trial, involving 4,115 adults, aged 18 years
and above, across 44 sites in the U.S., met its primary endpoint
inducing protective CHIKV neutralizing antibody titers in 98.5% of
participants 28 days after receiving a single shot (264 of 268
subjects from the per-protocol subgroup tested for immunogenicity,
95%CI: 96.2-99.6). The seroprotection rate result of 98.5% exceeded
the 70% threshold (for non-acceptance) agreed with the FDA. The
seroprotective titer was agreed with the FDA to serve as a
surrogate of protection that can be utilized in a potential FDA
submission of VLA1553 under the accelerated approval pathway. The
vaccine candidate was highly immunogenic with a GMT of
approximately 3,270, confirming the immunogenicity profile seen in
the Phase 1 trial.
Additionally, VLA1553 was also highly
immunogenic in elderly study participants, who achieved equally
high seroprotection rates and neutralizing antibody titers as
younger adults, as well as an equally good safety profile.
VLA1553 was generally well tolerated among the
3,082 subjects evaluated for safety. An independent Data Safety
Monitoring Board continuously monitored the study and identified no
safety concerns. The safety profile is consistent with results from
the Phase 1 clinical trial. The majority of solicited adverse
events were mild or moderate and resolved within 3 days. 1.6% of
study participants reported severe solicited adverse events, most
commonly fever. Approximately 50% of study participants experienced
solicited systemic adverse events, most commonly headache, fatigue
and myalgia (seen in more than 20% of subjects). The local
tolerability profile showed that approximately 15% of participants
experienced solicited local adverse events.
Juan Carlos Jaramillo,
M.D, Chief Medical Officer of Valneva
commented, “We are delighted with these Phase 3 results
confirming the compelling profile of our vaccine candidate across
all age groups. These first-ever Phase 3 trial results for a
chikungunya vaccine mean that we are a step closer to addressing
this major, growing and unmet public health threat. I would like to
thank everyone who participated in the trial and who continued to
advance the trial during the pandemic. We will continue to work
with regulators to bring VLA1553 to market as soon as
possible.”
The trial will continue towards final analysis
including the 6-month safety data. Final trial results are expected
within the next six months. The sponsor of the first chikungunya
vaccine approved in the U.S. will be eligible to receive a Priority
Review Voucher (PRV).
The program was awarded Breakthrough Therapy
Designation by the FDA in July 2021. This new milestone came in
addition to the FDA Fast Track designation and the European
Medicines Agency (EMA)’s PRIME designation which the Company
received in December 2018 and in October 2020, respectively.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Infection leads to symptomatic disease in 72-92% of humans after 4
to 7 days following the mosquito bite. While mortality with CHIKV
is low, morbidity is high. Clinical symptoms include acute onset of
fever, debilitating joint and muscle pain, headache, nausea, rash
and chronic arthralgia. Chikungunya virus often causes sudden large
outbreaks with high attack rates, affecting one-third to
three-quarters of the population in areas where the virus is
circulating. The high risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia. As of
September 2020, there were more than 3 million reported cases in
the Americas1 and the economic impact is considered to be
significant. The medical and economic burden is expected to grow as
the CHIKV primary mosquito vectors continue to spread
geographically. There are no preventive vaccines or effective
treatments available and, as such, chikungunya is considered to be
a major public health threat.
About VLA1553VLA1553 is a
live-attenuated, single dose vaccine candidate targeting the
chikungunya virus, which has spread to more than 100 countries. It
has been designed by deleting a part of the chikungunya virus
genome. To Valneva’s knowledge, VLA1553 is currently the only
chikungunya vaccine candidate in Phase 3 clinical trials that
targets long-term protection following the administration of a
single dose.In the Phase 1 clinical trial, Valneva observed
development of antibodies to chikungunya virus resulting in 100%
seroconversion of the 120 healthy participants. Antibody titers
were sustained after 12 months. Based on these results and
Valneva’s discussions with regulators, VLA1553 advanced directly
into Phase 3 clinical development. The Company has also received
confirmation for its proposal to seek licensure under the
accelerated approval pathway from the FDA. Under this pathway,
Valneva plans to seek licensure of the vaccine based on a surrogate
of protection agreed with the FDA that is reasonably likely to
predict protection from chikungunya infection. VLA1553 would expand
Valneva’s existing travel vaccine portfolio and as such, Valneva
intends to commercialize this vaccine, if approved, leveraging its
existing manufacturing and commercial operations. The global market
for vaccines against chikungunya is estimated to exceed $500
million annually by 20322.To make VLA1553 more accessible to Low
and Middle Income Countries (LMIC), Valneva and Instituto Butantan
in Brazil signed an agreement for the development, manufacturing
and marketing of VLA1553. The collaboration falls within the
framework of the funding agreement between Valneva and the
Coalition for Epidemic Preparedness Innovations (CEPI) signed in
July 2019, which provides funding of up to $23.4 million with
support from the European Union’s Horizon 2020 program.
About Phase 3 trial
VLA1553-301 VLA1553-301 Phase 3 trial was
initiated in September 2020. It is a prospective, double-blinded,
multicenter, randomized, pivotal Phase 3 trial evaluating 4,115
participants aged 18 years or above. Lyophilized VLA1553 or placebo
were administered as a single intramuscular immunization. The
primary objective of the trial was to evaluate the immunogenicity
and safety of VLA1553 28 days following a single immunization.
Safety data and immunogenicity will continue to be assessed until
Month 6; further long-term follow up is ongoing. Additional
information, including a detailed description of the trial design,
eligibility criteria and investigator sites, is available at
ClinicalTrials.gov (Identifier: NCT04546724).
About Valneva SEValneva is a
specialty vaccine company focused on the development and
commercialization of prophylactic vaccines for infectious diseases
with significant unmet medical need. The Company takes a highly
specialized and targeted approach to vaccine development, beginning
with the identification of deadly and debilitating infectious
diseases that lack a prophylactic vaccine solution and for which
there are limited therapeutic treatment options. It then applies
its deep understanding of vaccine science, including its expertise
across multiple vaccine modalities, as well as its established
vaccine development capabilities, to develop prophylactic vaccines
to address these diseases. Valneva has leveraged its expertise and
capabilities to successfully commercialize two wholly owned
vaccines and rapidly advance multiple vaccine candidates into
late-stage clinical development, including candidates against Lyme
disease (partnered with Pfizer), the chikungunya virus and
COVID-19.
Media
& Investors ContactsLaëtitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
DrummVP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
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Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, results and completion of research, development and
clinical trials for product candidates and estimates for future
performance. In addition, even if the actual results or development
of Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be sustained in the future. In some cases, you can
identify forward-looking statements by words such as "could,"
"should," "may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release, and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
1 PAHO/WHO data: Number of reported cases of chikungunya fever
in the Americas.
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 13 Oct 2020.2 VacZine Analytics Chikungunya virus
vaccines Global demand analysis. February 2020
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