Saint-Herblain (France), April 12, 2021 –
Valneva SE (“Valneva” or “the Company”), a specialty vaccine
company focused on the development and commercialization of
prophylactic vaccines for infectious diseases with significant
unmet medical need, today announced that it has completed
recruitment for the pivotal Phase 3 trial, VLA1553-301, of its
single-shot chikungunya vaccine candidate, VLA1553. The sponsor of
the first chikungunya vaccine Biologics License Application (BLA)
to be approved in the U.S. will be eligible to receive a Priority
Review Voucher (PRV) 1.
A total of 4,131 adults aged 18 or above have
been recruited across 44 sites in the US for the pivotal Phase 3
trial, VLA1553-301, which was launched in September 20202. If the
trial results are positive, the trial is expected to support
VLA1553’s licensure.
The primary endpoint of the double-blinded,
placebo-controlled study is to demonstrate safety and
immunogenicity 28 days after a single-shot vaccination with VLA1553
including a subset of participants (immunogenicity subset) tested
for sero-protection based on an immunological surrogate agreed with
the Food and Drug Administration (FDA). Participants will be
followed for six months in the pivotal trial. On April 1st 2021,
Valneva also initiated an antibody persistence trial, VLA1553-303,
that will follow the immunogenicity subset for a period of five
years.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of
Valneva, commented, “We are extremely pleased to have
reached this important milestone despite the ongoing COVID-19
pandemic affecting many people worldwide and creating challenges
for recruitment into clinical trials. Chikungunya virus is a major,
growing public health threat and we are looking forward to our top
line data in mid-2021. We would like to thank everyone involved, we
could not have achieved this important milestone without hard work
and dedication”.
About Chikungunya Chikungunya
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 Americas3 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
targeting the chikungunya virus, which has spread to more than 100
countries. VLA1553 is a live-attenuated, single dose vaccine
candidate for protection against chikungunya disease. It has been
designed by deleting a part of the chikungunya virus genome. To
Valneva’s knowledge, VLA1553 is the only chikungunya vaccine
candidate in Phase 3 clinical trials and the Company believes that
it is differentiated from other clinical stage chikungunya vaccine
candidates since VLA1553 is the only candidate that targets
long-term protection with a single administration.In the Phase 1
clinical trial of VLA1553, Valneva observed development of
antibodies to chikungunya virus resulting in 100% seroconversion of
the 120 healthy participants. These results were sustained after 12
months. Based on these results and Valneva’s discussions with
regulators, VLA1553 has advanced 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.
The program was granted Fast Track designation by the FDA in
December 2018 and PRIME designation by the European Medicines
Agency (EMA) in October 2020.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 20324.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.
About Phase 3 trial VLA1553-301
VLA1553-301 Phase 3 trial was initiated in September 2020 and
Valneva has now completed enrollment for this trial. Valneva
expects to report topline data in mid-2021. VLA1553-301 is a
prospective, double-blinded, multicenter, randomized, pivotal Phase
3 trial comprising 4,131 participants aged 18 years or above.
Lyophilized VLA1553 or placebo were administered as a single
intramuscular immunization. The primary objective of the trial is
to evaluate the immunogenicity and safety of the final dose of
VLA1553 28 days following a single immunization. Safety data
collection and immunogenicity will continue to be assessed until
Month 6; further long-term follow up is planned. Additional
information, including a detailed description of the trial design,
eligibility criteria and investigator sites, is available at
ClinicalTrials.gov (Identifier: NCT04546724).
About Phase 3 trial VLA1553-303
VLA1553-303 is a prospective, multicenter, Phase 3 antibody
persistence trial. Up to 375 participants vaccinated with VLA1553
in the pivotal trial VLA1553-301 will be enrolled in this follow-up
trial. The primary objective is to evaluate persistence of
antibodies annually for five years after a single immunization.
Additional information, including a detailed description of the
trial design, eligibility criteria and investigator sites, will be
published on ClinicalTrials.gov.
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. We take 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. We then apply our deep
understanding of vaccine science, including our expertise across
multiple vaccine modalities, as well as our established vaccine
development capabilities, to develop prophylactic vaccines to
address these diseases. We have leveraged our expertise and
capabilities both to successfully commercialize two vaccines and to
rapidly advance a broad range of vaccine candidates into and
through the clinic, including candidates against Lyme disease, the
chikungunya virus and COVID-19.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineDirector Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com
Dan SharpGovernment & Public Affairs Manager T
+44-(0)7436-244309communications@valneva.com
Forward-Looking Statements
This 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, the ability to manufacture, market, commercialize and
achieve market acceptance for product candidates, the ability to
protect intellectual property and operate the business without
infringing on the intellectual property rights of others, estimates
for future performance and estimates regarding anticipated
operating losses, future revenues, capital requirements and needs
for additional financing. 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. 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
disclaims 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 https://priorityreviewvoucher.org/
2 Valneva Initiates Phase 3 Clinical Study for its Chikungunya
Vaccine Candidate VLA1553
3 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.
4 VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 2020
- 2021_04_12_VLA1553_Ph3_Recruitment_Completion_PR_EN_Final
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