- Phase 2 study VLA15-221 planned to be initiated in Q1 2021,
subject to regulatory approval
- First clinical study of VLA15 that includes a pediatric
population, aged 5-17 years
- Study will include participants from 5-65 years of age and a
reduced immunization schedule (Month 0-6 compared to Month
0-2-6)
- The study will trigger a milestone payment, upon dosing of the
first subject, from Pfizer to Valneva of $10 million
- Phase 3 pivotal efficacy trial is planned to commence in
2022
Saint-Herblain (France), December
2, 2020 – Valneva SE
(“Valneva”), a specialty vaccine company focused on prevention of
diseases with major unmet needs, today announced its plans to
accelerate pediatric development of its Lyme vaccine candidate,
VLA15, in collaboration with Pfizer Inc. (NYSE: PFE), with the
planned initiation of study VLA15-221 in the first quarter of 2021,
subject to regulatory approval.
VLA15-221 is planned as a randomized,
observer-blind, placebo-controlled Phase 2 study. Currently, the
study will include approximately 600 healthy participants (5-65
years of age) who will receive VLA15 at the dose of 180µg, which
was selected based on recent data generated in the two ongoing
Phase 2 studies.
If approved, it will be the first clinical study
of VLA15 to enroll a pediatric population aged 5-17 years and will
compare the three-dose vaccination schedule Month 0-2-6 with a
reduced two-dose schedule of Month 0-6.
“This will be an important
study that we anticipate will provide evidence that the vaccine can
be used in the populations that are at risk of the devastating
consequences of Lyme disease, using a simplified schedule,” said
Kathrin Jansen, Senior Vice President and Head of Pfizer
Vaccine Research and Development.
This study will complement the two ongoing Phase
2 studies VLA15-201 (initial positive data reported on 22nd July
20201) and VLA15-202 (initial positive data reported on 20th
October 20202). Initial data from study VLA15-221 (primary
endpoint) are expected by the second quarter of 2022. VLA15-221
will also investigate a booster dose of VLA15, administered one
year following the 6 Month dose. All three Phase 2 trials are
anticipated to support a Phase 3 pivotal efficacy trial including
all main target populations for the Lyme vaccine candidate starting
in 2022.
Juan Carlos Jaramillo, MD, Chief Medical
Officer of Valneva commented “We believe that including
the pediatric population early on could provide support for the
Phase 3 study to include all major target groups for our future
Lyme vaccine candidate and may potentially support successful
market access including respective recommendations. We are pleased
that Pfizer and Valneva have decided to accelerate this development
step while preparing for a potential Phase 3 start, expected in
2022.”
Valneva and Pfizer entered into a collaboration
agreement in April 2020 to co-develop and commercialize VLA15.
Under the terms of the agreement, first subject,
first dose in this study will trigger a milestone payment of $10
million from Pfizer to Valneva. The original Valneva plan, prior to
the Pfizer agreement, assumed age de-escalation post-licensure. The
Pfizer collaboration allows acceleration of pediatric
development.
About VLA15VLA15 is the only
active Lyme disease vaccine in clinical development today, and
covers six serotypes that are prevalent in North America and
Europe. This investigational multivalent protein subunit vaccine
targets the outer surface protein A (OspA) of Borrelia, an
established mechanism of action for a Lyme disease vaccine. OspA is
one of the most dominant surface proteins expressed by the bacteria
when present in a tick. VLA15 has demonstrated promising
immunogenicity and safety data in pre-clinical and clinical studies
so far. The program was granted Fast Track designation by the U.S.
Food and Drug Administration (FDA) in July 20173. Valneva and
Pfizer announced a collaboration for VLA15’s development and
commercialization at the end of April 20204. The two companies are
working closely together on the next development steps.
About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo controlled Phase
2 study. It is the first clinical study with VLA15 that will enroll
a pediatric population aged 5 years and older. A total of
approximately 600 participants will receive VLA15 at two different
immunization schedules (Month 0-2-6 or Month 0-6, 200 volunteers
each) or placebo (Month 0-2-6, 200 volunteers). The main safety and
immunogenicity readout (Primary Endpoint analysis) is anticipated
at Month 7, where peak antibody titers are expected. A subset of
participants will receive a booster dose of VLA15 or placebo at
Month 18 (Booster Phase) and will be followed for three further
years to monitor the antibody persistence.VLA15 will be tested as
an alum-adjuvanted formulation and administered intramuscularly.
The study will be conducted at sites which are located in areas
where Lyme disease is endemic and will enroll volunteers with a
cleared past infection with Borrelia burgdorferi, the bacteria that
cause Lyme disease, as well as B. burgdorferi naïve volunteers.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria burgdorferi
sensu lato transmitted to humans by infected Ixodes ticks5. It is
considered the most common vector borne illness in the Northern
Hemisphere. According to the U.S. Centers for Disease Control and
Prevention (CDC), approximately 300,000 Americans6 are diagnosed
with Lyme disease each year with at least a further 200,000 cases
in Europe7. Early symptoms of Lyme disease (such as a gradually
expanding erythematous rash called Erythema migrans or more
unspecific symptoms like fatigue, fever, headache, mild stiff neck,
arthralgia or myalgia) are often overlooked or misinterpreted. Left
untreated, the disease can disseminate and cause more serious
complications affecting the joints (arthritis), the heart
(carditis) or the nervous system. The medical need for vaccination
against Lyme disease is steadily increasing as the disease
footprint widens8.
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. The Company has several vaccines in
development including vaccines against Lyme disease, COVID-19 and
chikungunya. Valneva’s portfolio includes two commercial vaccines
for travelers: IXIARO®/JESPECT® indicated for the prevention of
Japanese encephalitis and DUKORAL® indicated for the prevention of
cholera and, in some countries, prevention of diarrhea caused by
ETEC. For more information, visit www.valneva.com and follow the
Company on LinkedIn.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
|
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, design, data read-outs, anticipated results and completion
of clinical trials for VLA15 and the expected milestone payment
from Pfizer to Valneva. 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 indicative of future results. 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 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, the ability to obtain or
maintain patent or other proprietary intellectual property
protection and the impact of the COVID-19 pandemic. 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 this
press release as of the date hereof 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 Valneva Announces Positive Initial Results for Phase 2 Study
of Lyme Disease Vaccine Candidate
2 Valneva Announces Positive Initial Results for Second Phase 2
Study of Lyme Disease Vaccine Candidate VLA15
3 Valneva Receives FDA Fast Track Designation for its Lyme
Disease Vaccine Candidate VLA15
4 Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15
5 Stanek et al. 2012, The Lancet 379:461–473
6 As estimated by the CDC,
https://www.cdc.gov/lyme/stats/humancases.html.
7 Estimated from available national data. Number largely
underestimated based on WHO Europe Lyme Report as case reporting
is
highly inconsistent in Europe and many LB infections go
undiagnosed; ECDC tick-borne-diseases-meeting-report
8 New Scientist, Lyme disease is set to explode and we still
don’t have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
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