Valneva: Renowned Vaccinologist Dr.
Stanley Plotkin to Present at R&D Investor Day in New York City
on July 9th
Live webcast beginning at 8:30am EDT / 2:30pm
CEST
Saint-Herblain (France), July 3,
2019 – Valneva SE (“Valneva” or “the Company”), a biotech
company developing and commercializing vaccines for infectious
diseases with major unmet medical needs, today announced that
renowned vaccinologist Dr. Stanley A. Plotkin, MD will present on
Lyme disease and chikungunya at its Research & Development
(R&D) Investor Day on Tuesday, July 9th, 2019 in New York City,
from 8:30a.m. to 11:00a.m. Eastern Daylight Time (EDT).
Dr. Plotkin serves as a consultant to the
vaccine industry and is an emeritus professor at both the Wistar
Institute and University of Pennsylvania. He developed the rubella
vaccine, which is now used worldwide, and has played a pivotal role
in both the development and application of various other vaccines
including: polio, rabies, varicella, rotavirus and cytomegalovirus.
He is the author of more than 600 research papers and has edited
several books including, Vaccines. Dr. Plotkin has served as the
senior assistant surgeon with the Epidemic Intelligence Service,
U.S. Public Health Service, director of the division of infectious
diseases at Children’s Hospital of Philadelphia, associate chairman
of the department of paediatrics, University of Pennsylvania and
Medical Director at Sanofi Pasteur for seven years. Due to his
personal interest in a Lyme vaccine, Dr. Plotkin does not receive
remuneration or any benefits from Valneva. Furthermore, Dr. Plotkin
does not hold any stock or stock options in the Company.
As previously announced, Valneva’s Chief
Executive Officer Thomas Lingelbach and Chief Medical Officer
Wolfgang Bender, MD, PhD, will give a full update on the Company’s
two leading vaccine clinical development programs, VLA15 (Lyme
disease) and VLA1553 (chikungunya).
Valneva’s vaccine candidate VLA15 is the only
Lyme disease vaccine in clinical development worldwide, while the
Company’s unique chikungunya vaccine candidate, VLA1553, has
potential single-shot long-term efficacy.
R&D Day Event DetailsThe
event will be held on Tuesday, July 9th at the Parker Hotel in New
York City. Doors will open at 7:45a.m. for registration and
breakfast, and the event will end around 11:00a.m. Please RSVP in
advance if you plan to attend, as space is limited. For those
who are unable to attend in person, a live webcast and replay will
be accessible via the link here.
For further information please visit www.valneva.com or email
the Investor Relations team at investors@valneva.com.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria transmitted to
humans by infected Ixodes ticks1. It is considered the most common
vector borne illness in the Northern Hemisphere. According to the
US Centers for Disease Control and Prevention (CDC), approximately
300,000 Americans2 are diagnosed with Lyme disease each year with
at least a further 200,000 cases in Europe3. 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 widens4.
About VLA15Valneva’s vaccine
candidate, VLA15, is currently the only active vaccine program in
clinical development against Lyme disease. The program was granted
Fast Track designation by the U.S. Food and Drug Administration
(FDA) in July 20175 . Valneva reported final Phase 1 data
demonstrating VLA15’s favorable safety profile and immunogenicity
in all doses and formulations tested, with good OspA-specific IgG
antibody responses against all OspA serotypes. In addition, VLA15
elicited an excellent anamnestic response following a booster
vaccination in a time window of 12 to 15 months after initial
primary immunization6. As part of the ongoing Phase 2, two higher,
alum-adjuvanted formulations have been selected for further
development7.VLA15 is a multivalent, protein subunit vaccine that
targets the outer surface protein A (OspA) of Borrelia. It is
designed for prophylactic, active immunization against Lyme disease
aiming for protection against the majority of human pathogenic
Borrelia species in Europe and the US. VLA15 is designed to confer
protection by raising antibodies that prevent Borrelia from
migrating from ticks to humans after a bite. The safety profile is
expected to be similar to other lipidated protein based vaccines
that are approved for active immunization in adults and
children.The target population includes individuals at risk above 2
years of age living in endemic areas, people planning to travel to
endemic areas to pursue outdoor activities and people at risk who
have a history of Lyme disease (as infection with Borrelia does not
confer protective immunity against all pathogenic Borrelia
species). Vaccination with OspA was proven to work in the 1990s and
VLA15 pre-clinical data showed that the vaccine has the potential
to provide protection against the majority of the Borrelia species
pathogenic for humans8.
About Chikungunya Chikungunya
is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Clinical symptoms include acute onset of fever, debilitating joint
and muscle pain, headache, nausea and rash, potentially developing
into long-term, serious health impairments. Chikungunya virus
causes clinical illness in 72-92% of infected humans around 4 to 7
days after an infected mosquito bite. Complications resulting from
the disease include visual, neurological, heart and
gastrointestinal manifestations; fatalities have been reported
(case fatality rates of 0.1% to 4.9% from epidemics)9 in elderly
patients at higher risk. Chikungunya outbreaks have been reported
in Asia, Africa, the Americas and recently (2017) in Europe. As of
2017, there have been more than one million reported cases in the
Americas10 and the economic impact is considered to be
significant (e.g. Colombia outbreak 2014: $73.6m11). The medical
and economic burden is expected to grow as the CHIKV primary
mosquito vectors continue to further 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
monovalent, single dose, live-attenuated vaccine candidate for
protection against chikungunya and was granted Fast Track
designation by the U.S. Food and Drug Administration (FDA) in
December 201812. The vaccine candidate is designed for
prophylactic, active, single-dose immunization against chikungunya
in humans over one year old. The vaccine targets long-lasting
protection and an anticipated safety profile similar to licensed
vaccines for active immunization in adults and children. The target
population segments are travelers, military personnel and
individuals at risk living in endemic regions. The global market
for vaccines against chikungunya is estimated at up to €500 million
annually13.VLA1553 is based on an infectious clone (CHIKV
LR2006-OPY1) attenuated by deleting a major part of the gene
encoding the non-structural replicase complex protein nsP3, aiming
for protection against various chikungunya virus outbreak
phylogroups and strains14. In pre-clinical development, a
single-vaccine shot was shown to be highly immunogenic in
vaccinated Non-Human Primates (NHP) (cynomolgus macaques) and
showed no signs of viremia after challenge15. In NHPs, VLA1553
induced a strong, long lasting (more than 300 days) neutralizing
antibody response comparable to wild-type CHIKV infections,
combined with a good safety profile.
About Valneva SEValneva is a
biotech company developing and commercializing vaccines for
infectious diseases with major unmet needs. 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. The Company has various
vaccines in development including a unique vaccine against Lyme
disease. Valneva has operations in Austria, Sweden, the United
Kingdom, France, Canada and the US with approximately 480
employees. More information is available at www.valneva.com.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineGlobal Head of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@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 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 indicative of their
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 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 Stanek et al. 2012, The Lancet 379:461–4732 As estimated by
the CDC, https://www.cdc.gov/lyme/stats/humancases.html.3 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-report4 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/5
https://www.valneva.com/en/investors-media/news/2017#2706
https://www.valneva.com/en/investors-media/news/2019#3097
https://www.valneva.com/en/investors-media/news/2019#3198
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113294.9
WHO, PAHO10 PAHO/WHO data: Number of reported cases of Chikungunya
Fever in the Americas – EW 51 (December 22, 2017)11 Cardona-Ospina
et al., Trans R Soc Trip Med Hyg 201512 Valneva PR: Valneva Awarded
FDA Fast Track Designation for Chikungunya vaccine candidate13
Company estimate support by an independent market study14
Hallengärd et al. 2013 J. Virology 88: 2858-286615 Roques et al.
2017JCI Insight 2 (6): e83527
- 2019_07_03_VLA_R&D_Day_KOL_PR_EN