- Phase 2 study VLA15-202 met its endpoints
- VLA15 generally safe across all dose and age groups tested
- Immunogenicity further increased in VLA15-202 compared to
VLA15-201
- Seroconversion Rates exceeded 90% across all serotypes,
including in older adults (50-65 years)
- Functionality of antibodies was demonstrated across all
serotypes using a Serum Bactericidal Assay
Saint-Herblain (France), October 20,
2020 – Valneva SE (“Valneva”), a specialty vaccine company
focused on prevention of diseases with major unmet needs, today
announced positive initial results for its second Phase 2 study
(VLA15-202) of Lyme disease vaccine candidate VLA15. Compared to
study VLA15-201, study VLA15-202 investigated a vaccination
schedule of Month 0-2-6 based on matching doses.
VLA15 was generally safe across all doses and
age groups tested. The tolerability profile including fever rates
was comparable to other lipidated recombinant vaccines or lipid
containing formulations. As in VLA15-201, no related Serious
Adverse Events (SAEs) were observed in any treatment group.
Reactogenicity decreased following the first vaccination.
Compared to study VLA15-201, immunogenicity was
further enhanced using a Month 0-2-6 schedule. SCRs
(Seroconversion Rates), after completion of the primary vaccination
series, showed similar responses and ranged from 93.8% [ST1] to
98.8% [ST2, ST4]. Antibody responses were comparable in the two
dose groups tested.
The immunological response in older adults, one of the main
target groups for a Lyme vaccine, is particularly encouraging, as
already observed in VLA15-201.
Furthermore, results did not indicate that prior
exposure to Borrelia spirochetes (sero-positivity) has an impact on
immunogenicity or safety, also as observed in VLA15-201.
A Serum Bactericidal Assay (SBA), assessing the
functional immune response against Lyme disease after vaccination
with VLA15, was conducted for the first time and demonstrated
functionality of antibodies against all OspA serotypes. Assays,
such as SBAs, are commonly used to enable a potential prediction of
vaccine efficacy via the measurement of vaccine-induced functional
immune responses.
Juan Carlos Jaramillo, MD, Chief Medical
Officer of Valneva, commented, “We are extremely pleased
with these results which showed an excellent immunological profile,
further supported by additional positive data through the Serum
Bactericidal Assay (SBA). With these encouraging data we are now
well positioned to continue development. Lyme disease continues to
be a high unmet medical need and our objective remains to work
closely with Pfizer to offer a preventative solution as soon as
possible.”
VLA15-202 Day 208 safety and immunogenicity data
support advancing the program with the Month 0-2-6 schedule.
Valneva and Pfizer will finalize dosage analysis and prepare for
the next development steps in the coming months.
About Phase 2 Clinical Study
VLA15-202 VLA15-202, the second Phase 2 study, is a
randomized, observer-blind, placebo controlled trial conducted in
the US. A total of 246 volunteers received 135 µg or 180 µg of
VLA15 (approximately 100 subjects each) or placebo (approximately
50 subjects).VLA15 was tested as alum adjuvanted formulation and
was administered intramuscularly in three injections, given at
Month 0, 2 and 6 (compared to Month 0, 1 and 2 in study VLA15-201).
Subjects are followed for 18 months, with the main immunogenicity
readout at one month after completion of the primary vaccination
series (primary endpoint). The study enrolled healthy adults 18 to
65 years of age. Study centers are located in areas where Lyme
disease is endemic; volunteers with a cleared past infection with
Borrelia burgdorferi, the bacteria that cause Lyme disease, were
also enrolled.
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 strong
immunogenicity and safety data in pre-clinical, Phase 1 and Phase
2studies. The program was granted Fast Track designation by the
U.S. Food and Drug Administration (FDA) in July 20171. Valneva and
Pfizer announced a collaboration for VLA15’s development and
commercialization at the end of April 20202. The two companies are
working closely together on the next development steps.
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia bacteria transmitted to
humans by infected Ixodes ticks3. 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 Americans4 are diagnosed with Lyme disease
each year with at least a further 200,000 cases in Europe5. 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
widens6.
About Valneva SEValneva is a
specialty vaccine company focused on prevention of 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. Valneva has various vaccines in
development including unique vaccines against Lyme disease,
COVID-19 and chikungunya. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit www.valneva.com and follow
the Company on LinkedIn.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector 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
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or otherwise.
1 Valneva Receives FDA Fast Track Designation for its Lyme
Disease Vaccine Candidate VLA152 Valneva and Pfizer Announce
Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine,
VLA153 Stanek et al. 2012, The Lancet 379:461–4734 As estimated by
the CDC, https://www.cdc.gov/lyme/stats/humancases.html.5 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-report6 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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