- Phase 2 study VLA15-201 met its endpoints
- Compared to Phase 1, the higher doses used in this trial
elicited higher antibody responses across all serotypes
- Encouraging immunogenicity profile confirmed, including older
adults (50-65 years)
- VLA15 generally safe across all dose and age groups tested
- No related Serious Adverse Events (SAEs) associated with
VLA15
Saint-Herblain (France), July
22, 2020 – Valneva SE
(“Valneva”), a specialty vaccine company focused on prevention of
diseases with major unmet needs, today announced positive initial
results for its first Phase 2 study (VLA15-201) of Lyme disease
vaccine candidate VLA15.
VLA15 was immunogenic across all dose groups
tested. Compared to Phase 1, the higher doses used in this trial
elicited higher antibody responses across all serotypes.
Seroconversion rates (SCR) in the highest dose ranged from 81.5%
(ST1) to 95.8% (ST2). In the age group comparable to the age group
investigated in Phase 1 (18-49 years), SCRs ranged from 85.6% to
97%. The immunological response in older adults, one of the main
target groups for a Lyme vaccine, is particularly
encouraging.Results did not indicate that prior exposure to Lyme
(sero-positivity) has an impact on immunogenicity or safety.As part
of further Phase 2 data to be released in a few months, an analysis
of the functionality of the antibodies generated with VLA15 will be
conducted. In close collaboration with regulatory authorities,
Valneva has developed a Serum Bactericidal Antibody assay (“SBA”)
for that purpose.
VLA15 was generally safe across all dose and age
groups tested. No related Serious Adverse Events (SAEs) were
observed with VLA15 in this study in any treatment group.
Reactogenicity decreased with subsequent vaccinations.Overall, the
tolerability profile including rates of fever appeared to be
comparable to other lipidated recombinant vaccines or
lipid-containing formulations.
Wolfgang Bender, MD, PhD, Chief Medical
Officer of Valneva commented “We are pleased to report a
successful first Phase 2 trial of our vaccine candidate against
Lyme disease, a severe infection which affects an increasing number
of people each year. Further data from the ongoing Phase 2 trials
in the coming months will support further dose and schedule
decisions. We are closely working with Pfizer to advance the
development of VLA15 expeditiously.”
This first Phase 2 study, conducted in the EU
and US, included 572 healthy adults aged 18 to 65 years. In the
main study phase, 452 subjects received one of two dose levels
(either 135µg or 180µg) of VLA15 (approximately 180 subjects each)
in three injections (Days 1, 29 and 57) or placebo (approximately
90 subjects). Immunogenicity was measured by determining IgG
antibodies against each of the six most prevalent Outer Surface
Protein A serotypes of Lyme borreliosis in the US and Europe
covered by the vaccine. The endpoint readout was immunogenicity at
Day 85 (one month after finalization of primary
immunization).Valneva expects to report top-line results for the
second Phase 2 study, VLA15-202, in a few months. In the VLA15-202
study, identical doses to the VLA15-201 study were tested using a
longer vaccination schedule (Days 1, 57 and 180).
About VLA 15VLA15 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 and Phase 1 studies.
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 Phase 2 Clinical Study
VLA15-201 VLA15-201, the first of two parallel Phase 2
studies, is a randomized, observer-blind, placebo controlled study
conducted in the US and Europe. In a run-in Phase of the study, 120
subjects received one of three dosage levels of VLA15, or placebo.
Following a positive review of safety data by an independent Data
Safety Monitoring Board, 452 subjects received, in the main study
phase, one of two selected dose levels of VLA15 (approximately 180
subjects each), or placebo (approximately 90 subjects).VLA15 was
tested as an alum-adjuvanted formulation and administered
intramuscularly in three injections, given at Days 1, 29 and 57.
Subjects, healthy adults 18 to 65 years of age, were followed for
one year, with the main immunogenicity readout at Day 85 (Primary
endpoint). Study centers for this study were located in areas where
Lyme disease is endemic; subjects with a cleared past infection
with Borrelia burgdorferi, the bacteria that cause Lyme disease,
were also enrolled.
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 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 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 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 Valneva Receives FDA Fast Track Designation for its Lyme
Disease Vaccine Candidate VLA15
2 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/
- 2020_07_22_VLA15-201_Initial_Phase2_Results_EN_Final