Valneva and LimmaTech Enter into a Strategic Partnership to
Accelerate the Development of the World’s Most Clinically Advanced
Tetravalent Shigella Vaccine Candidate
- Valneva obtains exclusive worldwide license for
LimmaTech’s S4V Shigella
vaccine candidate and adds an attractive Phase 2 clinical
asset to Valneva’s R&D pipeline
- LimmaTech to receive
upfront payment, is eligible for future milestone and royalty
payments, and will collaborate on S4V clinical development through
Phase 2
- Valneva will host a live webcast on this announcement
at 3 p.m. CEST/9 a.m. EDT today. Please refer to this
link: https://edge.media-server.com/mmc/p/ck932u2n
Saint-Herblain (France) and Schlieren
(Zurich), August 1, 2024 – Valneva SE (Nasdaq: VALN;
Euronext Paris: VLA), a specialty vaccine company and LimmaTech
Biologics AG, a clinical-stage biotech company developing vaccines
for the prevention of life-threatening diseases, today announced
that the companies have entered into a strategic partnership and
exclusive licensing agreement for the development, manufacturing
and commercialization of Shigella4V (S4V), a tetravalent
bioconjugate vaccine candidate against shigellosis.
Shigellosis, caused by Shigella
bacteria, is the second leading cause of fatal diarrheal disease
worldwide. It is estimated that up to 165 million cases of disease
and an estimated 600,000 deaths are attributed to Shigella
each year1, particularly among children in Low- and
Middle-Income Countries (LMICs). No approved Shigella
vaccine is currently available and the development of
Shigella vaccines has been identified as a priority by the
World Health Organization (WHO)2. Shigellosis also
affects international travelers from high-income countries and
deployed military personnel in endemic regions. The global market
for a vaccine against Shigella is estimated to exceed $500
million annually3.
Under the terms of the agreement with Valneva,
LimmaTech will receive an upfront payment of €10 million and be
eligible to receive additional regulatory, development and
sales-based milestone payments as well as low double-digit
royalties on sales. LimmaTech will be responsible for conducting a
Phase 2 Controlled Human Infection Model (CHIM) and a Phase 2
pediatric study in LMICs. Both clinical trials are expected to
begin in the second half of 2024. Valneva will assume all further
development, including CMC (chemistry, manufacturing and controls)
and regulatory activities, and be responsible for its
commercialization worldwide if approved.
Thomas Lingelbach, Chief Executive
Officer of Valneva, commented, “We are very pleased to
partner with LimmaTech to advance a promising program in an area of
high unmet medical need. The Shigella vaccine candidate
enables a potential first-in-class vaccine solution for both LMICs
and travelers and, as such, represents a potentially highly
synergistic product for Valneva. The anticipated development path
follows a staggered and risk-mitigated strategy, and hence allows
an efficient capital allocation in line with our communicated plan
of having a new R&D program in Phase 3 by 2027.”
Dr. Franz-Werner Haas, Chief Executive
Officer of LimmaTech, said, “Having
developed the S4V Shigella vaccine candidate
from its early discovery phase to the promising clinical data we
achieved to date, we are excited to accelerate the program with our
partnership with Valneva. Their proven expertise in late-stage
development and commercialization of vaccines will expedite
potential market approval and bring a Shigella vaccine to
people in need. This agreement underscores our capabilities to
leverage LimmaTech’s proficiency in vaccine development with the
best path to develop programs rapidly. We continue to expand our
pipeline of vaccine candidates to combat microbial-based infectious
diseases, providing protection against antimicrobial resistance, a
dramatically increasing global health threat.”
LimmaTech initiated the tetravalent
Shigella vaccine candidate and continued to lead its
development as part of its ongoing collaboration with GSK, and
later in-licensed the vaccine candidate from GSK. In February 2024,
LimmaTech reported positive interim Phase 1/2 data for the S4V
vaccine candidate, including a favorable safety and tolerability
profile as well as robust data on immunogenicity against the four
most common pathogenic Shigella serotypes, S.
flexneri 2a, 3a, 6, and S. sonnei4. The
results of the completed Phase 1/2 study confirmed the interim
data.
About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative
Shigella bacteria. It is estimated that up to 165 million
infections5 are due to Shigella of which 62.3
million occur in children younger than five years. Diarrheal
infection is one of the major causes of morbidity and mortality in
numerous countries as well as in travelers and deployed military
personnel in endemic regions. There are an estimated 600,000 deaths
attributed to Shigella each year and it is the second
leading cause for diarrheal deaths6. The standard
treatment for shigellosis is oral rehydration and antibiotic
therapy, however, the bacteria have acquired resistance to many
antibiotics with numerous reports of outbreaks of
multidrug-resistant strains, making treatment extremely difficult.
Currently, no licensed Shigella vaccine is available.
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines
from early R&D to approvals, and currently market three
proprietary travel vaccines, including the world’s first and only
chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our growing commercial business help fuel the
continued advancement of our vaccine pipeline. This includes the
only Lyme disease vaccine candidate in advanced clinical
development, which is partnered with Pfizer, as well as vaccine
candidates against the Zika virus and other global public health
threats. More information is available at www.valneva.com.
About LimmaTech Biologics
AG
LimmaTech Biologics is at the forefront of combating the global
antimicrobial resistance epidemic based on its unparalleled track
record in vaccine technology and clinical candidate development.
The company is leveraging its proprietary self-adjuvanting and
multi-antigen vaccine platform alongside additional
disease-specific vaccine approaches to prevent increasingly
untreatable microbial infections. With decades of expertise and an
expanding, robust pipeline, the LimmaTech team is dedicated to
generating protective solutions to deliver transformative value
worldwide. LimmaTech Biologics is backed by specialist healthcare
investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings
REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.
Contacts
For Valneva
Valneva
Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com |
For LimmaTech
LimmaTech Biologics AG
Franz-Werner Haas, CEO
E-mail: media@lmtbio.com
For media enquiries
Trophic Communications
Sara Ortiz or Jacob Verghese
Phone: +49 151 7441 6179
E-mail: limmatech@trophic.eu
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to business partnerships, the progress,
timing, results and completion of research, development and
clinical trials for product candidates, to regulatory approval of
product candidates and review of existing products. 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
and delays 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 financing environment, and the ability
to obtain or maintain patent or other proprietary intellectual
property protection. Success in preclinical studies or earlier
clinical trials may not be indicative of results in future clinical
trials. In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made in this press
release will in fact be realized. Valneva is providing this
information as of the date 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 Shigellosis | CDC Yellow Book 2024
2 Immunization, Vaccines and Biologicals
(who.int)
3 Valneva’s Initial internal assessment
4
20240221_LimmaTech_Shigella-Interim-Data-PR_Final.pdf
(lmtbio.com)
5Shigellosis | CDC Yellow Book 2024
6 Shigellosis | CDC Yellow Book 2024
- 2024_08_01_VLA_LMTB_S4V_PR_EN_Final
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