BioNTech Publishes Data on Novel mRNA Vaccine Approach to Treat Autoimmune Diseases in Science
08 January 2021 - 6:15AM
- Collaborative study of BioNTech with TRON and the University
Medical Center and Research Center for Immunotherapy at Johannes
Gutenberg University of Mainz introduces novel non-inflammatory
mRNA vaccine encoding disease-related autoantigens that suppressed
disease activity in several complex mouse models of multiple
sclerosis
- Approach addresses key pitfalls in the treatment of autoimmune
diseases such as the induction of systemic immune suppression
- Approach can easily be tailored to individual disease-causing
antigens of patients and confers bystander tolerance to address
highly complex, polyclonal and rare autoimmune disease types
- Represents the first application of BioNTech’s mRNA technology
for the purpose of antigen-specific immune-modulation of autoimmune
diseases, which further expands BioNTech’s diversified immunology
pipeline into another category of disease relevant targets
MAINZ, GERMANY, January 7, 2021 (GLOBE
NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) announced today the publication of preclinical data on
its novel mRNA vaccine approach against autoimmune diseases in the
peer-reviewed journal Science. The publication titled “A
non-inflammatory mRNA vaccine for treatment of experimental
autoimmune encephalomyelitis” summarizes the findings on the
disease-suppressing effects of a non-inflammatory,
nucleoside-modified mRNA vaccine in several clinically relevant
mouse models of multiple sclerosis (MS).
Autoimmune diseases like MS represent conditions
in which the immune system malfunctions and attacks healthy tissue
or cells of the body. In MS, the inflammation causes the
destruction of the protective myelin sheath that covers the nerve
fibers. This damage disrupts the ability to transmit signals
between nerve cells and the target tissue resulting in a range of
neurological, sensory and motor symptoms that may differ greatly
between individuals.
This first application of BioNTech’s mRNA
technology in MSs represents a new modality in this indication and
underlines BioNTech’s potential to leverage its proprietary mRNA
platform.
In the study, a non-inflammatory nanoparticulate
mRNA vaccine candidate encoding a MS-associated antigen was
systemically applied to mice with experimental autoimmune
encephalomyelitis (EAE), which represent clinically relevant mouse
models of human MS. The mRNA vaccine candidate was designed to
deliver the encoded autoimmune disease target antigen into
antigen-presenting cells in the lymph nodes body-wide in a
non-inflammatory context to enable systemic, immune
tolerance-inducing antigen presentation in lymphoid tissues.
In all investigated EAE mouse models, the
vaccine was able to prevent symptomatic disease or, in mice with
early-stage disease, reduced further disease progression and
restored motor functions. Pro-inflammatory effector T (Teff) cell
infiltration in the brain and spinal cord and demyelination of the
spinal cord was considerably reduced. These effects were achieved
via development of disease-suppressing regulatory T (Treg) cells
directed exquisitely against the antigen encoded by the mRNA
vaccine. The Treg cells also executed a strong immunosuppressive
bystander effect in the different MS mouse models, demonstrating
that the Treg cells, once activated by their target antigen, can
also suppress Teff cells against other antigens in the inflamed
tissue in a complex disease setting. This is a crucial factor to
also address polyclonal diseases based on multiple, partly unknown
antigens, as well as inter-individual heterogeneity between
patients.
Importantly, the preclinical vaccine candidate
did not suppress functional immune responses against other,
non-myelin antigens (e.g. influenza vaccine antigens), therefore
addressing one of the key challenges in autoimmune treatment in the
preclinical studies, the induction of an unspecific, systemic
immune suppression. In addition, the vaccine candidate, even after
repetitive application, did not induce formation of autoantibodies
against the targeted antigen, another potential pitfall in current
autoimmune therapies that could exacerbate disease. Overall, these
initial results regarding the immune response together with the
flexibility of the mRNA approach to target individual patient
antigens indicate the potential of mRNA therapeutics to address
highly complex and rare autoimmune disease indications.
The publication represents results of a
collaborative study of scientists from BioNTech, TRON –
Translational Oncology at the University Medical Center of the
Johannes Gutenberg University Mainz, the Institute for Molecular
Medicine at the University Medical Center of the Johannes Gutenberg
University Mainz and the Research Center for Immunotherapy (FZI) at
the Johannes Gutenberg University Mainz.
About BioNTech
Biopharmaceutical New Technologies is a next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. The Company exploits a wide array of
computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer. For more information, please visit
www.BioNTech.de.
BioNTech Forward-looking
Statements This press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to: statements concerning the applicability of
BioNTech’s mRNA technology in autoimmune diseases. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond BioNTech’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements. Any forward-looking statements in
this press release are based on BioNTech current expectations and
beliefs of future events, and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. The forward-looking statements in this
press release are neither promises nor guarantees, and you should
not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond BioNTech’s control and
which could cause actual results to differ materially from those
expressed or implied by these forward-looking statements.
For a discussion of these risks and
uncertainties, see BioNTech’s Quarterly Report for the Three and
Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its
Current Report on Form 6-K filed with the SEC on November 10, which
is available on the SEC’s website at www.sec.gov. All information
in this press release is as of the date of the release, and
BioNTech undertakes no duty to update this information unless
required by law.
BioNTech Contacts:
Media RelationsJasmina
Alatovic+49 89 62 81 75 46 Media@biontech.de
Investor RelationsSylke Maas,
Ph.D.+49 (0)6131 9084 1074Investors@biontech.de
University Medical Center Mainz
Contact Stabsstelle Unternehmenskommunikation +49 06131 17
7427pr@unimedizin-mainz.de
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