-- 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) -- 
https://www.globenewswire.com/Tracker?data=8nnSYOwH8yOAVR2Yo6ssJ8Ij_kut51HzTwWCSiEzIDDqan7CnNgr07K0u4koRSzOzh0yVxVZgYD1Rki1MqQrVQ== 
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 
https://www.globenewswire.com/Tracker?data=f6da9JxKbw3nlFVu5i1UfXoftNnHFn7ar5iEsL66mw8688NLhzKpqKp7Rg8FfNTLNeMb1f6cAMTQKNDXso9DnkPvm3Hh_-6MOOmtsdzUYGvcpAS-1IpVWg_wUi0wTarg5uTa-U8YKSjjDp6a19jEs8bgiIK4hoePt8CwuOyERDH89ogK7Zhh1bpWp7AsivqzJuq0KJGQOB1y6Zef36iMYdwBGegVf37-1quPiKc0R65s79jt0ik-w83aSUIEGeXL 
"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 (T(eff) ) 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 (T(reg) ) cells directed exquisitely 
against the antigen encoded by the mRNA vaccine. The T(reg) cells also 
executed a strong immunosuppressive bystander effect in the different MS 
mouse models, demonstrating that the T(reg) cells, once activated by 
their target antigen, can also suppress T(eff) 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, 
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TRON -- Translational Oncology at the University Medical Center of the 
Johannes Gutenberg University Mainz, the 
https://www.globenewswire.com/Tracker?data=7mz-jp20Bf1Ww3Sx9OEHf-J8wlhoHi4o42N8PyQv583iJqv6A2nzt2ZH3w8GjH3hBrSzz01nOGw2muM-6f2WNVKwwdqZMmgkKMvoE2Nh2ImWv7KXSXothdLtkCNT7eUjeJng_kmLflgRaSI_Dfaks0wkrippDL_pBF-a3fYBWL0= 
Institute for Molecular Medicine at the University Medical Center of the 
Johannes Gutenberg University Mainz and the 
https://www.globenewswire.com/Tracker?data=KkPcrX4VFjbMX_uWn-5fU8wUu09wNhSKeaarHb0AOPC_RMM9GEdNPK25YKfYwgAD5dQZ1zPMzWPf7KgOGnxATFV1RbVVYm4BSFH3uTBKQ2RUEjVg7fF5A5ev509ffRvRI1KBVmtW0Dk2aaInzXhPrg== 
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 
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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 Relations 
 
   Jasmina Alatovic 
 
   +49 89 62 81 75 46 
 
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Media@biontech.de 
 
   Investor Relations 
 
   Sylke Maas, Ph.D. 
 
   +49 (0)6131 9084 1074 
 
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Investors@biontech.de 
 
   University Medical Center Mainz Contact

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January 07, 2021 14:15 ET (19:15 GMT)