Nature Medicine Reports Elimination of Large Tumors in Mice by Messenger RNA-Encoded Bispecific Anti

Nature Medicine Reports Elimination of Large Tumors in Mice by Messenger RNA-Encoded Bispecific Antibodies

ID: 547457

(Thomson Reuters ONE) -
BioNTech AG /
Nature Medicine Reports Elimination of Large Tumors in Mice by Messenger
RNA-Encoded Bispecific Antibodies
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The issuer is solely responsible for the content of this announcement.

Novel mRNA-based antibody drug class holds promise for fast development of
potent immunotherapies

MAINZ, Germany, June 12, 2017 (GLOBE NEWSWIRE) -- BioNTech AG, a fully-
integrated biotechnology company pioneering individualized cancer immunotherapy,
reported preclinical data featuring a novel class of mRNA-encoded antibody drugs
called RiboMABs®. In Nature Medicine, BioNTech presents the application of this
technology for mRNA-based in vivo delivery of T cell engaging bispecific
antibodies. The study entitled "Elimination of large tumors in mice by mRNA-
encoded bispecific antibodies" can be found
here: http://nature.com/articles/doi:10.1038/nm.4356.

Bispecific antibodies act by connecting human immune cells to tumor cells for
highly efficient killing and have demonstrated great promise as immunotherapy
agents. However, the challenges that go along with demanding procedures of
production, purification and formulation of a recombinant protein hinder the
development of new drugs in this class.

Administering the mRNA encoding the bispecific antibody, thus enabling the
patient's body to synthesize the therapeutic protein, may profoundly reduce
complexity of drug development.

BioNTech researchers achieved this aim by incorporating
modified nucleosides into the pharmacologically optimized mRNA and using liver
targeting nanoparticles to ensure prolonged production in vivo. Intravenously
injecting a few micrograms of mRNA resulted in bispecific RiboMAB production in




the liver cells that rapidly secreted into the circulation, reaching peak level
within hours and remaining at therapeutically effective plasma concentrations
for a week.

To demonstrate universality of this novel approach, bispecific RiboMABs
targeting different tumor antigens were generated, and their therapeutic potency
was tested in mice bearing human tumors and repopulated with human immune cells.
Weekly application of any of the bispecific RiboMAB, directed against cancer
antigens that are present in many human cancers, resulted in elimination of
aggressively growing, large tumors. This is the first preclinical study to
demonstrate in vivo application of mRNA-encoded antibodies for successful
treatment of cancer.

"Our data show that with low doses of mRNA encoding a bispecific antibody, we
get sustained production of RiboMAB comparable to those of naturally produced
immunoglobulin proteins and capable of curing advanced cancers in mice," said
Prof. Ugur Sahin, founder and CEO of BioNTech, who led the study. "What we have
learned about RiboMAB pharmacology provides a sound basis for moving towards
first clinical testing of this approach in cancer patients."

The extension to other antibody formats as well as to biomedical fields such as
infectious disease is conceivable especially as the feasibility to generate mRNA
encoding IgG against infectious disease has been reported very recently (Nature
Communications 8, Article number: 14630 (2017)).

About BioNTech AG

BioNTech is Europe's largest privately held biopharmaceutical company pioneering
the development of individualized therapies for cancer and other diseases. The
Company combines all building blocks for individualized immunotherapy under one
roof - from diagnostics and drug development to manufacturing. Its cutting-edge
technologies range from individualized mRNA-based medicines through innovative
chimeric antigen receptors and T-cell receptor-based products to novel
checkpoint immunomodulators. BioNTech's approach is validated by five top-tier
corporate partnerships with Genentech, Genmab, Eli Lilly and Company, Sanofi and
Bayer Animal Health. Founded in 2008, BioNTech's financial shareholders include
the MIG Fonds, Salvia and the Strüngmann Family Office, with the Strüngmann
Family Office as the majority shareholder.

More information about BioNTech is available at www.biontech.de.

For more information, please contact:

General Inquiries:
BioNTech AG
Regina Jehle
Tel: +49 6131 9084 1273
Email: Regina.Jehle(at)biontech.de

US Media & Investors:
ICR Healthcare
James Heins / Stephanie Carrington
Tel: +1 203 682 8251
Tel: +1 646 277 1282
Email: James.Heins(at)icrinc.com
Email: Stephanie.Carrington(at)icrinc.com

International Media & Investor Inquiries:
akampion
Dr. Ludger Wess / Ines-Regina Buth
Tel: +49 40 8816 5964
Tel: +49 30 2363 2768
Email: info(at)akampion.com




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Source: BioNTech AG via GlobeNewswire




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Datum: 12.06.2017 - 17:01 Uhr
Sprache: Deutsch
News-ID 547457
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