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BioNTech

BioNTech, also known as Biopharmaceutical New Technologies, is a German company that specializes in immunotherapies for serious diseases, including cancer. Their expertise in mRNA vaccine development led them to work with Pfizer to develop the COVID-19 vaccine, Comirnaty.

Last Modified: March 7, 2022
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What Kind of Company Is BioNTech?

BioNTech is a biotechnology company that specializes in creating therapies and vaccines to treat and prevent serious human disease, especially cancer.

Biotechnology is the science of using living organisms or parts of living organisms to create products. Examples of products created with biotechnology include: Medicines, genetically modified organisms for agriculture and textiles.

BioNTech focuses on messenger RNA, or mRNA — also called ribonucleic acid. Code written in mRNA delivers genetic information to cells. Along with mRNA, BioNTech uses cell therapies and antibodies to create its portfolio of individualized therapies.

“Our mission is to develop the next generation of immunotherapies to improve clinical outcomes for patients and usher in a new era of individualized medicine.”

BioNTech History

Husband and wife scientists, Ugur Sahin and Ozlem Tureci, founded BioNTech in 2008 in Mainz, Germany. Sahin is the company’s current Chief Executive Officer, and Tureci serves as its Chief Medical Officer.

Sahin and Tureci founded BioNTech with the goal of using the genetic makeup of an individual patient’s tumor to tailor a cancer treatment program for that specific patient.

In 2017, BioNTech rebranded EUFETS, its manufacturing subsidiary, to BioNTech Innovative Manufacturing Services. The new subsidiary specializes in manufacturing gene therapy products, including mRNA and viral vectors, and supplying them worldwide.

At the beginning of 2022, BioNTech had over 20 product candidates, with 10 of those in ongoing clinical trials. The company often collaborates with other pharmaceutical companies to create products. BioNTech collaborators include: Pfizer, Sanofi, Bayer Animal Health and Genentech.

Pfizer-BioNTech COVID-19 Vaccine

In January 2020, BioNTech began developing the COVID-19 vaccine that would later become Comirnaty. BioNTech scientists called the initiative Project Lightspeed. Pfizer had previously worked with BioNTech to develop a flu vaccine in 2018. In March 2020, the two companies agreed to work together to rapidly test COVID-19 vaccine candidates and commercialize the vaccine.

In December 2020, the FDA granted the Pfizer-BioNTech vaccine an Emergency Use Authorization (EUA), and in August 2021, the vaccine received full FDA approval under the brand name Comirnaty for use in individuals 16 years of age and older. It continues to be available for use under EUA for individuals 5 years of age and older.

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Clinical trials have shown Comirnaty is 95% effective at “preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two doses and had no evidence of being previously infected.”

The most common vaccine side effects include: Fever, chills, pain at the injection site, fatigue and headache. Rare but serious risks include allergic reactions, myocarditis and pericarditis — inflammation of the heart muscle and the lining of the heart. The FDA has determined that the benefits of vaccination against COVID-19 outweigh the risks.

In January 2022, Allele Biotechnology and Pharmaceuticals Inc. resolved a patent dispute lawsuit that claimed Pfizer and BioNTech misused the company’s patented florescent protein in Comirnaty’s development. The parties agreed to dismiss the claims, according to Reuters.

Key BioNTech Therapies

BioNTech builds its product portfolio on four key therapeutic areas and drug classes: mRNA, engineered cell therapies, antibodies and small molecule immunomodulators.

It’s important to note that as of February 2022, these applications are still in clinical trials.

mRNA Therapeutics
BioNTech manufactures four different mRNA formats for the treatment of cancer. Once in the body, these nRNA molecules help the body’s immune system recognize and fight tumor cells. The company is also developing nRNA technology to treat influenza and rare diseases. These include: FixVac, iNeST, Intratumoral Immunotherapy, RiboMabs and RiboCytokines.
Engineered Cell Therapies
These therapies modify the body’s T cells, immune cells that come from bone marrow, to target cancer antigens. These include: CAR-T cells and Neoantigen-based T cell therapy.
Antibodies
In collaboration with Genmab, BioNTech is developing antibodies that prime a patient’s immune system to fight cancer. The antibodies help the immune system target cancer cells. These include: Next-Gen CP Immunomodulators and Targeted Cancer Antibodies.
Small Molecule Immunomodulators
Therapies made with small molecule immunomodulatory technology can deliver toxins to cancer cells, mark cancer cells for destruction, regulate cancer growth and stop tumors from forming blood vessels. They can be taken orally and be used with chemotherapy, mRNA and radiation therapy. This includes Toll-Like Receptor Binding.

These drug classes allow more individualized treatments for cancers depending on the genetic sequence of the tumor. Some cancer treatment plans may use more than one of these therapies.

BioNTech Pipeline for Future Treatments

BioNTech has multiple drugs in oncology and infectious diseases in clinical trials. Five of these new products are in Phase II clinical trials.

BioNTech pipeline therapies in clinical trials, include:
  • FixVac for melanoma, prostate cancer, head and neck cancer and ovarian cancer
  • iNeST for melanoma, solid tumors and colorectal cancer
  • Intratumoral Immunotherapy for solid tumors
  • RiboCytokines for solid tumors
  • CAR-T cells for pancreatic and other cancers
  • Neoantigen-based T-cell therapy for solid tumors
  • Next-Gen CP Immunomodulators for solid tumors
  • Targeted Cancer Antibodies for pancreatic cancer
  • Toll-Like Receptor Binding for solid tumors
  • nRNA for influenza

In addition to more oncology offerings, BioNTech has several mRNA applications for diseases such as malaria, HIV, shingles and tuberculosis in pre-clinical development.
Most of these products are fully-owned by BioNTech, and some are in collaboration with Pfizer, Genentech, Sanofi and Genmab. Patients interested in more information about these clinical trials can visit BioNTech’s clinical trial page.

Please seek the advice of a medical professional before making health care decisions.