BioNTech

BioNTech is a German biotechnology company based in Mainz, Germany.

BioNTech was founded in 2008 by Ugur Sahin, Christoph Huber and Özlem Türeci with a seed investment of €150 million from the Strüngmann family, through its investment vehicle AT Impf, and MIG Capital.¹⁾

In August 2018, BioNTech announced that it had entered a “multi-year research and development (R&D) collaboration with Pfizer” to “develop mRNA-based vaccines for prevention of influenza (flu).”²⁾ Under the terms of the agreement, following BioNTech's completion of a first-in-human clinical study, Pfizer would assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines. BioNTech received $120 million upfront.

In September 2019, BioNTech received a capital contribution of $55 million from the Bill & Melinda Gates Foundation, with the option of doubling that investment amount at a later date.³⁾

On October 16, 2019, Nature published an article describing BioNTech's successes in testing experimental immunotherapy vaccines for cancer, and suggested the progress could be applied to solve problems like rabies and pandemic influenza.⁴⁾

On March 16, 2020, BioNTech announced its receipt of a $135 million investment from Fosun Pharma in exchange for 1.58 million shares in BioNTech and the future development and marketing rights of the mRNA vaccine BNT162b2 in China.⁵⁾ Also, BioNTech announced a collaboration with Pfizer to scale-up manufacturing capacity to provide worldwide supply in response to the pandemic. BioNTech and Pfizer would commercialize the vaccine worldwide except in China, which was already covered by BioNTech's agreement with Fosun.⁶⁾

BioNTech has products in various stages of development in partnership with:⁷⁾

• Bayer
• Eli Lilly
• Genentech
• Genevant Sciences
• Genmab
• Pfizer
• Sanofi
• Translational Oncology at the University Medical Center of Johannes Gutenberg University (TRON)
• University of Pennsylvania

BioNTech has raised $1.7B in 9 rounds of investments since around 2008.⁸⁾ Investors include:^{9) 10) 11)}

• AT Impf
• Athena Capital
• Bill & Melinda Gates Foundation
• BioVeda China Fund (BVCF)
• European Investment Bank
• Fidelity
• Fosun Pharma
• German Federal Ministry of Education and Research (BMBF)
• Invus
• Janus Henderson Investors
• Jebsen Capital
• MIG Capital
• Mirae Asset Financial Group
• Platinum Asset Management
• Redmile Group
• Sanofi
• Temasek Holdings

• Wikipedia

Everything below this line needs to be cleaned up.

Definitions COVID Vaccine - Investigational medicinal product¹²⁾

Deluxe CV bios for all ¹³⁾

Sponsor trial sign off ¹⁴⁾

sponsor personnel ¹⁵⁾

Dr Stephen Thomas MD study ¹⁶⁾

coordinating ¹⁷⁾

BNT162-01 Page 1 of 1 Version: 2.0 Date: 26 Nov 2020 ¹⁸⁾

List of sponsor personnel who materially affected the trial conduct The following table presents a list of sponsor personnel who materially affected the trial conduct. The full list of all involved sponsor personnel is maintained in the trial master file ¹⁹⁾

• Name Role
• Özlem Türeci, MD Chief Medical Officer (Sponsor’s medically qualified person) b
• Svetlana Shpyro, MD Medical Expert
• Dr. Stefan Liebscher Biostatistician (External BioNTech Consultant)
• Sean Murphy Biostatistician (External BioNTech Consultant)
• Dr. Christopher Marshallsay Head Scientific-Medical Writing a
• Dr. Frans van Huizen Senior Scientific / Medical Writer
• Dr. David Langer Clinical Study Manager
• Dr. Stefanie Bolte Clinical Study Manager
• Martin Bexon, MD Medical Monitor (External BioNTech Consultant)
• Amélie Caneparo Pharmacovigilance Manager
• Claudia Müller Clinical Data Manager (External BioNTech Consultant)
• Dr. Tania Palanche Senior Clinical Data Manager

a) Document owner fulfills the requirements of the author according to ICH E3.

b) Corresponds to the medical officer defined in ICH E3. ²⁰⁾

Random sample - vaccine dates are squished together above dose type BNT162b2 or Placebo. ²¹⁾

BioNTech RNA Pharmaceuticals GmbH / Tables - 6. Snapshot All TLFs Final 1.0 BNT162b1 BNT162-01 Created on 20NOV2020 Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut-off: 23OCT2020. Table 14.3.1-3.2.2-1: Frequency of subjects with TEAEs related to IMP by SOC and PT - BNT162b1

NOTE - Influenza like illness

pdf page 512/2151²²⁾

page 140/2151 - REFERENCES²³⁾ Boraschi D, Del Giudice G, Dutel C, et al. Ageing and immunity: addressing immune senescence to ensure healthy ageing. Vaccine 2010; 28(21): 3627-31.

Destexhe E, Prinsen MK, van Schöll I, et al. Evaluation of C-reactive protein as an inflammatory biomarker in rabbits for vaccine nonclinical safety studies. J Pharmacol

Toxico. Methods 2013; 68: 367-73.

Doener F, Hong HS, Meyer I, et al. RNA-based adjuvant CV8102 enhances the immunogenicity of a licensed rabies vaccine in a first-in-human trial. Vaccine 2019; 37: 1819-26.

Kamphuis E, Junt T, Waibler Z, et al. Type I interferons directly regulate lymphocyte recirculation and cause transient blood lymphopenia. Blood 2006; 108: 3253-61.

Mulligan M, Lyke KE, Kitchinet N, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 2020; 586(7830): 589-93.

Taylor DN, Treanor JJ, Sheldon EA, et al. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine 2012; 30: 5761-9.

Tsai MY, Hanson NQ, Straka RJ, et al. Effect of influenza vaccine on markers of inflammation and lipid profile. J Lab Clin Med. 2005; 145: 323-7.

US FDA Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.

Walsh EE, Frenck R, Falsey AR, et al. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N Engl J Med. 2020; 383(25): 2439-50.²⁴⁾

^{25) 26)}

²⁷⁾

Dr. Paul Alexander May 2, 2022 ²⁸⁾ Judicial Watch FOIA - Pfizer/BioNTech Study Found Lipid Nanoparticles Materials Outside Injection Site in Test Animals; MATCHES the Japanese biodistribution findings

The Pfizer records include a report, which was approved in February 2021, on the animal trials on the distribution of the Pfizer COVID vaccine in rat subjects, in a section titled “Safety Pharmacology,” the report notes, “No safety pharmacology studies were conducted with BNT162b2 [the BioNTech vaccine] as they are not considered necessary for the development of vaccines according to the WHO guideline (WHO, 2005).” Similarly, under “Pharmacodynamic Drug Interactions,” is “Nonclinical studies evaluating pharmacodynamic drug interactions with BNT162b2 were not conducted as they are generally not considered necessary to support development and licensure of vaccine products for infectious diseases (WHO, 2005).”…

This Pfizer report notes that when lipid nanoparticles (LNPs) “with a comparable composition,” to that used in the Pfizer COVID vaccine were injected into rats, “Total recovery (% of injected dose) of LNP outside the injection site was greatest in the liver and was much less in the spleen, adrenal glands, and ovaries.” … “in summary” … “the LNP distributes to the liver.” In the detailed analysis, the report states, “Over 48 hours, the LNP distributed mainly to liver, adrenal glands, spleen and ovaries, with maximum concentrations observed at 8-48 hours post-dose. Total recovery (% of injected dose) of LNP, for combined male and female animals, outside of the injection site was greatest in the liver (up to 18%) …”…

This same Pfizer/BioNTech study notes “No genotoxicity studies are planned for BNT162b2 [the Pfizer/BioNTech COVID vaccine] as the components of the vaccine constructs are lipids and RNA and are not expected to have genotoxic potential (WHO, 2005).” Similarly, “Carcinogenicity studies with BNT162b2 have not been conducted as the components of the vaccine construct are lipids and RNA and are not expected to have carcinogenic or tumorigenic potential.”…

Also included in the Pfizer records is a report, approved in January 2021, titled “Pharmacokinetics Tabulated Summary.” A table in the report shows the biodistribution of lipid nanoparticles containing mRNA used in the vaccine using rats as the clinical trial subjects reports LNPs accumulating after 48 hours, especially in the lymph nodes, ovaries, small intestine and spleen….

a November 4, 2020, report submitted to the FDA regarding the Johnson & Johnson COVID vaccine, the authors discuss the 2007 New Zealand rabbit study in which adenovirus-vectored vaccine is trialed, but note that “No pharmacokinetic or biodistribution studies have been conducted with AD26.COV2.S specifically.”

The report notes that metabolism, excretion, and pharmacokinetic interactions with other drugs were not studied in this trial because they are “Not applicable to vaccines.” It is also noted that “biodistribution studies have not been conducted with Ad26.COV2.S.” ²⁹⁾

The Pfizer records include a report, which was approved in February 2021, on the animal trials on the distribution of the Pfizer COVID vaccine in rat subjects, in a section titled “Safety Pharmacology,” the report notes, “No safety pharmacology studies were conducted with BNT162b2 [the BioNTech vaccine] as they are not considered necessary for the development of vaccines according to the WHO guideline (WHO, 2005).” Similarly, under “Pharmacodynamic Drug Interactions,” is “Nonclinical studies evaluating pharmacodynamic drug interactions with BNT162b2 were not conducted as they are generally not considered necessary to support development and licensure of vaccine products for infectious diseases (WHO, 2005). ³⁰⁾

On the heels of Event 201 pandemic exercise Gates Foundation bet on novel gene therapy for unknown virus. The pre-pandemic investment documented below for 3.1 million shares of BioNTech purchased in Sept 2019 for $18.10/share for $55 million was worth $1.7 billion by Aug 2021.

relating to an equity investment by the BILL & MELINDA GATES FOUNDATION into BIONTECH SE

Dated: 30 August 2019 by and between

1. BioNTech SE, An der Goldgrube 12, 55131 Mainz (the Company)

and

2. Bill & Melinda Gates Foundation, a Washington charitable trust that is a tax-exempt private foundation organized and existing under the laws of Washington and having its principal place of business at 500 Fifth Avenue North, Seattle, Washington 98109, United States (the Foundation or Investor) ³¹⁾