Timeline of BioNTech

This is a timeline of BioNTech, a German biotechnology company focused on immunotherapy. BioNTech is the first company to bring an mRNA-based personalized cancer vaccine to the clinic.

Sample questions

The following are some interesting questions that can be answered by reading this timeline:

• Which diseases and conditions are target of BioNTech's drug pipeline?
  • Sort the full timeline by "Disease/condition (when applicable)"
  • For the names of their respective candidate drugs, sort the full timeline by "Product research name (when applicable)".
• What are some notable research studies related to BioNTech?
  • You will mostly see research papers related by affiliation
• What are the multiple clinical trials conducted by BioNTech?
  • Sort the full timeline by "Event type" and look for the group of rows with value "Clinical trial".
  • You will mostly see trial launches, but also some sample or notable clinical trial results.
• What are some notable collaborations started between BioNTech and other organizations?
  • Sort the full timeline by "Event type" and look for the group of rows with value "Partnership".
• Who are some notable people having been related to BioNTech over the years?
  • Sort the full timeline by "Event type" and look for the group of rows with value "Team".
• What are some events describing BioNTech supply of drugs for massive administration?
  • Sort the full timeline by "Event type" and look for the group of rows with value "Supply".
  • You will see contracts of Pfizer–BioNTech COVID-19 vaccine supply by national governments.
• Other events are described under the following types: "Company launch", "Facility", "Financial", "Side effect", "Strategy", and "Team".

Big picture

Time period	Development summary	Diseases of focus	More details
2008-2012	Early period	Cancer	BioNTech is founded. Mostly research is done in this period. Almost all the research is related to cancer.
2012 onwards	RNA period	Cancer	BioNTech conducts its first trial using naked RNA in 2012, starting a period in that direction.
2020 onwards	COVID-19 period	COVID-19	BioNTech comes to the forefront after releasing the Pfizer–BioNTech COVID-19 vaccine jointly with Pfizer.

Summary per year

Year	Development summary
2008	BioNTech is founded.
2009	BioNTech acquires EUFETS and JPT Peptide Technologies.
2012	BioNTech conducts its first trial using naked RNA, in which the molecule is injected directly into lymph nodes.
2013	BioNTech becomes the first company ever, to start a fully individualized clinical program worldwide.
2014	BioNTech remains a small company, not even having its own website.
2015	BioNTech partners with Sanofi to develop up to five cancer immunotherapies, each consisting of a mixture of synthetic mRNAs.
2016	BioNTech partners with Bayer to develop a new generation of mRNA vaccines and drugs for animal health. In September of the same year, BioNTech partners with Genentech to develop an individualized mRNA tumor vaccine with a specific new etony.
2017	BioNTech publishes the application of administration of mRNA encoding an antibody as a technology for mRNA-based in vivo delivery of T cell-engaging bispecific antibodies for the potential treatment of cancer.
2018	BioNTech signs a US$425 million deal with Pfizer to develop an mRNA vaccine for influenza.
2019	BioNTech announces a US$55 million partnership with the Bill and Melinda Gates Foundation to develop new treatments for HIV/AIDS and tuberculosis. In this year, the company remains an early-stage biotech firmly focused on cancer vaccines.
2020	BioNTech is catapulted onto the world-stage with the launch of the Pfizer–BioNTech COVID-19 vaccine. The company earns €482.3 million in the year.
2021	BioNTech earns €18.9 billion in revenue alone.

Full timeline

Year	Month and date (approximately)	Disease/condition (when applicable)	Drug/product	Event type	Details
2008				Research	Study co-authored by Uğur Şahin and Özlem Türeci concludes that coupling antigens to major histocompatibility complex Class I trafficking signals increases antigen presentation efficiency.
2008				Company launch	BioNTech is founded as a "spin-off"-company of the Johannes Gutenberg University in Mainz by Uğur Şahin, Özlem Türeci, and Christoph Huber, with a seed investment of €150 million. Other co-founders include Andreas and Thomas Strüngmann, Michael Motschmann, and Helmut Jeggle.
2008	April 1	Cancer (lung)		Research	Study co-authored by Uğur Şahin on autoantibodies in lung cancer concludes that measurement of an autoantibody response to one or more tumour-associated antigens in an optimized panel assay may provide a sensitive and specific blood test to aid the early detection of lung cancer.
2008	May 1			Research	Study co-authored by Uğur Şahin and Özlem Türeci identifies protein coding gene MS4A12 (Membrane Spanning 4-Domains A12) as a colon-selective store-operated calcium channel promoting malignant cell processes.
2008	December 1	Cancer		Research	Study co-authored by Uğur Şahin and Özlem Türeci concludes that claudin protein CLDN18.2 can be qualified as a novel, highly attractive pan-cancer target for the antibody therapy of epithelial tumors.
2009	June			Acquisition	BioNTech acquires Eufets from Fresenius Biotech, retaining all facilities, staff and contracts of the former company. Eufets is a Good Manufacturing Practice (GMP) and is Good Laboratory Practice (GLP) services specialist.
2009				Research	Study co-authored by Uğur Şahin analizing the guaranteed cost control problem of fuzzy time-delay descriptor system obtains sufficient conditions for guaranteed cost controller by using Lyapunov Krasovski functional method.
2010	January 6	Cancer		Research	Study co-authored by Uğur Şahin and Özlem Türeci summarizes the current status of antigens identified for their use in cancer immunotherapy. The study highlights that cytotoxic T lymphocytes are the protagonists of an effective cytotoxic antitumoural immune response and motivates the search for antigens recognized by CD8+ T lymphocytes.
2010	November 2	Cancer		Research	Study co-authored by Uğur Şahin on intranodal vaccination with naked antigen-encoding RNA finds potent antigen-specific T-cell immunity against tumors.
2011	January 15	Cancer	Antibody	Research	Study co-authored by Uğur Şahin proves that immunization combining virus-like particles as antigen carriers with specific conformational epitopes of a highly selective differentiation antigen may elicit auto-antibodies with high cytocidal and tumoricidal potential. This result favor active immunization with virus-like particle (VLP)-based vaccines, which at the time gain increasing attention.
2012	January 11	Cancer		Research	Study co-authored by Uğur Şahin entitled Exploiting the mutanome for tumor vaccination concludes that dramatically reduced costs and time required for genome-wide discovery of cancer-specific mutations opens the door for individualized immunotherapy of cancer patients.
2012	June	Cancer (melanoma)	RBL001/RBL002	Clinical trial	BioNTech starts a clinical first-in-human dose escalation study with the purpose to evaluate the safety and tolerability of intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated antigens in patients with advanced melanoma.
2013	December	Cancer (melanoma)	IVAC MUTANOME, RBL001/RBL002	Clinical trial	BioNTech starts Phase one clinical trial with the purpose to evaluate the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma.
2014	March 13	Cancer		Research	Study co-authored by Uğur Şahin entitled Immunomic, genomic and transcriptomic characterization of CT26 colorectal carcinoma concludes that CT26 cells share molecular features with aggressive, undifferentiated, refractory human colorectal carcinoma cells. CT26 is an N-nitroso-N-methylurethane-(NNMU) induced, undifferentiated colon carcinoma cell line, which was cloned to generate the cell line designated CT26.
2014	June	Cancer (breast)	In vitro molecular diagnostic test	Research	BioNTech starts a prospective examination of RNA extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA is analyzed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper, an in vitro molecular diagnostic test.
2014	August	Cancer (breast)	MammaTyper	Clinical trial	BioNTech starts a clinical trial with the purpose to examine tumor material of a randomized number od breast cancer patients.
2014	August 22	Cancer		Research	BioNTech affiliated and Uğur Şahin co-authored study on synthesis, properties, and biological activity of boranophosphate analogs of the mRNA cap reports on a number of compounds that can potentially serve either as inhibitors of translation in cancer cells or reagents for increasing expression of therapeutic proteins in vivo from exogenous mRNAs.
2014	September 22		Engineered cell therapy	Research	Study co-authored by Uğur Şahin and Özlem Türeci reports on an approach enabling the rational development of immunotherapy strategies by providing antigen-specific T-cell receptors (TCR) and immunogenic epitopes.
2014	October 2			Facility	BioNTech and Ganymed Pharmaceuticals announce the joint- opening of a new headquarters and research facility of approximatively 10,000 square-meters in Mainz. Scientists from both companies are expected to work in a large lab on a range of pre-clinical and clinical programs mainly in the field of cancer therapies.
2014	October	Cancer (glioblastoma)	APVAC1 vaccine plus Poly-ICLC and GM-CSF, APVAC2 vaccine plus Poly-ICLC and GM-CSF	Clinical trial	BioNTech starts a clinical trial with the purpose to "assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients".
2015	March 19		Engineered cell therapy	Research	Study co-authored by Uğur Şahin describes the development of a highly versatile platform for the systematic retrieval of T-cell receptors (TCRs) from single-antigen-reactive T cells and for characterization of their function and specificity. This approach sets the stage for actively personalized immunotherapeutic strategies.
2015	March	Cancer (melanoma)	Lipo-MERIT	Clinical trial	BioNTech starts a clinical trial to evaluate a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated antigens in patients with advanced melanoma.
2015	November 26			Research	Study co-authored by Uğur Şahin explores reprogramming of human fibroblasts and Bblood-derived endothelial progenitor cells using nonmodified RNA for reprogramming and immune evasion. The study presents novel data demonstrating integration-free RNA reprogramming via co-transfection of synthetic non-modified reprogramming and vaccinia virus immune evasion mRNAs coding E3, K3 and B18R (EKB).
2016	January	Cancer (pancreatic)	MVT-5873	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate HuMab-5B1 (MVT-5873) in subjects with pancreatic cancer or other cancer antigen 19-9 (CA19-9) positive malignancies.
2016	April 22	Cancer		Research	Study co-authored by Uğur Şahin and Özlem Türeci on mutant major histocompatibility complex (MHC) class II epitopes concludes that these drive therapeutic immune responses to cancer in mice.
2016	May 10			Partnership	BioNTech partners with Bayer to develop novel, first-in-class mRNA vaccines and therapeutics specifically for animal health applications. BioNTech agrees to contribute its proprietary mRNA technology platform, formulation development capabilities, immunology expertise and intellectual property; while Bayer's Animal Health unit agrees to provide its development expertise and disease know-how. The collaboration is expected to benefit BioNTech's extensive human health program.
2016	June 16			Research	Study co-authored by Uğur Şahin and Özlem Türeci shows that RNA-LPX encoding viral or mutant neo-antigens or endogenous self-antigens induce strong effector and memory T-cell responses, and mediate potent IFNα-dependent rejection of progressive tumours.
2016	July 11	Cancer (pancreatic)	MVT-2163, MVT-5873	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor.
2016	September 21	Cancer		Partnership	BioNTech partners with American biotechnology corporation Genentech with the purpose to develop, manufacture and commercialize novel messenger RNA (mRNA)-based, individualized cancer vaccines. The collaboration aims to combine Genentech's cancer immunotherapy portfolio and research program with BioNTech's proprietary mRNA cancer vaccine technology platform, and personalized medicine expertise.
2016	October 11			Research	Study co-authored by Uğur Şahin describes the steps for translating novel RNA nanomedicines into clinical trials. The former include second generation of RNA vaccines encompassing intravenously injectable RNA nanoparticle formulations (lipoplexes), made up from lipid excipients, denoted RNA(LIP).
2016	October	Cancer (breast)	IVAC_W_bre1_uID, IVAC_M_uID	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the RNA-Immunotherapy of IVAC investigational medicinal products (IMPs) IVAC_W_bre1_uID and IVAC_M_uID. IVAC_W_bre1_uID (Antigen-targeted Personalized Breast Cancer Vaccine) is an individualized, therapeutic cancer vaccine composed of liposomes containing RNA encoding two or three tumor associated antigens that are specifically expressed in the patient's individual cancer selected "off the shelf" and p53 RNA, with potential immunostimulatory and antineoplastic activities. IVAC_M_uID is an on-demand manufactured Individualized NeoAntigen Specific Immunotherapy (iNeST) encoding neoepitopes derived from up to 20 cancer mutations determined by next-generation sequencing.
2016	October	Cancer (bladder)	NEO-PV-01	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also aims to investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. NEO-PV-01 is a personalised neoantigen-based vaccine in development by BioNTech for the treatment of cancer.
2017	April 11	HPV	HPV vaccine	Clinical trial	BioNTech starts a phase I/II vaccine dose escalation study with two different arms, one aimed to perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine, and a second aimed to perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile or cervical) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.
2017	March 9	Zika virus		Publication	BioNTech-affiliated study provides data demonstrating that lipid-nanoparticle-encapsulated nucleoside-modified mRNA elicits rapid and durable protective immunity and represents a new and promising vaccine candidate against Zika virus
2017	June 1	Cancer (pancreatic)	MVT-1075m, MVT-5873	Clinical trial	BioNTech starts a clinical trial to evaluate MVT-5873 in combination with human monoclonal antibody 5B1 (MVT-1075) in subjects with previously treated, CA19-9 positive malignancies (e.g., pancreatic adenocarcinoma). MVT-5873 is designed to kill cancer by targeting CA19-9, a protein on the surface of these pancreatic cancer cells.
2017	July 20	Cancer		Publication	Researchers at BioNTech publish study titled Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer, which demonstrates that individual mutations can be exploited, thereby opening a path to personalized immunotherapy for patients with cancer.
2017	July 23			Publication	BioNTech affiliated researchers publish study proposing that the manufacture of pharmaceutical mRNA, for being fast, could accelerate the clinical development of novel bispecific antibodies.
2017	September 6			Partnership	BioNTech announces having entered into a broad and comprehensive non-exclusive patent licensing agreement with pharmaceutical company CELLSCRIPT covering nucleoside-modified messenger RNA (mRNA) for use in all in vivo applications, including therapeutic and non-therapeutic applications in humans and animals.
2017	December 21	Cancer	Autogene cevumeran, atezolizumab	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab in participants with locally advanced or metastatic tumors.
2018	January 4			Funding	BioNTech announces having completed a US$270 million Series A round of financing, led by the Redmile Group and joined by Janus Henderson Investors, Invus, Fidelity Management & Research Company and several European family offices in addition to The Struengmann Family Office, an existing investor in BioNTech. The company is expected to use the capital to further advance its clinical pipeline of individualized immunotherapies covering a number of new approaches including mRNA and CAR-T / T-Cell receptors for the treatment of cancer and other diseases with high medical need.
2018	April 13		Antibody	Research	Study co-authored by Uğur Şahin and Özlem Türeci confirms the genetically simply transferable C-terminal polyhistidine-peptide as a general stabilizing element for chimeric HBcAg virus-like-particles to increase their suitability. Hepatitis B viral protein HBcAg is a crucial serology marker of hepatitis B infection and patient follow-up.
2018	May 4	Cancer (lung)	NEO-PV-01, pembrolizumab	Clinical trial	BioNTech starts a clinical trial to evaluate if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also aims to assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. NEO-PV-01 is a personal neoantigen vaccine of up to 20 peptides (14-35 amino acids) designed based on bioinformatic analysis of a patient’s neoantigen and human leukocyte antigen profile.
2018	May 29			Team	Özlem Türeci is appointed by BioNTech as Chief Medical Officer.
2018	July 10			Partnership	BioNTech partners with Genevant Sciences partner to develop five mRNA therapeutic programs for rare diseases with high unmet medical need. The companies also agree a series of exclusive licenses covering the application of Genevant’s delivery technology to five of BioNTech’s oncology programs.
2018	August 16			Partnership	BioNTech signs a deal with Pfizer with the purpose to develop mRNA influenza vaccines. Under the deal, Pfizer agrees to provide US$120 million in upfront and near-term payments to enter into the research and development collaboration. BioNTech is also eligible additional $305m million in potential development, regulatory and commercial milestones, as well as receiving tiered royalties on worldwide sales after the program reaches commercialization. "BioNTech signs $425m flu vaccine deal with Pfizer"
2018	September 1			Partnership	BioNTech partners with biopharmaceutical company Scancell, with the purpose to develop T-cell receptor (TCR)-based therapies. The collaboration aims to combine Scancell’s Moditope immunotherapy platform and BioNTech’s high-throughput platform for the cloning and characterization of T cell receptors.
2018	October 8	Cancer (melanoma)	NEO-PV-01	Clinical trial	BioNTech starts a clinical trial with the purpose to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma.
2018	November 5			Partnership	BioNTech partners with the University of Pennsylvania to develop nucleoside-modified mRNA vaccine. The task is appointed to Drew Weissmann’s UPenn lab with taking vaccines against up to 10 infectious diseases through to the completion of IND-enabling studies.
2018	November 28	Cancer (breast)		Clinical trial (result)	BioNTech announces new results from a clinical performance evaluation study of the CE-marked IVD MammaTyper. For this study, samples from the trial cohorts were used to validate a pre-defined score and cut-off integrating highly standardized mRNA measurements of genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67) by in vitro diagnostic test MammaTyper. The score allows the prediction of pathological complete response after neoadjuvant chemotherapy based on the pre-treatment biopsy. The cut-off accurately separates patients with a good response rate from patients with a low probability of pCR for which a different treatment than NACT or additional post-neoadjuvant treatment may be considered. Results also demonstrate that standardized measurement of ERBB2, ESR1, PGR and MKI67 mRNA is comparable to the determination of the markers on immunohistochemistry level and is strongly associated with response to neoadjuvant chemotherapy as well as long-term outcome.
2019	January 3	Cancer (metastatic neoplasm)	SAR441000	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate intratumoral administration of SAR441000 as monotherapy and in combination with cemiplimab in patients with advanced solid tumors. SAR441000 is a novel saline-formulated mixture of four mRNAs encoding interleukin-12 single chain, interferon alpha-2b, granulocyte-macrophage colony-stimulating factor, and interleukin-15 sushi that were identified as mediators of tumor regression across different murine tumor models. The candidate belongs to BioNTech's Intratumoral Immunotherapy platform.
2019	January 4			Funding	French multinational Sanofi agrees to invest €80 million (US$91 million) in BioNTech and extend its cancer collaboration with the company, as BioNTech and Sanofi prepare to start clinical development of the first cancer immunotherapy to emerge from their 2015 pact. "Sanofi Invests €80M in mRNA Cancer Vaccine Company"
2019	January 4			Strategy	BioNTech announces that the company’s shareholders have decided to convert BioNTech’s corporate legal entity from the German “AG” (Aktiengesellschaft or share-based corporation) to a European company (Societas Europaea or “SE”). This change is considered a logical step in the development of BioNTech's worldwide operations, as the company becomes a public limited company under EU law, gaining a supranational aspect. The transition enables greater flexibility to operate globally and engage in fund-raising transactions and partnerships with other international corporations.
2019	January 8	Cancer (melanoma)	RO7198457, pembrolizumab	Clinical trial	BioNTech starts a clinical trial to evaluate RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma. RO7198457 is a systemically administered RNA-Lipoplex iNeST designed to stimulate T cell responses against neoantigens.
2019	January 23			Acquisition	BioNTech announces agreement with Mab Discovery GmbH to acquire its operational antibody generation unit.
2019	April 19		Small Molecule Immunomodulator	Research	Study co-authored by Uğur Şahin and Özlem Türeci finds that systemic administration of synthetic agonist SC1 mobilizes innate and adaptive immunity and is highly potent as single agent in mice and thereby provides a rationale for clinical testing of this compound. A small molecule agonist of protein TLR7, SC1 demonstrates to stimulate natural killer cells and therefore mediates efficient immune responses, and shows an effective anti-metastatic activity in vivo.
2019	May 8		Cancer	Acquisition	BioNTech purchases MabVax Therapeutics' cancer drug assets alongside much of its infrastructure and labs with the purpose to build up a new research hub in San Diego and spread its geographic reach.
2019	May 14	Cancer	GEN1046	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety of GEN1046 as monotherapy and in combination therapies in patients with malignant solid tumors. GEN1046 is a proprietary bispecific antibody that was developed using DuoBody technology, a versatile platform technology for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer.
2019	June 17		DuoBody-PD-L1x4-1BB	Clinical trial	BioNTech starts the first-in-human Phase I/IIa study with DuoBody-PD-L1x4-1BB, the latter being a bispecific antibody in joint development with Genmab A/S, which is studied in patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy.
2019	June 23			Acquisition	BioNTech announces acquisition of MAB Discovery’s operational antibody generation unit. Under the terms of the agreement, BioNTech would acquire all assets, employees and proprietary know-how for mAb generation from MAB Discovery. MAB Discovery would retain ownership of and all rights to both its proprietary preclinical development pipeline and its existing third-party service agreements.
2019	July 9	Cancer		Funding	BioNTech raises a Series B of €289.5 million (US$325M) to develop individualized cancer vaccines. The company aims to use the money to fuel the clinical development of its lead program consisting in an individualized mRNA-based immunotherapy for treating melanoma, which completed a phase I trial in 2017. The funding is also expected to reinforce manufacturing capabilities, as well as other programs in the pipeline, including other mRNA cancer vaccines, CAR T-cell therapies, and small molecules.
2019	September 4	HIV/AIDS, tuberculosis		Partnership	BioNTech announces having signed an agreement with the Bill & Melinda Gates Foundation to develop preclinical vaccine and immunotherapy candidates to prevent HIV and tuberculosis infection as well as to lead to durable antiretroviral therapy-free remission of HIV disease. The partnership includes an initial equity investment of US$55 million, with total funding under the collaboration able to reach $100 million through potential future grant funding from the Gates Foundation.
2019	September 17	Cancer (solid tumor)	BNT 312	Clinical trial	BioNTech starts a clinical trial to evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors. GEN 1042 (also known as BNT 312) is an IgG1 Fc-silenced bispecific antibody developed by Genmab and BioNTech, for the treatment of various solid tumors.
2019	November 25	Cancer (ovarian)	W_ova1 Vaccine	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate a liposome formulated mRNA vaccine in combination with (neo-)adjuvant chemotherapy against ovarian cancer.
2019	November	Cancer (prostate)	BNT112, cemiplimab	Partnership	BioNTech signs a clinical trial supply agreement with Regeneron Pharmaceuticals to supply cemiplimab for use in combination with BioNTech’s BNT112 in a first-in-human Phase 1/2 trial in advanced prostate cancer. Regeneron agrees to supply their PD-1 checkpoint inhibitor Libtayo (cemiplimab) at no cost to BioNTech for use in combination with BNT112 in BioNTech’s planned Phase 1/2 trial. Both companies each retain full commercial rights to BNT112 and Libtayo respectively.
2019	December	Cancer, other diseases		Funding	BioNTech receives a €50 million loan, to finance the development of its patient-specific immunotherapies for the treatment of cancer and other serious diseases, from the European Investment Bank (EIB) as part of the European Commission Investment Plan for Europe.
2019	December 19	Cancer (prostate	W_pro1	Clinical trial	BioNTech starts a clinical trial to evaluate W_pro1 cancer vaccine (W_pro1) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer.
2020	January 2	Cancer (solid tumors)	CLDN6	Research	Study co-authored by Uğur Şahin introduces the developmentally regulated tight junction protein claudin 6 (CLDN6) as a chimeric antigen receptor target in solid tumors and a strategy to overcome inefficient CAR-T cell stimulation in vivo. The study demonstrates that a nanoparticulate RNA vaccine, designed for body-wide delivery of the CAR antigen into lymphoid compartments, stimulates adoptively transferred CAR-T cells. Chimeric antigen receptor (CAR)–T cells have shown efficacy in patients with B cell malignancies.
2020	March 17	COVID-19		Partnership	Biontech and Pfizer announce a partnership for COVID-19 vaccine development: Biontech is developing mRNA vaccines for COVID-19, that Pfizer will then produce at scale and distribute.
2020	March 20	COVID-19		Background	The World Health Organization declares coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1, a pandemic.
2020	April 23	COVID-19	BNT162	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety and effects of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) against COVID-2019 in healthy and immunocompromised adults.
2020	April 29	COVID-19	BNT162b1, BNT162b2	Clinical trial	BioNTech starts a clinical trial to evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate.
2020	June 19	Cancer	BNT411	Clinical trial	BioNTech starts a first-in-human (FIH) trial aiming to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. "Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411" Developed by BioNTech, BNT411 is a small molecule toll-like receptor 7 (TLR7) agonist for the treatment of solid tumors.
2020	July 20	COVID-19	BNT162b1	Supply	The Government of the United Kingdom secures 30 million doses of Pfizer–BioNTech COVID-19 vaccine.
2020	July 27			Financial	BioNTech announces the closing of its previously announced underwritten offering of 5,500,000 American Depositary Shares, each representing one of its ordinary shares, at a public offering price of $93.00 per ADS, for gross proceeds of approximately $512 million, before deducting underwriting discounts and commissions and other offering expenses payable by the company.
2020	July 28	COVID-19	BNT162b1	Clinical trial	BioNTech starts a clinical trial to evaluate the safety and immunogenicity of Pfizer–BioNTech COVID-19 vaccine in Chinese healthy subjects.
2020	July 29	Cancer (melanoma, potentially others)		Research	Study co-authored by Uğur Şahin and Özlem Türeci finds that RNA-lipoplex vaccination is a potent immunotherapy in patients with checkpoint-inhibitor-experienced melanoma, and suggests the general utility of non-mutant shared tumour antigens as targets for cancer vaccination.
2020	July 31	COVID-19	BNT162b1	Supply	Pfizer and BioNTech agree to supply Japan with 120 million doses of their COVID-19 vaccine in the first half of 2021.
2020	August 5	COVID-19	BNT162b1	Supply	Pfizer and BioNTech announce an agreement with the Government of Canada to supply their Pfizer–BioNTech COVID-19 vaccine, subject to clinical success and Health Canada approval.
2020	September 9	COVID-19	BNT162b3	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety and effects of one BNT162 vaccine against COVID-19 in healthy adults.
2020	September 16	Cancer (solid tumor)	CLDN6 CAR-T, CLDN6 RNA-LPX	Clinical trial	BioNTech starts a clinical trial to evaluate the safety and efficacy of CLDN6 CAR-T and CLDN6 RNA-LPX claudins. CLDN6 protein is a tumor-specific antigen expressed in solid tumors but silenced in adult healthy tissue during organogenesis, leading to the development of a second-generation chimeric antigen receptor T-cell product with high affinity and specificity for CLDN6.
2020	September	COVID-19	BNT162b1	Supply	The Government of Germany signs a private deal with Pfizer and BioNTech for 30 million extra doses of their vaccine. The deal is arranged outside the collective EU purchasing scheme.
2020	September 30	COVID-19	BNT162b1	Clinical trial (result)	A paper co-authored by Uğur Şahin and Özlem Türeci reports safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase I/II COVID-19 vaccine trial with BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. The vaccine is reported to elicit human antibody and T helper type 1 T cell responses.
2020	October 14	COVID-19	NT162b1, BNT162b2	Research	A study on safety and immunogenicity of BioNTech RNA-Based Covid-19 vaccine candidates BNT162b1 and BNT162b2, reports that BNT162b2 is associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. Also, "in both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples".
2020	October 21	COVID-19	BNT162b2	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety, tolerability, and immunogenicity of an RNA COVID-19 vaccine candidate BNT162b2 in healthy Japanese adults.
2020	November	COVID-19	BNT162b2	Clinical trial	Pfizer–BioNTech COVID-19 vaccine BNT162b2 enters Phase III clinical trials, with over 40,000 people participating.
2020	November 5	COVID-19	BNT162b2	Supply	The Government of Australia pre-orders 10 million doses of the Pfizer–BioNTech COVID-19 vaccine.
2020	November 11	COVID-19	BNT162b2	Supply	The European Union pre-orders 300 million doses of the BioNTech-Pfizer vaccine, at an initial price of €12 per dose. Under the agreement, the vaccine-producing pair, BioNTech and Pfizer are subject to a tightened legal obligation to bring all the experience they have gained to the European Medicines Agency for review.
2020	November 20	COVID-19	BNT162b2	Authorization (application)	BioNTech and Pfizer apply to the U.S. Food and Drug Administration for an emergency use authorization for their COVID-19 vaccine.
2020	December 1	Cancer (melanoma)	NEO-PTC-01	Clinical trial	BioNTech starts a clinical trial with the purpose to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is a personal neoantigen-targeted T cell therapy candidate derived from patients’ peripheral blood mononuclear cells and consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor.
2020	December 2	COVID-19	BNT162b2	Authorization (approval)	Pfizer–BioNTech COVID-19 vaccine becomes the first COVID‑19 vaccine to be authorized by a stringent regulatory authority for emergency use, when the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gives temporary regulatory approval. It also becomes the first cleared vaccine for regular use.
2020	December 4	COVID-19	BNT162b2	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety and immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in chinese healthy adults 18-85 years of age.
2020	December 10	COVID-19	BNT162b2	Research	A study on safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine concludes that a two-dose regimen of BNT162b2 confers 95% protection against Covid-19 in persons 16 years of age or older, while safety over a median of 2 months is found to be similar to that of other viral vaccines.
2020	December 11	COVID-19	BNT162b2	Authorization (approval)	The United States FDA grants an EUA for the Pfizer–BioNTech COVID‑19 vaccine.
2020	December 21	COVID-19	BNT162b2	Authorization (approval)	The European Medicines Agency (EMA) authorizes a one-year conditional use of the BioNTech-Pfizer vaccine in the European Union. Emer Cooke, Director of the EMA, states that the benefits of the vaccine far outweigh the potential risks.
2020	December 23	COVID-19	BNT162b2	Authorization (approval)	Argentina approves the Pfizer–BioNTech COVID-19 vaccine.
2020	December 26	COVID-19	BNT162b2	Authorization (approval)	Following the authorization, initial mass BioNTech-Pfizer vaccination against Covid-19 commences in Hungary and Slovakia.
2020	December	COVID-19	BNT162b2	Side effect	1,893,360 first doses of Pfizer–BioNTech COVID‑19 vaccine administration result in 175 cases of severe allergic reaction, of which 21 are anaphylaxis.
2021	January 7	Cancer (head and neck)	BNT113	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate mRNA vaccine candidate BNT113 in combination with pembrolizumab versus pembrolizumab alone for patients with a form of head and neck cancer positive for human papillomavirus 16 and expressing the protein PD-L1.
2021	January 8	COVID-19	BNT162b2	Supply	The European Union orders an additional 200 million doses of BioNTech-Pfizer vaccine, with an option for 100 million more.
2021	January 8	Encephalomyelitis		Research	Study co-authored by Uğur Şahin explores a noninflammatory mRNA vaccine for treatment of experimental autoimmune encephalomyelitis. The research team designed a messenger RNA vaccine strategy that lacks adjuvant activity and delivers multiple sclerosis autoantigens into lymphoid dendritic cells.
2021	January 26	Cancer	BNT151	Clinical trial	BioNTech starts a clinical trial with the purpose to assess product candidate BNT151 as a monotherapy and in combination with other agents in patients with solid tumors. BNT151 belongs to the RiboCytokines (mRNA-encoded cytokines) platform of BioNTech mRNA drug class.
2021	February 1	COVID-19	BNT162b	Research	Study co-authored by Uğur Şahin and Özlem Türeci reports that BNT162b vaccines protect rhesus macaques from SARS-CoV-2.
2021	February 8	COVID-19	BNT162b2	Research	A study supported by Pfizer and BioNTech evaluates the effect of several key spike mutations from the SARS-CoV-2 Alpha variant and SARS-CoV-2 Omicron variant strains on BNT162b2 vaccine-elicited neutralization. The results indicate small effects of these mutations on neutralization by sera elicited by two BNT162b2 doses.
2021	February 15	COVID-19	BNT162b2	Clinical trial	BioNTech starts a Phase 3 clinical trial to evaluate the safety, tolerability, and immunogenicity of multiple production lots and dose levels of BNT162b2 RNA-Based COVID-19 vaccines against COVID-19 in healthy participants.
2021	February 16	COVID-19	BNT162b2	Clinical trial	BioNTech starts a Phase 2/3, randomized, placebo-controlled, observer-blind study with the purpose to evaluate the administration of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 700 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation.
2021	March 8	Colorectal cancer	RO7198457	Clinical trial	BioNTech starts a Phase II clinical trial to compare the efficacy of mRNA-based cancer vaccine candidate RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer. RO7198457 is a systemically administered RNA-Lipoplex iNeST designed to stimulate T cell responses against neoantigens.
2021	March 24	COVID-19	BNT162b2	Clinical trial	BioNTech starts a Phase 1/2/3 clinical trial to evaluate RNA vaccine candidate BNT162b2 against COVID-19 in healthy children and young adults.
2021	March 31	COVID-19	BNT162b2	Clinical trial (result)	Pfizer and BioNTech announce the results of their Pfizer–BioNTech COVID-19 vaccine Phase 3 clinical trial in subjects aged 12 to 15, suggesting the shot is 100 per cent effective in teens. The release says the results “exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.”
2021	April 1	COVID-19	BNT162b2	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate safety, tolerability, and immunogenicity of multiple formulations of BNT162b2 against COVID-19 in healthy adults.
2021	May 10	Cancer (pancreatic)	MVT-2163, MVT-5873	Clinical trial)	BioNTech starts a clinical trial with the purpose to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer. 89Zr-DFO-HuMab-5B1 is a radioimmunoconjugate that can be used to delineate urothelial carcinomas by positron emission tomography imaging and may provide tumor-specific information prior to, during, and after systemic therapies.
2021	May 19	COVID-19	BNT162b2	Side effect	Experts commissioned by the Norwegian Medicines Agency conclude that the Pfizer-BioNTech vaccine is the likely cause of ten deaths of frail elderly patients in Norwegian nursing homes. They say that people with very short life expectancies have little to gain from vaccination, having a real risk of adverse reactions in the last days of life and of dying earlier.
2021	May 19	Cancer (melanoma)	BNT111	Clinical trial	BioNTech starts interventional clinical trial with the purpose to evaluate intravenous therapeutic cancer vaccine candidate BNT111 + cemiplimab in anti-PD-1-refractory/relapsed patients with unresectable Stage III or IV melanoma. BNT111 encodes for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation.
2021	June 8	Cancer	BNT152, BNT153	Clinical trial	BioNTech starts an interventional clinical trial with the purpose to evaluate product candidates BNT152 and BNT153 in various solid tumor indications. Both candidates belong to the RiboCytokines (mRNA-encoded cytokines) platform of BioNTech mRNA drug class.
2021	June 15	Cancer (solid tumor)	GEN1046	Clinical trial	BioNTech starts a clinical trial to evaluate proprietary bispecific antibody GEN1046.
2021	June 25	COVID-19	BNT162b2	Side effect	The US Food and Drug Administration adds a warning about the risk of rare heart inflammation (myocarditis) to the specifications of both BioNTech-Pfizer and Moderna vaccines.
2021	July 1	COVID-19	BNT162b2	Clinical trial	BioNTech starts a clinical trial to evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants in participants since 12 years of age having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
2021	July 2	Cancer (colorectal)	AdCTx	Research	BioNTech starts an epidemiological study with the purpose to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of 21 months thereafter, according to CRC stages and disease characteristics.
2021	July 12	COVID-19	BNT162b2	Supply	BioNTech announces a deal to provide Taiwan with 10 million doses of the Pfizer–BioNTech COVID-19 vaccine, with the purpose to end a serious shortage on the island.
2021	July 15	COVID-19	BNT162b2	Supply	Indonesia's Food and Drug Monitoring Agency (BPOM) grants emergency use authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine in a deal to supply 50 million doses to the country.
2021	July 26	COVID-19	BNT162b2s01, BNT162-01, BNT162-04	Clinical trial	BioNTech starts a trial to evaluate the safety and immunogenicity of one or two boosting doses of BNT162b2 or one dose of BNT162b2s01 (Variant of concern (VOC) strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants.
2021	August 18	Cancer (leukemia)	NeoVax, cyclophosphamide, pembrolizumab	Clinical trial	BioNTech starts a clinical trial with the purpose to study a novel type of vaccine as a possible treatment for chronic lymphocytic leukemia. The interventions involved in the study consist in a personalized neoantigen vaccine, poly-ICLC, cyclophosphamide, and pembrolizumab.
2021	August 23	COVID-19	BNT162b2	Authorization (approval)	The Pfizer–BioNTech COVID-19 vaccine becomes the first COVID-19 vaccine to be approved in the United States by the Food and Drug Administration for those aged sixteen years and older.
2021	August 25	COVID-19	BNT162b2	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate the safety and immunogenicity of Pfizer–BioNTech COVID-19 vaccine in healthy subjects.
2021	September 8	Cancer		Research	Study co-funded by Sanofi and BioNTech investigating local delivery of mRNA-encoded cytokines finds that it promotes antitumor immunity and tumor eradication across multiple preclinical tumor models. Having demonstrated the feasibility of intratumoral mRNA delivery, the study gives path to explore the therapeutic potential of expressing immune-modulatory proteins within the tumor.
2021	September 29	COVID-19	BNT162b2	Authorization (application)	Pfizer and BioNTech start submission of data to the US Food and Drug Administration asking for authorization of the Pfizer–BioNTech COVID-19 vaccine for children ages 5- 11 (five to 11), after considering the increased number of infections amongst children, a large number of whom having been infected since the emergence of the SARS-CoV-2 Delta variant.
2021	October 15	COVID-19	BNT162b2	Clinical trial	BioNTech launches an interventional clinical trial with the purpose to evaluate BNT162b2 in immunocompromised participants two years and older.
2021	October 27	Cancer (lung)	GEN1046	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate GEN1046 as a single agent or in combination with another anti-cancer therapy for treatment of recurrent (non-small cell) lung cancer.
2021	November 10	COVID-19	BNT162b2	Recommendation	Germany's Standing Committee on Vaccination (STIKO) recommends that only the Pfizer–BioNTech COVID-19 vaccine should be given to people under the age of 30.
2021	November 15			Facility	BioNTech announces agreement with Senegal and Rwanda for the construction of the company’s first start-to-finish factories to make messenger RNA vaccines in Africa.
2021	November	COVID-19	BNT162b2	Research	The full nucleotide sequences of the AstraZeneca and Pfizer/BioNTech vaccines are released by the United Kingdom Medicines and Healthcare Products Regulatory Agency, in response to a freedom of information request.
2021	November 29	COVID-19	BNT162b2	Product launch	Biontech announces the development of an adapted vaccine, aimed to serve as a precautionary measure while simultaneously carrying out research on the nature of the new SARS-CoV-2 Omicron variant.
2021	December 20	COVID-19	BNT162b2	Notable comment	Uğur Şahin says vaccines alone are not enough to fight SARS-CoV-2 Omicron variant, warning that other preventative measures need to be in place to stop the spread of the virus, especially with the emergence of the contagious variant.
2021	December 22	COVID-19	BNT162b2	Authorization (approval)	United Kingdom Medicines and Healthcare products Regulatory Agency approves use of Pfizer–BioNTech COVID-19 vaccine in 5 to 11-year olds, after finding that it is safe and effective.
2021	November 29	COVID-19	BNT162b2	Authorization (approval)	Taiwan's Ministry of Health and Welfare’s Advisory Committee for Immunization Practices (ACIP) approves second dose of the Pfizer–BioNTech COVID-19 vaccine for ages 12-17 and third dose for adults.
2021	December 23	COVID-19	BNT162b2	Recommendation	Hong Kong advisory panel recommends booster jab for those fully inoculated with the Pfizer–BioNTech COVID-19 vaccine. The government panel states that booster shots should been administered even if individuals are not among high-risk groups, as the SARS-CoV-2 Omicron variant by then accounts for about 80 per cent of imported infections.
2022	January 5	Shingles		Pipeline	BioNTech and Pfizer announce development of an mRNA-based vaccine for viral infection shingles, collaborating for the third time after the success of their COVID-19 vaccine based on the same technology. The vaccine would combine Pfizer's antigen technology and BioNTech's Messenger RNA platform technology.
2022	January 6	COVID-19	BNT162b2	Recommendation	The US Centers for Disease Control and Prevention updates its recommendations for the Pfizer–BioNTech COVID-19 vaccine booster to include children as young as 12, at least five months after they finish the primary vaccine series.
2022	January 7	COVID-19	BNT162b2	Research	A study comparing Pfizer–BioNTech vaccine with Moderna's mRNA-1273 COVID-19 vaccine, suggests that concerning SARS-CoV-2 infection, hospitalization and death, the mRNA-1273 vaccine shows higher efficacy compared to the BNT162b2 vaccine.
2022	January 10			Partnership	BioNTech announces partnership with biopharmaceutical company Crescendo Biologics to develop multi-specific precision immunotherapies. BioNTech agrees to pay US$40 million upfront and promise up to $750 million in milestones for multiple programs. The initial term of the discovery collaboration is three years.
2022	January 11	COVID-19		Partnership	BioNTech announces partnership with British AI-powered decision-making systemsprovider InstaDeep to develop a computational method that analyzes global sequencing data. Called the Early Warning System (EWS), it combines spike protein structural modeling with artificial intelligence algorithms to quickly flag potential high-risk COVID-19 variants.
2022	January 12	COVID-19	BNT162b2	Recommendation	Hong Kong’s vaccine advisory panel recommends giving a partial dose of Pfizer–BioNTech COVID-19 vaccine to younger children, resorting to an “off-label use” amid supply shortages for a pediatric formulation.
2022	January 18	Cancer	BNT141	Clinical trial	BioNTech starts a clinical trial with the purpose to evaluate mRNA encoded antibody therapeutic candidate BNT141, developed by the company for the treatment of solid tumors.
2022	April	Cancer (non-small-cell lung carcinoma)	BNT116	Clinical trial	BioNTech starts a first-in-human (FIH) trial for BNT116 aiming to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab or in combination with docetaxel in patients with advanced or metastasized non-small cell lung cancer (NSCLC).

Numerical and visual data

Google Trends

The chart below shows Google Trends data for BioNTech SE, from January 2009 to January 2022, when the screenshot was taken. Interest is also ranked by country and displayed on world map. The first notable increase on the chart (March 2020) is when BioNTech and Pfizer announce a COVID-19 vaccine partnership, and the second increase (October 2020) is after the success of human clinical trials. Since then, the fluctuation in interest has tracked the progress of the COVID-19 pandemic.

Google Finance

The image below shows BioNTech stock valuation in USD from IPO to January 14, 2022, when the screenshot was taken.

Meta information on the timeline

How the timeline was built

The initial version of the timeline was written by Sebastian.

Funding information for this timeline is available.

Feedback and comments

Feedback for the timeline can be provided at the following places:

• FIXME

What the timeline is still missing

• List of COVID-19 vaccine authorizations
• [1] (clinical trials)
• [2] Ref name:
• [[3]]
• Pfizer–BioNTech COVID-19 vaccine
• [4]
• [5]

See also

• Timeline of Moderna
• Timeline of mRNA research