Articles from BioNTech SE

MAINZ, Germany, January 14, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today will present its 2025 strategic priorities and progress on the Company’s pipeline of mRNA therapeutics, immunomodulators, and targeted therapies at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

MAINZ, Germany, November 13, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Biotheus (“Biotheus”) today announced the signing of a definitive agreement for the acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases.

Conference call and webcast scheduled for November 4, 2024, at 8:00 a.m. EST (2:00 p.m. CET)

MAINZ, Germany, October 31, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), will host an edition of the Company’s Innovation Series R&D Day at 10:30 a.m. Eastern Standard Time (16:30 p.m. CET) on Thursday, November 14, 2024 in New York City, U.S.

MAINZ, Germany, October 21, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2024 on Monday, November 4, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

LONDON, United Kingdom, October 1, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), alongside its artificial intelligence (“AI”) subsidiary InstaDeep Ltd. (“InstaDeep”), today presents an overview of its AI approach during an edition of the Company’s Innovation Series, AI Day.

MAINZ, Germany, September 17, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”), alongside its artificial intelligence (“AI”) company InstaDeep Ltd. (“InstaDeep”), will host an AI Day, an edition of BioNTech’s “Innovation Series”, at 09:00 a.m. EDT (3:00 p.m. CEST) on Tuesday, October 1st, 2024 in London, United Kingdom. The event will provide an overview of BioNTech’s and InstaDeep’s AI strategy and capabilities, and the application of AI in BioNTech’s pipeline and internal processes.

MAINZ, Germany, September 05, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology (“ESMO”) Congress 2024 in Barcelona, Spain from September 13-17, 2024. The oral and poster presentations will feature programs across BioNTech’s clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches.

NEW YORK and MAINZ, GERMANY, August 22, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.

NEW YORK and MAINZ, Germany, August 16, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met. In a separate Phase 2 trial, Pfizer evaluated trivalent (“tIRV”) influenza mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age. The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.  

Conference call and webcast scheduled for August 5, 2024, at 8:00 a.m. EDT (2:00 p.m. CEST)

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being developed by Regeneron, and assesses the two single agents alone.

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

NEW YORK and MAINZ, Germany, June 27, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.” 1, 2

MAINZ, Germany and SHANGHAI, China, June 24, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens. BNT324/DB-1311 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the transmembrane glycoprotein B7-H3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. The candidate is currently being evaluated in an ongoing Phase 1/2 study (NCT05914116) in patients with advanced solid tumors.

COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 — Genmab A/S (Nasdaq: GMAB, “Genmab”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced initial data from the ongoing Phase 2 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L(1)-positive metastatic non-small cell lung cancer (“mNSCLC”) who had disease progression following one or more prior lines of anti-PD(L)1-containing treatment. The results showed a 12-month overall survival (“OS”) rate of 69%, a median overall survival (“mOS”) of 17.5 months, and a 30% overall response rate (“ORR”) (confirmed ORR 17%) at the time of data cut-off in patients treated with the combination of acasunlimab and pembrolizumab every six weeks. The findings were presented at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting held in Chicago, IL from May 31-June 4, 2024.

MAINZ, Germany/OSLO, Norway, May 29, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) and the Coalition for Epidemic Preparedness Innovations (“CEPI”) are expanding their strategic partnership to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem. CEPI is committing up to US $145 million1 to support BioNTech to establish mRNA vaccine R&D, clinical and commercial-scale manufacturing capabilities at the Company’s facility in Kigali, Rwanda. These capabilities will contribute to efforts to better prepare for potential future epidemic and pandemic threats in Africa.

MAINZ, Germany, May 21, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected programs from the Company’s diversified immuno-oncology pipeline at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024. Moreover, in support of the Company’s ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in the Company’s respective clinical programs.

MAINZ, Germany, May 17, 2024 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) held its Annual General Meeting (“AGM”) today, May 17, 2024. A total of 87.51 per cent of the share capital was represented at the virtual assembly. There were 14 items on the agenda of the AGM. All resolutions proposed on the agenda items put to the vote at today’s AGM were approved by a large majority of the shareholders.

Conference call and webcast scheduled for May 6, 2024, at 8:00 a.m. EDT (2:00 p.m. CEST)

MAINZ, Germany, April 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2024 on Monday, May 6, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

MAINZ, Germany, April 7, 2024 - BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (also known as BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma (“PDAC”). The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders.

 

Mainz, Germany, March 20, 2024 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that the Supervisory Board has appointed Annemarie Hanekamp to the Management Board as Chief Commercial Officer effective July 1, 2024. She will join BioNTech from Novartis AG (“Novartis”) and succeed Sean Marett in this role.

MAINZ, Germany, March 11, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024. The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate (“ADC”) approaches.

Mainz, Germany, March 7, 2024 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that Sean Marett, Chief Business and Commercial Officer, will retire as planned from the Management Board of BioNTech. As of July 1, 2024, Sean Marett will continue as a specialist advisor to the Company at least until the end of the year. A new Chief Commercial Officer will be announced by the end of March 2024. Sean Marett’s responsibilities as Chief Business Officer are beeing gradually transferred to James Ryan, Ph.D., Chief Legal Officer, who will also take on the role of Chief Business Officer of BioNTech at the end of the transition phase and upon Sean Marett’s retirement.

MAINZ, Germany, March 6, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2023 on Wednesday, March 20, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

MAINZ, Germany and LONDON, United Kingdom, February 8, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, “Autolus”), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

 

MAINZ, Germany and SHANGHAI, China, January 22, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the first patient with metastatic breast cancer has been treated in a pivotal Phase 3 trial evaluating the efficacy and safety of the next-generation antibody-drug conjugate (“ADC”) candidate BNT323/DB-1303 targeting the Human Epidermal Growth Factor Receptor 2 (“HER2”), a cancer cell surface protein.

Mainz, Germany, January 9, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) provided its full year 2024 revenue guidance as part of its outlined 2024 strategic priorities today at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

MAINZ, Germany and SHANGHAI, China, December 21, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. BNT323/DB-1303 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the Human Epidermal Growth Factor Receptor 2 (“HER2”), a cell surface protein which is expressed in a range of tumor types. The designation is based on encouraging topline data from a Phase 1/2 study (NCT05150691) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.

KIGALI, Rwanda, December 18, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) has reached the next milestone in the establishment of mRNA vaccine manufacturing capacities in Africa with the inauguration of the Company’s site in Kigali, Rwanda. The inauguration takes place on the occasion of the set-up of the first manufacturing unit called BioNTainer. This effort is one of BioNTech’s multiple initiatives aimed at helping to build a sustainable and resilient African vaccine ecosystem and supporting equitable access to novel medicines globally: these cover research and development, clinical trials, manufacturing and local training of specialized personnel.

MAINZ, Germany, December 12, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will inaugurate its first African site in Kigali, Rwanda, on Monday, December 18th, 2023. The inauguration takes place on the occasion of the set-up of the containers for the first manufacturing unit called BioNTainer.

Conference call and webcast scheduled for November 6, 2023, at 8:00 am ET (2:00 pm CET)

NEW YORK and MAINZ, GERMANY, October 26, 2023 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced positive topline results from a Phase 1/2 study (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.

MAINZ, Germany, October 23, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced follow-up data from its ongoing first-in-human Phase 1/2 trial (NCT04503278; 2019-004323-20) evaluating the safety and efficacy of the Company’s Claudin-6 (CLDN6)-directed CAR-T cell therapy candidate BNT211 in patients with CLDN6-positive refractory/relapsed solid tumors. The data show encouraging signs of clinical activity and an increased persistence of cancer-specific CAR-T cells when combined with CARVac. At the ESMO Congress 2023 in Madrid, Prof. John Haanen, M.D., Ph.D., Netherlands Cancer Institute (NKI), Amsterdam, Netherlands presented the data in an oral late-breaking data session which confirms the positive interim data presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

MAINZ, Germany, October 23, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2023 on Monday, November 6th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2023.

MAINZ, Germany, October 19, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that the first patient has been treated in a Phase 2 clinical trial evaluating the mRNA-based individualized neoantigen-specific immunotherapy (iNeST) candidate autogene cevumeran (also known as BNT122, RO7198457) in resected pancreatic ductal adenocarcinoma (PDAC). PDACs are solid tumors with a poor prognosis reflected in a 5-year overall survival rate of only 8-10%1,2, high recurrence rates3 and limited treatment options.

MAINZ, Germany, October 16, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present data across its oncology pipeline, covering multiple solid tumor types and novel mechanisms of action, at the European Society for Molecular Oncology (“ESMO”) Congress 2023 in Madrid, Spain from October 20-24, 2023. The updates will feature oral and poster presentations for five candidates of BioNTech’s clinical pipeline across the Company’s drug classes, which comprise mRNA-based immunotherapies, cell therapies, protein-based therapeutics, and small molecules.

MAINZ, Germany, October 16, 2023 (GLOBE NEWSWIRE) -- On October 13, 2023, Pfizer Inc. (NYSE: PFE, “Pfizer”), a collaboration partner of BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), announced a non-cash charge for inventory write-offs and other charges related to COMIRNATY of $0.9 billion. The Company has been informed by Pfizer that the majority of the write-offs relate to raw materials, mainly formulation-related lipids, purchased during the pandemic, as well as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk. According to Pfizer, the write-offs do not address Pfizer-BioNTech COVID-19 Vaccine doses adapted to the XBB.1.5 variant, which has been approved and is being marketed in key geographies. 

KIRKLAND, QUEBEC and MAINZ, GERMANY, September 28, 2023 — Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that Health Canada has authorized the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) for ages 6 months and older. The updated vaccine will be available in Canada as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. For children 6 months through 4 years of age the updated vaccine is authorized for administration as a three-dose series in those without a history of completion of a COVID-19 primary vaccination course, or as a single dose for those with a history of completion of a COVID-19 primary vaccination course.

MAINZ, Germany, and OSLO, Norway, September 18, 2023 — BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox (formerly monkeypox, caused by a member of the Orthopoxvirus viral family), an infectious disease that can lead to severe, life-threatening complications. Mpox gained global attention in May 2022 with an increasing number of cases that then developed into an international outbreak.1,2 CEPI will provide funding of up to $90 million to support the development of mRNA-based vaccine candidates.

NEW YORK and MAINZ, Germany, August 30, 2023 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. The Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.

MAINZ, Germany, August 14, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced that the Supervisory Board has appointed James Ryan, Ph.D., to the Management Board as Chief Legal Officer (CLO), effective September 1, 2023. As part of the Management Board, James Ryan will continue to lead the Company’s corporate legal strategy and global legal operations including transactions, corporate governance, securities, intellectual property (IP), insurance, data privacy, among others. Prior to his appointment to the Management Board, James Ryan served as the Company’s General Counsel and Senior Vice President Legal & IP. 

Conference call and webcast scheduled for August 7, 2023, at 8:00 am EDT (2:00 pm CEST)

MAINZ, Germany, July 31, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today the completion of the acquisition of InstaDeep Ltd. (“InstaDeep”), a leading global technology company in the field of artificial intelligence (“AI”) and machine learning (“ML”). The acquisition was announced on January 10, 2023 and follows a track record of increasing collaboration between the two companies since 2019 as well as BioNTech’s initial equity investment as part of InstaDeep’s Series B financing round in January 2022.

MAINZ, Germany, July 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2023 on Monday, August 7th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2023. 

MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 29, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024.

MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 2, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), today announced positive preliminary data from the ongoing Phase 1/2 trial with the companies’ anti-CTLA-4 antibody candidate, BNT316/ONC-392 (gotistobart), in a patient cohort with metastatic, PD-(L)1-resistant non-small cell lung cancer (“NSCLC”). The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. The data will be presented in a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting by Kai He, M.D., Ph.D., Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio, USA.

Conference call and webcast scheduled for May 8, 2023, at 8:00 am EDT (2:00 pm CEST)

MAINZ, Germany, April 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2023 on Monday, May 8th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2023.

MAINZ, Germany and SHANGHAI, China, April 3, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), a clinical-stage biotech company focusing on the discovery and development of next generation antibody-drug conjugate (“ADC”) therapeutics to treat patients with cancer and autoimmune diseases, today announced that the companies have entered into exclusive license and collaboration agreements for two ADC assets to develop, manufacture and commercialize the two assets globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. With this collaboration, ADCs will become an additional drug class in BioNTech’s oncology portfolio with the aim to further support BioNTech’s mission of developing highly efficacious therapies for cancer patients at every stage of disease.

MAINZ, Germany, March 28, 2023 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) today announced that it has entered into a new share repurchase program (the “Program”), pursuant to which the Company may purchase American Depositary Shares, each representing one ordinary share (“ADS”), of the Company in the amount of up to $0.5 billion during the remainder of 2023. BioNTech expects to use all or a portion of the repurchased ADSs and the ADSs held in treasury to satisfy upcoming settlement obligations under the Company’s share-based payment arrangements. 

Conference call and webcast scheduled for March 27 at 8:00 am ET (2:00 pm CET)

MAINZ, Germany and ROCKVILLE, Maryland, USA, March 20, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel biologicals for cancer treatment, today announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

MAINZ, Germany, March 13, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2022 on Monday, March 27th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2022. 

JERUSALEM, Israel, March 1, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) announced that the Company and the Weizmann Institute of Science (“Weizmann Institute”) signed a Memorandum of Understanding (MoU). As part of this MoU, scientists from a variety of disciplines from BioNTech and the Weizmann Institute will collaborate in basic and applied research with the aim to better understand various diseases, including cancer, infectious diseases, and neurodegenerative diseases. The joint research will be conducted at BioNTech’s newly established mRNA Excellence Center and in Weizmann Institute laboratories.   

MAINZ, Germany, February 2, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced construction completion of the Company’s first proprietary plasmid DNA manufacturing facility in Marburg, Germany. Plasmid DNA is an important starting material for the manufacturing of mRNA-based vaccines and therapies, as well as cell therapies. With the new facility, BioNTech plans to independently manufacture plasmid DNA for clinical product candidates and commercial products in the areas of cancer and infectious diseases. German Chancellor Olaf Scholz is visiting the new manufacturing facility in Marburg today together with BioNTech co-founders Prof. Ugur Sahin, M.D., Chief Executive Officer, and Prof. Özlem Türeci, M.D., Chief Medical Officer. 

MAINZ, Germany, and LONDON, United Kingdom, January 10, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and InstaDeep Ltd. (“InstaDeep”) today announced that they have entered into an agreement under which BioNTech will acquire InstaDeep, a leading global technology company in the field of artificial intelligence (“AI”) and machine learning (“ML”). The transaction includes a total upfront consideration of approximately £362 million in cash and BioNTech shares to acquire 100% of the remaining InstaDeep shares, excluding the shares already owned by BioNTech. In addition, InstaDeep shareholders will be eligible to receive additional performance-based future milestone payments up to approximately £200 million. The transaction follows BioNTech’s initial equity investment as part of InstaDeep’s Series B financing round in January 2022.

MAINZ, Germany, January 6, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) today announced that the Company signed a Memorandum of Understanding (“MoU”) with the Government of the United Kingdom (“UK”) to benefit patients by accelerating clinical trials for personalized mRNA immunotherapies with the aim to provide personalized cancer therapies for up to 10,000 patients by the end of 2030, either in clinical trials or as authorized treatments. This objective is part of a multi-year collaboration focused on three strategic pillars: cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding BioNTech’s footprint in the UK as one of the Company’s key markets.

Mainz, Germany, December 28, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that CEO and Co-founder Prof. Ugur Sahin, M.D., will present a corporate overview and update at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 9:45 am PST / 12:45 pm ET.

MAINZ, Germany, December 23, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") today announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein (CSP).

MAINZ, GERMANY, and SHANGHAI, CHINA, December 22, 2022 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that the companies provided approximately 11,500 doses of mRNA-based COVID-19 vaccines which arrived  on the Chinese Mainland on December 21, 2022. The delivery contains both the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and the monovalent COVID-19 vaccine.  

MAINZ, GERMANY, December 21, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) reached the next milestone in the establishment of scalable mRNA vaccine production in Africa. The six ISO-sized shipping containers for the first BioNTainer have finished construction in Europe, underwent quality checks by BioNTech experts and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of 2023. Media material from the preparation is now available here.

MAINZ, Germany, December 21, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or the "Company”) today announced that the first subject was dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. The trial (NCT05432583) will evaluate the safety, tolerability, and immunogenicity of BNT163. The mRNA vaccine encodes three HSV-2 glycoproteins with the aim of helping to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs.

NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.1

NEW YORK and MAINZ, GERMANY, DECEMBER 8, 2022 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. Children in this age group can receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention ("CDC").

MAINZ, Germany and KRAKOW, Poland – November 30, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Ryvu Therapeutics S.A. (Warsaw Stock Exchange: RVU, “Ryvu”), a clinical-stage company developing oncology therapeutics today announced that the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu’s STING agonist portfolio as standalone small molecules.

NEW YORK and MAINZ, GERMANY, NOVEMBER 18, 2022 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an analysis examining the immune response induced by their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine [Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)] against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. These data, posted on the preprint server bioRxiv, indicate that the companies’ bivalent vaccine elicits a greater increase in neutralizing antibody titers than the companies’ original COVID-19 vaccine against these emerging Omicron sublineages. Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved protection against COVID-19 due to Omicron BA.4 and BA.5 sublineages as well as new sublineages that continue to increase in prevalence.

NEW YORK and MAINZ, GERMANY, NOVEMBER 16, 2022 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicity of a next generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against COVID-19. This candidate, BNT162b4, is composed of a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are highly conserved across a broad range of SARS-CoV-2 variants and will be evaluated in combination with the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. These non-spike proteins have been chosen based on BioNTech's proprietary target prioritization platform and were designed into a vaccine candidate with the purpose of enhancing and broadening T cell immunity and potentially extending durability of protection against COVID-19.

MAINZ, GERMANY, and SINGAPORE, November 14, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced its Singapore affiliate BioNTech Pharmaceuticals Asia Pacific Pte. Ltd. had entered into an agreement with Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. to acquire one of its GMP-certified manufacturing facilities. The acquisition is part of BioNTech’s expansion strategy to strengthen its global footprint in Asia. Supported by the Singapore Economic Development Board (“EDB”), the facility will serve as BioNTech’s Regional Headquarters and become its first mRNA manufacturing facility in Singapore.

NEW YORK and MAINZ, GERMANY, November 10, 2022 — Pfizer Inc. (NYSEPFE) and BioNTech SE (Nasdaq: BNTX) today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5-µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

Conference call and webcast scheduled for November 7, 2022, at 8:00 am ET (2:00 pm CET)