Articles from BioNTech SE

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.