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BioNTech SE (BNTX) is a global biotechnology pioneer advancing mRNA-based therapies for cancer and infectious diseases. This page provides investors and stakeholders with timely updates on corporate developments, clinical research milestones, and strategic initiatives shaping the future of personalized medicine.
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Bookmark this page for streamlined access to BioNTech's evolving role in oncology therapeutics and next-generation vaccine development. Regularly updated to reflect the company's scientific advancements and business strategy execution.
BioNTech has entered into a purchase agreement to acquire Kite's solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, MD. This facility will bolster BioNTech's capabilities in developing individualized cancer therapies, complementing its existing infrastructure in Germany. Kite will receive an undisclosed upfront payment. The acquisition aims to enhance BioNTech's pipeline, which includes CAR-T therapies. All Kite Gaithersburg employees will be offered employment with BioNTech, indicating a commitment to further investment in the facility.
BioNTech has commenced its Phase 2 clinical trial for cancer vaccine candidate BNT111, targeting melanoma patients who are anti-PD1-refractory. This trial follows promising Phase 1 results demonstrating a favorable safety profile and durable responses. A total of 120 patients will be enrolled across clinical sites in the EU, UK, US, and Australia. The trial evaluates the efficacy of BNT111 in combination with Libtayo, aiming for a robust immune response against cancer.
On June 10, 2021, Pfizer and BioNTech announced a deal with the U.S. government to supply 500 million doses of their COVID-19 vaccine at a not-for-profit price. The agreement includes 200 million doses in 2021 and 300 million doses in the first half of 2022, aimed at low- and middle-income countries via the COVAX Facility. This initiative is part of their commitment to provide two billion doses globally over 18 months. The deliveries will support equitable vaccine access, with production centered in U.S. facilities.
Pfizer (PFE) and BioNTech (BNTX) announced a plan to provide 500 million COVID-19 vaccine doses to the U.S. government at a not-for-profit price, aimed at supporting global vaccination efforts. This includes 200 million doses by the end of 2021 and 300 million in early 2022. The U.S. government will donate these doses to low- and lower-middle-income countries through COVAX. Pfizer and BioNTech aim to produce up to 3 billion doses in 2021, enhancing their supply chain capabilities. Deliveries will begin in August 2021.
Pfizer and BioNTech announced an expansion of the Conditional Marketing Authorization (CMA) for COMIRNATY® in the EU to include adolescents aged 12 to 15. This follows a favorable opinion from the EMA's CHMP. The CMA is now valid across all 27 EU member states. Based on a Phase 3 trial of 2,260 participants, COMIRNATY® showed 100% efficacy in this age group with a favorable safety profile. Pfizer and BioNTech also plan to submit for Emergency Use Authorization for younger age cohorts later this year.
Pfizer and BioNTech have signed a new agreement with Turkey’s Ministry of Health to supply an additional 60 million doses of their COVID-19 vaccine, bringing the total to 120 million doses for 2021. This collaboration aims to enhance Turkey’s vaccination efforts against COVID-19. The vaccine is based on BioNTech’s mRNA technology, with both companies committed to public health initiatives. CEO Ugur Sahin emphasized their goal to deliver vaccines globally to combat the pandemic effectively.
Pfizer and BioNTech announced a new agreement with the European Commission to supply 900 million doses of their COVID-19 vaccine, COMIRNATY, with an option for an additional 900 million doses. Deliveries are scheduled to begin in December 2021 and continue through 2023. This agreement brings the total commitment to 2.4 billion doses since the pandemic began. The companies emphasize the ongoing need for vaccination as COVID-19 persists and highlight their dedication to adapting the vaccine for emerging variants.
Pfizer and BioNTech have entered a new agreement with the European Commission to supply 900 million doses of the COVID-19 vaccine COMIRNATY® to the EU, with an optional additional 900 million doses. This follows a prior commitment of 600 million doses for 2021. Deliveries are set to start in December 2021 and continue into 2023, potentially totaling 2.4 billion doses. Both companies emphasize the importance of ongoing vaccinations due to the continued spread of COVID-19 and are committed to adapting their vaccine for emerging variants.
BioNTech announced the appointment of Jens Holstein as the new Chief Financial Officer (CFO), effective July 1, 2021. Holstein brings over 25 years of experience in the pharmaceutical sector, previously serving as CFO at MorphoSys AG. This transition allows Sierk Poetting, the current CFO, to concentrate on his role as Chief Operating Officer (COO). Under Poetting's leadership, BioNTech expanded significantly, growing from 300 to over 2,000 employees. The company aims to leverage Holstein's expertise to accelerate its research pipeline and bolster its global manufacturing capabilities.
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