BIONTECH - BNTX STOCK NEWS

BioNTech signed a Memorandum of Understanding with the UK Government to enhance clinical trials for personalized cancer immunotherapies. The collaboration aims to provide treatments for up to 10,000 patients by 2030. This multi-year effort will focus on cancer immunotherapies, infectious disease vaccines, and expanding BioNTech's presence in the UK. A new R&D hub in Cambridge will employ over 70 scientists. The first patient is expected to enroll in clinical trials by H2 2023.

BioNTech (Nasdaq: BNTX) announced that CEO Prof. Ugur Sahin will present an overview at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 9:45 am PST / 12:45 pm ET. A live webcast will be available on the Company's website and will be archived for 30 days. BioNTech is a leader in immunotherapy, focused on innovative therapies for cancer and infectious diseases, leveraging cutting-edge mRNA technology. The Company collaborates with various global pharmaceutical partners to advance its diverse oncology and vaccine pipeline.

BioNTech SE has launched a Phase 1 clinical trial for its mRNA-based malaria vaccine candidate, BNT165b1. This innovative vaccine aims to combat malaria caused by Plasmodium falciparum, with a goal to select an optimal multi-antigen candidate for further development. The study will evaluate the safety and immunogenicity of BNT165b1 and will enroll around 60 healthy volunteers in the U.S. The company’s initiative aligns with the urgent need for effective malaria prevention in sub-Saharan Africa, where malaria remains a significant health threat.

BioNTech and Fosun Pharma announced the arrival of approximately 11,500 mRNA-based COVID-19 vaccine doses in China on December 21, 2022, to support vaccination for German expatriates. This shipment includes both the Omicron BA.4/BA.5-adapted bivalent and monovalent vaccines. The vaccines will be available in major cities such as Beijing, Shanghai, and Guangzhou. This delivery marks a significant milestone in their collaboration, aimed at addressing the COVID-19 pandemic.

BioNTech SE (Nasdaq: BNTX) has made significant progress in establishing scalable mRNA vaccine production in Africa. The first BioNTainer's six ISO-sized shipping containers are ready for shipment to Kigali, Rwanda, expected by Q1 2023. Concurrently, the company is constructing a state-of-the-art manufacturing facility in Kigali, which aims to serve as a hub for decentralized vaccine production across Africa. Furthermore, BioNTech is advancing mRNA vaccine candidates targeting malaria and tuberculosis, anticipated to enter human trials by early 2023.

BioNTech SE (Nasdaq: BNTX) has initiated a first-in-human Phase 1 clinical study for BNT163, a herpes simplex virus (HSV) vaccine aimed at preventing genital lesions caused by HSV-2 and potentially HSV-1. This study is part of a collaboration with the University of Pennsylvania, addressing a significant unmet medical need as no vaccine for HSV-related conditions is currently available. The trial will recruit about 100 healthy volunteers aged 18-55 to evaluate the safety, tolerability, and immunogenicity of BNT163, which encodes three HSV-2 glycoproteins.

Pfizer and BioNTech Announce FDA Fast Track Designation

On December 9, 2022, Pfizer Inc. and BioNTech SE received Fast Track Designation from the FDA for their mRNA combination vaccine candidate targeting influenza and COVID-19. This designation aims to expedite the development of vaccines addressing serious health conditions. Their Phase 1 trial will assess the vaccine's safety and immunogenicity in healthy adults. This combined vaccine could simplify immunization strategies against evolving respiratory diseases, which pose significant public health challenges.

Pfizer and BioNTech announce the FDA's Emergency Use Authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a third 3-µg dose in the primary vaccination series for children aged 6 months to 4 years. Given the urgent need due to rising COVID-19 cases and respiratory illnesses in young children, vaccine doses will ship immediately upon CDC recommendation. The EUA is supported by clinical data and aims to enhance protection against severe illness in this age group.

BioNTech (Nasdaq: BNTX) and Pfizer announced the FDA's Emergency Use Authorization for their Omicron BA.4/BA.5-adapted bivalent vaccine as a third 3-µg dose for children aged 6 months to 4 years. This addition allows a three-dose primary series, enhancing protection in a vulnerable age group amid increasing COVID-19 and respiratory illness rates across the U.S. Vaccine shipments will commence upon CDC recommendation. The companies aim to broaden access to variant-adapted vaccines for children as they continue combating COVID-19.