Update on First BioNTainer for African-based mRNA Manufacturing Facility
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 been flown to Kigali, Rwanda, where they have been welcomed by Sabin Nsanzimana, M.D., Ph.D., the Minister of Health of Rwanda and Sierk Poetting, Ph.D., Chief Operating Officer at BioNTech. Media material from today’s arrival of the containers and their unloading at Kigali International Airport is available here.
In parallel, BioNTech continues to build and develop its state-of-the-art manufacturing facility for the production of mRNA-based drugs and product candidates in Kigali, Rwanda, following the groundbreaking in June 2022. The facility will initially house two sets of BioNTainers for mRNA vaccine production in bulk and is expected to become the first node in a decentralized and robust end-to-end manufacturing network in Africa. BioNTech is also pursuing facility developments in Senegal and South Africa, in close coordination with each country. Vaccines deriving from this envisioned pan-African infrastructure will be intended for people residing in member states of the African Union, with the aim to support access to novel medicines.
BioNTech is advancing mRNA-based vaccine candidates to address malaria and tuberculosis based on the Company’s mRNA platform. The malaria vaccine candidate BNT165 entered clinical trials in December 2022. The clinical trials for the tuberculosis vaccine candidate BNT164 are expected to enter first-in-human trials shortly.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, direct or indirect statements concerning: the ability of BioNTech to produce, deliver and install mRNA container manufacturing facilities for the African continent, including the ability to meet all necessary infrastructure, technology and regulatory requirements; the ability of BioNTech to reach an agreement with potential collaboration partners in Africa to establish an end-to-end manufacturing network in Africa; the development of quality assurance capabilities to remotely support manufacturing sites in Africa; the scale-up of local know-how and training in Africa; BioNTech’s malaria, tuberculosis and other infectious disease vaccine development programs; timing for selecting clinical candidates for these programs and the commencement of clinical trials, as well as any data readouts; the development of sustainable mRNA vaccine capacities, production and supply solutions on the African continent and the nature, timing, and feasibility of these solutions; and the potential safety and efficacy of the product candidates. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies regarding timing and requirements for additional clinical trials; potential delays in the establishment of the BioNTainers and BioNTech operations in Africa, due to unforeseen issues, including, but not limited to, global supply chain issues; BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply agreements and the timing of delivery of doses thereunder, efforts to help ensure global equitable access to the vaccine, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); BioNTech’s anticipated market opportunity and size for its product candidates and the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved; and BioNTech’s ability to produce comparable clinical results in future clinical trials.
For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
Jasmina Alatovic photo BioNTech