• BioNTech and Australia’s State of Victoria will establish an mRNA research and innovation center to strengthen translational research for innovative medicines from discovery to delivery
• As part of the partnership, BioNTech is committed to building a BioNTainer^® facility for end-to-end clinical scale manufacturing of mRNA-based products and candidates in Melbourne
• BioNTech plans to further expand its clinical development capabilities in Australia and evaluate the testing of additional clinical cancer product candidates, including the autologous CAR-T cell therapy candidate BNT211, in addition to two Phase 2 candidates currently being tested in Australia 

BioNTech SE (Nasdaq: BNTX) today announced that it has agreed a Letter of Intent with the State of Victoria in Australia on a strategic partnership between the State and BioNTech to collaborate on the research and development of potential mRNA-based vaccines and therapies. As part of the partnership, the parties will establish a research and innovation center in Melbourne to facilitate the transition of encouraging academic research into clinical development. BioNTech plans to set up a clinical scale end-to-end mRNA manufacturing facility based on its BioNTainer solution in Melbourne with the aim of supporting the design, manufacture and clinical testing of product candidates. Part of BioNTech’s global network, the facility is expected to attract interest from researchers locally, regionally and globally.

“Science and innovation can only make a difference if it is applied outside of the laboratories and reaches people worldwide. This partnership is a major step forward to enable access to mRNA technology and promote collaborations in the Asia-Pacific region,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Australia provides excellent academic research, and we are looking forward to collaborating with world-class scientists and researchers to strengthen Australia’s mRNA ecosystem and to jointly develop potential novel treatments and vaccines for people worldwide.”

As part of this collaboration, the State of Victoria and BioNTech will establish a research and innovation center, directed in partnership with the State, with the aim to support Australia’s mRNA ecosystem by curating projects and to determine their potential transition into preclinical and clinical development, supported by BioNTech’s advice and know-how. The partnership will also include the research and development of experimental therapies including mRNA-based product candidates for indications with high unmet medical need, for instance in oncology. BioNTech will support the R&D efforts on a project-by-project basis with the Company’s expertise in mRNA research and clinical development of potential new products.

In addition to driving innovative translational research, BioNTech will also support local delivery by developing and commissioning an end-to-end clinical-scale manufacturing facility for mRNA-based medicines and product candidates in Melbourne, Victoria. BioNTech has developed the BioNTainer, a mobile modular manufacturing unit requiring limited space for operation, allowing for timely and flexible local production of different mRNA-based constructs and products across a variety of indications, and expects to create hundreds of jobs during construction and operation in Melbourne.

“We at BioNTech are committed to global public health, and as we continue to expand internationally, we look forward to working jointly to drive the development of innovative medicines,” said Dr. Sierk Poetting, COO of BioNTech. “Our BioNTainers are designed as turnkey manufacturing sites for mRNA-based medicines and product candidates. In Melbourne, our BioNTainers will allow for an end-to-end production including fill and finish for clinical-scale manufacturing of mRNA candidates, once approved.”

BioNTech intends to further strengthen the clinical development capabilities in Australia and includes sites that aim to accelerate the development of its clinical stage oncology pipeline which currently encompasses a total of 18 product candidates in 23 ongoing clinical trials. BioNTech is currently recruiting cancer patients for two Phase 2 mRNA-based product candidates in Australia – BNT111 and BNT113 – and plans to further expand its clinical development, including for the Company’s candidate BNT211, which combines a CAR-T cell therapy approach with an mRNA vaccine.

About BioNTech

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, bispecific immune checkpoint 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. For more information, please visit www.BioNTech.com.

BioNTech Forward-looking Statements

This statement 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: BioNTech’s potential collaboration between the State of Victoria in Australia and its leading scientific institutions with regards to pandemic preparedness and the development of innovative medicines; the ability of BioNTech to reach an agreement with potential collaboration partners in Australia; the ability of BioNTech to produce, deliver and install mRNA container manufacturing facilities in Australia, including the ability to meet all necessary infrastructure, technology and regulatory requirements; potential delays in the establishment of the BioNTainers in Australia, due to unforeseen events, including, but not limited to, global supply chain issues; the development of quality assurance capabilities to remotely support manufacturing sites in Australia; the scale-up of local know-how and training in Australia; the development of sustainable RNA vaccine capacities, production and supply solutions in Australia and the nature, timing, and feasibility of these solutions; the potential safety and efficacy of the product candidates; BioNTech’s ability to develop and commercialize products; and BioNTech’s anticipated market opportunity and size for its product candidates, the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved. Any forward-looking statements in this statement are based on BioNTech’s 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.

For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 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.

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