The biotech has agreed a Letter of Intent with the State of Victoria in Australia 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 also plans to create a clinical scale end-to-end mRNA manufacturing facility based on its ‘BioNTainer’ solution – a modular manufacturing concept for mRNA manufacturing and formulation - in Melbourne with the aim of supporting the design, manufacture and clinical testing of product candidates.
And BioNTech will also establish its AI-driven early warning and identification tech at the site, which will be used to detect future disease threats and develop new treatments and vaccines in response.
‘Major coup for Victoria’
Victoria is already the leader in Australian pharmaceutical and biological manufacturing, responsible for nearly 60% of Australia’s pharmaceutical exports (making it the highest value advanced manufactured export).
The state now wants to lead the way in mRNA manufacturing in the country, having already attracted Moderna to build an mRNA manufacturing facility in Melbourne (set to be operational in 2024 with capacity of up to 100 million vaccine doses annually).
Given the strength of BioNTech’s global network, the German biotech's new facility is also expected to attract interest from researchers locally, regionally and globally. Victoria Treasurer Tim Pallas describes the partnership with BioNTech as a ‘major coup for Victoria’, with the plans providing ‘incredible collaboration opportunities for our researchers and international biotech companies’.
BioNTech CEO and co-founder Prof. Ugur Sahin, M.D. adds that the facility will focus on collaborations in the Asia-Pacific region.
“Science and innovation can only make a difference if it is applied outside of the laboratories and reaches people worldwide," he said.
“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.”
R&D center and manufacturing capabilities
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.
BioNTech will also create end-to-end clinical-scale manufacturing facility for mRNA-based medicines and product candidates in Melbourne with its BioNTainer, a mobile modular manufacturing unit requiring limited space for operation. This will allow for timely and flexible local production of different mRNA-based constructs and products across a variety of indications, and is expected to create hundreds of jobs during construction and operation in Melbourne.
CAR-T cell therapies
BioNTech also pledges to further strengthen the clinical development capabilities in Australia: particularly with regards to its oncology pipeline (which currently has a total of 18 candidates in 23 ongoing clinical trials).
The company is currently recruiting cancer patients for two Phase 2 mRNA-based product candidates in Australia, BNT111 and BNT113. It is now planning to further expand its clinical development, including for its candidate BNT211, which combines a CAR-T cell therapy approach with an mRNA vaccine (the combination of BioNTech's CAR-T and FixVac platform technologies creates a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech’s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen.)