On December 16, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or the "Company") reported plans to accelerate and broaden the clinical development of its cancer immunotherapy pipeline in the Asia-Pacific region by expanding its clinical footprint to East Asia (Press release, BioNTech, DEC 16, 2022, View Source [SID1234625350]). The first regional clinical trial sites for the Company’s mRNA-based cancer immunotherapies are planned to be activated in Taiwan to initially evaluate BioNTech’s cancer product candidate BNT113 against head and neck cancer. BNT113 is expected to be the first product candidate from a potential wave of novel cancer immunotherapies that BioNTech anticipates to evaluate in the region. These plans are part of BioNTech’s Asia-Pacific strategy, which has the aim of developing, manufacturing and broadening the access to innovative medicines in Asia, with a focus on treatments addressing the most common types of cancer. As part of these plans, BioNTech has been collaborating with the YongLin Healthcare Foundation and in November 2022, BioNTech signed a Memorandum of Understanding (MoU) with Retain Biotech Corp. ("Retain"), a Taiwan-based organization that is sponsored by the YongLin Healthcare Foundation and engaged in precision medicine, genomic medicine and cell therapy in oncology.
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"Taiwan is one of the renowned biomedical hubs in the Asia-Pacific region given its state-of-the-art health care system, medical research capacity and collaborative approach to work with leading companies and institutions around the world. Our Asia-Pacific strategy is based on powerful partnerships and a joint vision," said Sean Marett, Chief Business and Chief Commercial Officer of BioNTech. "We are looking forward to working with Retain in our efforts to facilitate the clinical development of novel immunotherapies in oncology. Our aim is to accelerate the development of innovative therapies to help address cancers that are highly prevalent in the region."
As part of the MoU, Retain is expected to initially support clinical evaluation of BioNTech’s mRNA-based product candidate BNT113 for the treatment of head and neck cancer in a randomized Phase 2 clinical trial across the region. Head and neck cancer is the seventh most common cancer globally, with one of the highest incidences being observed in the Asia-Pacific region.1 BNT113 is based on BioNTech’s proprietary mRNA platform FixVac. The Company plans to evaluate the candidate in the broader Asia-Pacific region with first clinical trial sites in Australia’s state of Victoria as well as in Taiwan. In addition, BioNTech and Retain plan to assess the potential to expand clinical activities to Japan, South Korea, Singapore and other East Asian countries and regions for a number of additional product candidates from BioNTech’s oncology pipeline which currently encompasses a total of 18 product candidates in 23 ongoing clinical trials.
As part of BioNTech’s Asia-Pacific strategy, the Company is in parallel establishing clinical and commercial-scale manufacturing in the region. In November 2022, BioNTech announced its acquisition of a GMP-certified manufacturing facility in Singapore in support of the R&D and potential launch activities for product candidates across the Asia-Pacific region and with the potential to expand the production beyond mRNA, such as cell therapies. In addition, BioNTech announced plans to set-up a clinical scale end-to-end mRNA manufacturing facility based on its BioNTainer solution in Melbourne aiming to enable access to mRNA technology and promote research collaborations in the Asia-Pacific region.
BioNTech has already established subsidiaries in Singapore, Shanghai, and Melbourne, as well as registered a representative office in Taipei, which BioNTech aims to serve as regional innovation hubs as part of the Company’s global network. BioNTech expects to create hundreds of jobs across these regional sites by 2024 across multiple functions.