BioNTech to create clinical trial hub in Taiwan for mRNA-based cancer immunotherapies

By Rachel Arthur

- Last updated on GMT


Related tags mRNA BioNTech Asia

BioNTech will create its first regional clinical trial sites in East Asia: with the launch of activities in Taiwan for an mRNA head and neck cancer candidate.

The German biotech has been collaborating with the YongLin Healthcare Foundation and recently signed a Memorandum of Understanding (MoU) with Retain Biotech Corp. (a Taiwan-based organization sponsored by the YongLin Healthcare Foundation and engaged in precision medicine, genomic medicine and cell therapy in oncology).

As part of the MoU, Retain will 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 - which is the seventh most common cancer globally - has one of the highest incidences in the Asia-Pacific region. 

BNT113 is based on BioNTech’s proprietary mRNA platform FixVac. BNT113 is expected to be the first product candidate from a 'potential wave' of novel cancer immunotherapies that BioNTech expects to evaluate in the region.

These plans are part of BioNTech’s Asia-Pacific strategy: which aims to develop, manufacture and expand access to medicines in Asia with a particular focus on the most common types of cancer. 

Clinical trials in Australia

BNT113 will also be evaluated across the broader region with first clinical trial sites in Australia’s state of Victoria as well as in Taiwan. In addition, BioNTech and Retain are looking at expanding 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 the Asia-Pacific strategy, the company is in parallel establishing clinical and commercial-scale manufacturing in the region. Last month it acquired a GMP-certified manufacturing facility in Singapore​ from Novartis to support 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​.

BioNTech has already established subsidiaries in Singapore, Shanghai, and Melbourne, as well as registered a representative office in Taipei: which will become regional innovation hubs in the company's global network. It expects to create 'hundreds of jobs' across these regional sites by 2024 across multiple functions.

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