Touchlight announces first FDA clearance of an IND utilising doggybone DNA
Published: 28 February 2023
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Enzymatic doggybone DNA material used in GMP production of a cell therapy by a US-based client.
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Major landmark demonstrates the clinical adoption of Touchlight’s proprietary technology across modalities.
Hampton, UK, 28 February 2023 – Touchlight, a CDMO pioneering enzymatic DNA production to enable genetic medicines, today announced the first FDA clearance of an Investigational New Drug (IND) application in the US utilising doggybone DNA (dbDNA™).
Within the trial now planned by one of Touchlight’s clients, dbDNA will be used as an in vitro transcription template for mRNA production in the manufacturing of a cell therapy product. The trial sponsor has operational facilities across the US.
This is a further milestone for enzymatic DNA and follows the recent FDA acceptance of the Drug Master File (DMF) for GMP grade dbDNA. This recent landmark represented a significant step towards regulatory adoption with dbDNA, which is recognised as the first enzymatic DNA platform with a DMF.
“Clinical adoption of dbDNA is a major achievement for Touchlight and is testament to all the hard work and dedication of the team. This next step demonstrates the clinical adoption of Touchlight’s proprietary technology across modalities, with a dbDNA-derived AAV product having previously entered clinical testing in Europe in 2022. We wish our client every success with their upcoming first-in-human study and look forward to further clinical adoption of the dbDNA technology throughout 2023.”
Karen Fallen, CEO, Touchlight
Touchlight’s patented dbDNA technology produces a minimal, linear, double stranded, covalently closed DNA vector through an enzymatic manufacturing process. dbDNA is uniquely positioned for the rapid, synthetic, and scalable manufacture of GMP DNA using a small, simple footprint. The technology can manufacture genes >20kb and accommodate sequences typically unstable as plasmid DNA in E. coli, such as those found in viral vector and mRNA production.
About Touchlight
Touchlight is an innovation-driven leading CDMO pioneering enzymatic GMP DNA production to enable the genetic medicine revolution. As pioneers, with an FDA Drug Master File accepted in 2022 followed in 2025 with the world’s first cell-free DNA GMP license, Touchlight’s enzymatic DNA technology is on the cutting edge of AAV, mRNA, DNA vaccine, and gene editing technology with its state-of-the-art facility recognised by ISPE’s Facility of the Year Awards (FOYA) for Innovation.
With multiple client products already in the clinic, Touchlight’s evidence-based, synthetic DNA manufacturing solutions offer a scalable, sustainable alternative to plasmid DNA (pDNA) for all stages of pre-clinical, clinical and commercial development. The company and technology are built on the conviction that DNA is fundamental to the future of medicine. Traditional methods, based on bacterial fermentation, are slow, costly, and unable to meet the growing demands of genetic medicine due to limited scalability and speed. Founded in 2007, Touchlight’s team is inspired by breakthroughs in genetic medicine, recognising the urgent need for innovative DNA production techniques to support the future of genetic therapies.
For more information please contact:
Karen Fallen, Chief Executive Officer
Verna McErlane, Chief Commercial Officer
E: info@touchlight.com
T: +44 20 8481 9200
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