Touchlight Announces First FDA Clearance of an IND Utilising Doggybone DNA
- Enzymatic doggybone DNA material used in GMP production of a cell therapy by a US-based client.
- Major landmark demonstrates the clinical adoption of Touchlight's proprietary technology across modalities.
HAMPTON, England--(BUSINESS WIRE)-- Touchlight Genetics Ltd, 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.
Karen Fallen, CEO, Touchlight commented: “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.”
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.
Notes to Editors
Touchlight is a privately-owned CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA™) to enable the development of genetic medicines. Touchlight provide rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through development and supply, to licencing and tech transfer for use in-house.
Find out more at www.touchlight.com