Touchlight Genetics Ltd., a Contract Development and Management Organization (CDMO) pioneering enzymatic DNA production to enable genetic medicines, announced the first FDA clearance of an Investigational New Drug (IND) application using doggybone DNA (dbDNA).

Within the trial, 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.

According to Touchlight, the trial sponsor has operational facilities across the US.

The announcement follows the recent FDA acceptance of the Drug Master File (DMF) for GMP grade dbDNA.

The company said that this recent landmark represented a significant step towards regulatory adoption with dbDNA, which is recognized as the first enzymatic DNA platform with a DMF.

Karen Fallen, CEO, Touchlight said: “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.”

Fallen added: “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 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.

In addtion, 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.