Touchlight’s enzymatic doggybone DNA used in the manufacture of Versameb’s VMB-100 for first-in-human clinical study
Touchlight, a CDMO enabling the development of genetic medicines with its enzymatic doggybone DNA (dbDNA) technology, today announced that the Company has used its proprietary dbDNA as a critical starting material for manufacturing of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1) to support Versameb’s first-in-human clinical study to treat chronic stress urinary incontinence (SUI).
Following the recent U.S. Food and Drug Administration (FDA)’s clearance of its Investigational New Drug (IND) application, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study of VMB-100 in the first half of 2024.
This FDA clearance represents a further milestone for Touchlight’s enzymatic dbDNA and follows the prior announcement from February 2023 of the first client adopting dbDNA for clinical development in the US. This IND marks the third product to enter clinical development using the dbDNA platform, further demonstrating its regulatory adoption in both the US and Europe. Touchlight’s enzymatic DNA platform is the first such platform to have a Drug Master File (DMF) accepted by the FDA, enabling a simple option for clients adopting the dbDNA platform.
Karen Fallen, CEO, Touchlight commented: “We would like to congratulate Versameb on this achievement and wish them success with their upcoming first-in-human study. We are proud to support them as they progress into clinical development. Continued clinical advancement of our dbDNA technology is a major achievement for Touchlight and is testament to all the hard work and dedication of our team.”
Klaas Zuideveld, CEO of Versameb, said: “Touchlight’s dbDNA vector technology has proven instrumental in supporting the development of our novel RNA-based therapeutics, including VMB-100. We are pleased with the ongoing progress achieved through our manufacturing agreement with Touchlight, and we believe the Company’s dbDNA technology will continue to enhance efficiency in manufacturing and supplying VMB-100, as well other pipeline products. We are excited to launch our Phase 2a study to further evaluate the safety, tolerability, and efficacy of VMB-100 and move closer to bringing the first FDA-approved SUI therapeutic to market.”
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 of interest of more than 20kb and accommodate sequences typically unstable as plasmid DNA in E. coli, such as those found in viral vector and mRNA production.
