Genomic Analyses Suggest No Risk of Vancomycin Resistance Transfer by Strain VE202-06

ABSTRACT In 2016, the US Food and Drug Administration published guidance for the early development of live biotherapeutic products (LBPs)1. Of particular importance is the characterization of LBP strains and the potential transfer of antimicrobial resistance (AMR) genes to relevant microbial organisms in the recipient’s microbiota. Van der Lelie et al2, make unsupported claims that the LBP strain VE202-06 encodes a transferable vancomycin resistance element. Here we provide our analysis of the potential transfer of AMR by strain VE202-06. These data indicate that strain VE202-06 has no risk of transferring AMR to relevant microbial organisms. Competing Interest Statement The authors declare the following competing interests: A.R.W, W.C, and J.M.N are employees of Vedanta Biosciences and have an equity interest in the company. Vedanta Biosciences holds patents related to this work. W.V.S is a paid consultant for Vedanta Biosciences. The authors vouch for the accuracy and completeness of the data and data analyses.