Visgenx extends collaboration with Charles River Laboratories to manufacture gene therapy treatment for AMD

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Visgenx, Inc. has extended their contract development and manufacturing organization (CDMO) collaboration with Charles River Laboratories International, Inc., for VGX-0111. This compound is a gene therapy treatment being developed by Visgenx for dry age-related macular degeneration (AMD).¹

William Pedranti, CEO of Visgenx shared the company’s confidence in the manufacturing process of VGX-0111, saying, "Manufacturing of gene therapies is highly complex and product quality is of paramount importance. We have the utmost confidence in Charles River to manufacture for VGX-0111 as we work toward our goal to bring treatment for those suffering from dry-AMD."¹

According to the company’s press release¹, following Visgenx's Type B pre-IND meeting with the FDA in the summer of 2023, Charles River will begin manufacturing materials for VGX-0111 with the goal of initiating a clinical proof-of-concept in 2025. The material manufactured by Charles River will support a good laboratory practice (GLP) pre-clinical toxicology study and follows a prior adeno-associated virus (AAV) production collaboration.

Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions at Charles River commented on the partnership with Visgenx, saying, "We are excited to expand our partnership with Visgenx on this gene therapy. The collaboration will tap into our premier gene therapy CDMO capabilities, and we are thrilled that our expertise will help to bring VGX-0111 one step closer to the clinic."¹

Reference:

1. Visgenx and Charles River Announce Expansion of Gene Therapy Manufacturing Alliance. Visgenx. December 7, 2023. Accessed December 11, 2023. https://www.prnewswire.com/news-releases/visgenx-and-charles-river-announce-expansion-of-gene-therapy-manufacturing-alliance-302008215.html