Visgenx and Charles River Announce Expansion of Gene Therapy Manufacturing Alliance

Charles River will manufacture for Visgenx's investigational gene therapy treatment for dry Age-Related Macular Degeneration

SAN DIEGO, Dec. 7, 2023 /PRNewswire/ -- Visgenx, Inc., a biotechnology company focused on developing gene therapies for degenerative retinal diseases, announced an extension of their contract development and manufacturing organization (CDMO) collaboration with Charles River Laboratories International, Inc., for VGX-0111, a gene therapy being developed by Visgenx for dry age-related macular degeneration (AMD).

"Manufacturing of gene therapies is highly complex and product quality is of paramount importance," said William Pedranti, CEO, Visgenx. "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."

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. 

"We are excited to expand our partnership with Visgenx on this gene therapy," said Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River. "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."

What is Dry-AMD?
Dry-AMD is a progressive eye disease that affects over 11 million people in the United States and is the leading cause of severe vision loss or blindness in adults over age 50. There is no known cure for dry-AMD and only limited treatments are available.

Dysregulation of very long-chain fatty acid biosynthesis resulting from declining expression of a gene known as ELOVL2 is believed to be a contributor to dry-AMD. Numerous studies have elucidated the importance of ELOVL2 in maintaining the function and promoting survival of retinal cells and other tissues. The downregulation of ELOVL2 may lead to accelerated cellular aging and potentially form the foundational basis of dry-AMD.

Visgenx's lead product, VGX-0111, a candidate gene therapy based on the ELOVL2 gene, is intended to restore a physiologically healthy level of ELOVL2 expression, thereby potentially slowing or halting vision loss resulting from dry-AMD.

About Visgenx
Visgenx, Inc. is a biotechnology company focused on developing gene-based therapeutics for degenerative retinal diseases. Visgenx's initial product is VGX-0111, an ELOVL2 gene therapy candidate being developed for the treatment of dry Age-related Macular Degeneration (AMD). Close to 200 million people suffer from dry AMD globally; it is a leading cause of blindness. For more information on Visgenx, visit www.visgenx.com.

Forward Looking Statements
This press release contains forward-looking statements related to Visgenx, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the potential for VGX-0111 as a treatment for dry-AMD. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements include that the therapy may not be effective at treating dry-AMD. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

@ 2023 Visgenx, Inc. All Rights Reserved. 

CONTACT: William Pedranti, william@visgenx.com

SOURCE Visgenx