Genprex announced its manufacturing partner, Aldevron, has successfully completed the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA pursuant to the manufacturing agreement between Genprex and Aldevron that was announced in September 2018.
Genprex’s initial product candidate, Oncoprex™ consists of a TUSC2 plasmid DNA manufactured by Aldevron encapsulated in a nanovesicle made from lipid molecules with a positive electrical charge. Historically, the manufacturing steps of combining the plasmid DNA with the lipid nanovesicles of Oncoprex, has been done for Genprex at MD Anderson Cancer Center. Since Genprex’s IPO, the company has been working to transfer and scale up these processes through other contract manufacturers.
“Each successful release of plasmid DNA batches is an important milestone for Genprex as it allows us to not only demonstrate continued progress in coordinating scale-up manufacturing of Oncoprex, but it takes us one step closer to re-entering the clinic with both our EGFR program and our immunotherapy combination programs. Biologics manufacturing, especially for lipid nanoparticle (or LNP) delivered gene therapy, is a complex process, but one we tackle with pride alongside dedicated partners such as Aldevron, through a similar vision to deliver innovative therapies to patients with significant unmet medical needs,” said Julien Pham, MD, Genprex’s President and Chief Operating Officer.
The U.S. Food and Drug Administration (FDA) has made manufacturing a top priority for cell and gene therapy companies. The FDA’s former Commissioner, Scott Gottlieb, noted in 2018 that the agency devotes approximately 80 percent of its focus during reviews of gene therapy candidates to manufacturing and quality concerns. FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, M.D., noted in July 2019 that the agency is adapting to the flood of new drug applications stemming from advances in gene therapy and is shifting its stance toward drug development more than in recent years. This shift emphasizes the need for gene therapy companies to not only demonstrate clinical efficacy but also be able to manufacture these drugs on a large scale.
Genprex has been building out its manufacturing process development to support this expansion and advance its commercial scaling capabilities.