Genprex Partner Aldevron Completes Step in Mfg. for Oncoprex Clinical Devt. Program

Clinical-stage gene therapy company Genprex, said that that 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," said Julien Pham, president and chief operating officer. "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."
 
Genprex has made manufacturing one of its top priorities since its IPO in 2018. During that time, Genprex has been building out its manufacturing process development to support this expansion and advance its commercial scaling capabilities.
 
Earlier this year, Genprex strengthened its senior team with the appointment of Eric Chapdelaine as senior director of pharmaceutical sciences and manufacturing to support the company’s manufacturing, technical operations, and supply chain management.

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