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Genprex says partner successfully completes manufacturing of TUSC2 plasmid DNA for Oncoprex gene therapy treatment

Historically, the manufacturing steps of combining the plasmid DNA with the lipid nanovesicles of Oncoprex has been done for Genprex at the MD Anderson Cancer Center

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Since Genprex’s IPO in June 2018, the company has been working to transfer and scale up these processes through other contract manufacturers

Genprex, Inc. (NASDAQ:GNPX) said Tuesday that its partner, Aldevron has successfully completed manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for the company’s initial product candidate, Oncoprex, an immunogene therapy to treat non-small cell lung cancer.

The Austin, Texas-based clinical-stage gene therapy company noted that Oncoprex consists of a TUSC2 plasmid DNA gene encapsulated in a nanovesicle made from lipid molecules with a positive electrical charge.

READ: Genprex Inc initiates first phase of branding for its lead drug candidate, Oncoprex immunogene therapy

Historically, the manufacturing steps of combining the plasmid DNA with the lipid nanovesicles of Oncoprex has been done for Genprex at the MD Anderson Cancer Center, which has been undertaking research studies on the gene therapy.

Since Genprex’s IPO in June 2018, the company has been working to transfer and scale up these processes through other contract manufacturers.

The company pointed out that that the US 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% of its focus during reviews of gene therapy candidates to manufacturing and quality concerns.

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, the company said.

Manufacturing top priority since IPO

Genprex has made manufacturing one of its top priorities since its IPO and during that time it has been building out its manufacturing process development to support this expansion and advance its commercial scaling capabilities.

Earlier this year, the company 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.

Last week, Genprex initiated the first phase of branding for Oncoprex and said it has completed the creation and submission of non-proprietary drug name selections to the American Medical Association’s United States Adopted Names (USAN) Council.

The clinical-stage gene therapy company said, upon receiving feedback from the USAN Council - which is expected later this year – it will submit its non-proprietary drug name selections to the World Health Organization for International Nonproprietary Names (INN) status.

The company expects to obtain an approved non-proprietary drug name by mid-year 2020.

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NASDAQ:GNPX
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