Genprex Inc (NASDAQ: GNPX) made a huge announcement today surrounding its lead drug candidate, Oncoprex. The company’s manufacturing partner has taken a significant step in the right direction. Here’s what’s going on:
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GNPX Stock Could See Gains On Manufacturing News
In a press release issued early this morning, Genprex said that its manufacturing partner, Aldevron, has hit a key milestone. The partner has successfully completed the manufacturing of the TUSC2 plasmid DNA. This was a milestone outlined on the manufacturing agreement between the companies that was announced in September of last year.
Oncoprex is a gene therapy candidate being developed as a potential treatment for various forms of cancer. The treatment contains a TUSC2 plasmid DNA that is manufactured by Aldevron.
This TUSC2 plasmid DNA is then encapsulated in a nanovesicle that’s made from lipid molecules with a positive electrical charge. In a statement, Julien Pham, MD, President and COO at GNPX, had the following to offer:
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.
This News Is Significant
This is huge news for GNPX and its investors. After all, the FDA has made manufacturing a top priority for cell and gene therapy companies. In fact, in 2018, Scott Gottlieb, former commissioner of the Administration said that the agency devotes about 80% of its focus during reviews of gene therapy candidates to manufacturing and quality concerns.
As the FDA continues to receive a flood of new drug applications for gene therapy and cell therapy candidates, the FDA is pushing companies not only to demonstrate efficacy and safety, but to also be able to manufacture these drugs on a large scale.
Considering this, manufacturing has been a top priority for Genprex, with today’s news being a big win on the development path. All in all, as GNPX continues to work to develop Oncoprex in the clinic, it is also highly prioritizing the manufacturing side of development, making this stock one that’s well worth watching.
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CNA Finance, parent company to Alpha Stock News, has been paid to cover Genprex news.