Genprex Manufacturing Partner Aldevron Completes Significant Step in Manufacturing for Oncoprex™ Clinical Development Program
Newly manufactured plasmids will be used in clinical trials evaluating Oncoprex™ in combination with targeted therapies and immunotherapies
AUSTIN, Texas & CAMBRIDGE, Mass.— (August 6, 2019) — Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, announced 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. 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 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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of TUSC2 on cancer, the effect of products and services provided by Aldevron and our other commercial partners on the development of Oncoprex™, the build-out, transfer and scale-up of our manufacturing processes, our current and planned clinical trials, and the commercialization of our product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of TUSC2’s effect on cancer, our ability to utilize the products and services of Aldevron and our other commercial partners, the ability of those products and services to influence the development of Oncoprex™, our ability to successfully build-out and scale-up our manufacturing process, our ability to successfully transfer manufacturing processes to commercial maufacturers, as well as the timing and success of our clinical trials and planned clinical trials of TUSC2 and Oncoprex™ and our other potential product candidates and the timing and success of obtaining FDA approval of Oncoprex™ and our other potential product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.