Genprex, Inc. (NASDAQ:GNPX), a clinical-stage gene therapy company, today announced anticipated milestones and future guidance on the clinical development programs, manufacturing and strategy for bringing its lead drug candidate, Oncoprex immunogene therapy, to market.
Rodney Varner, Genprex’s chairman and chief executive officer commented: “These milestones emphasize our commitment to developing potentially life-changing gene technologies for cancer patients who need them most.”
“We continue to dedicate our efforts toward developing Oncoprex for non-small cell lung cancer (NSCLC) and we believe that achievement of these milestones will enable us to advance our gene therapy platform and position us to bring our drug candidate to commercialization,” he added.
In the second half of 2019, Genprex said it plans to establish scalability parameters of new, optimized manufacturing method for lipid nanoparticle delivery system as part of its new research and development program.
It also intends to complete protocol for the Oncoprex + immunotherapy clinical trial; prepare and file an IND (Investigational New Drug) program for the Oncoprex + immunotherapy clinical trial; and determine clinical site selection, expansion strategy and contract with clinical sites for Oncoprex + erlotinib clinical trials.
In the first half of 2020, the company aims to complete the manufacturing scale-up to support trial site expansion and commercial-scale development; and complete the preparation of lipid nanoparticle delivery system and TUSC2 DNA plasmid for clinical expansion.
It also anticipates signing a contract with new clinical trial sites for a Oncoprex + immunotherapy clinical trial, and to begin enrolling patients at those new clinical sites.
In addition to the milestone updates, Genprex also unveiled an updated corporate presentation on its company website, with an overview of the limitations to current NSCLC treatment and a swimmer plot demonstrating results to date of its Phase I/II clinical trial administering Oncoprex in combination with erlotinib against NSCLC.
The company also recently launched a new interactive timeline on its website where visitors can follow the company’s success since its inception.
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