AUSTIN, Texas & CAMBRIDGE, Mass.--(BUSINESS WIRE)--

(NASDAQ: ), a clinical-stage gene therapy company, today announced anticipated milestones and future guidance on its clinical development programs, manufacturing and strategy for bringing its lead drug candidate, Oncoprex™ immunogene therapy, to market.

These anticipated milestones and future guidance are incorporated into the latest update of the company’s corporate presentation, which can be found on the .

“These milestones emphasize our commitment to developing potentially life-changing gene technologies for cancer patients who need them most,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “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.”

Anticipated milestones and future guidance:

2H 2019

• Establish scalability parameters of new, optimized manufacturing method for lipid nanoparticle delivery system as part of new Genprex research and development program
• Complete protocol for Oncoprex + immunotherapy clinical trial
• Prepare and file IND for Oncoprex + immunotherapy clinical trial
• Determine clinical site selection, expansion strategy and contract with clinical sites for Oncoprex + erlotinib clinical trial

1H 2020

• Complete manufacturing scale-up to support trial site expansion and commercial-scale development
• Complete preparation of lipid nanoparticle delivery system and TUSC2 DNA plasmid for clinical expansion
• Contract with new clinical trial sites for Oncoprex + immunotherapy clinical trial
• Begin enrolling patients at new clinical sites for Oncoprex + immunotherapy clinical trial

In addition to the milestone updates, Genprex also unveiled in its updated , 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. Genprex also recently launched a new on its website where visitors can follow the company’s success since its inception.

About Genprex, Inc.

Genprex, Inc. is a clinical stage gene therapy company developing potentially life-changing technologies for cancer patients, based upon a unique proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. For more information, please visit the company’s web site at or follow Genprex on , and .

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 our stated milestones and our ability to advance the clinical development, manufacturing and commercialization of our product candidates, and the effects of Oncoprex on cancer. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include our ability to achieve our stated milestones, the timing and effect of our achieving those milestones, and of other factors, on the clinical development, manufacturing and commercialization of our product candidates, the presence and level of TUSC2’s effect on cancer, 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.

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