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Genprex Provides Clinical and Corporate Update

April 16, 2018

AUSTIN, Texas, April 16, 2018 /PRNewswire/ -- Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing immunogene therapy for non-small cell lung cancer, today announced a clinical and corporate update.  

Genprex Logo (PRNewsfoto/Genprex, Inc.)

Rodney Varner, Chairman and CEO, remarked, "2017 was a pivotal year for Genprex, laying the groundwork for 2018 and beyond. We are dedicated to developing our novel therapeutic candidate, Oncoprex™, as a potential new treatment for non-small cell lung cancer and look forward to advancing Oncoprex in combination with targeted therapy and immunotherapy drugs through clinical trials."

Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated, "We believe that Oncoprex may provide medical benefit in several subpopulations of NSCLC for which there is an unmet medical need and may provide pathways for expedited approval by the FDA."

Clinical Development Highlights

  • Announced in January 2017 positive interim data from the Phase II portion of the ongoing Phase I/II clinical trial evaluating OncoprexTM in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients, with and without EGFR mutations, who have failed at least two drug regimens.  Of the 39 patients allowed in the protocol for the Phase II portion of the trial, 10 have been enrolled and nine are evaluable under the trial protocol as they received two or more cycles of the treatment.
    • Interim results showed that four of the patients had tumor regression and one patient had a Complete Response, or CR, under the RECIST criteria. The patient with the CR had disappearance of the lung primary tumor, as well as lung, liver, and lymph node metastases.
    • For the nine patients evaluated to date, the response rate was 11% and the disease control rate was 78%.
  • The Company's scientific collaborators at a major university research center in Houston, Texas, presented pre-clinical data at American Association of Cancer Research (AACR) Annual Meeting in April 2017, revealing significant anti-tumor effects of TUSC2 in combination with PD-1 checkpoint blockade in lung cancer.
    • TUSC2 and PD-1 blockade demonstrated increased survival in mice and elevated immune system activity, including upregulation of natural killer cells and cytotoxic T-cells.

Corporate Update

  • Priced initial public offering (IPO) in March 2018 and  common stock commenced trading on the NASDAQ Capital Market under the symbol "GNPX." Completed IPO in April 2018 of 1,280,000 shares of the Company's common stock at $5.00 per share, resulting in gross proceeds of $6.4 millionNetwork1 Financial Securities, Inc. acted as the lead underwriter for the offering. 
  • Appointed Julien L. Pham, MD, MPH, in April 2018 as the Company's President and Chief Operating Officer to lead clinical development program for Oncoprex and expand strategic partnerships.
  • Recognized in November 2017 as a finalist in the Fierce Technology Award category of the Fierce Innovation Awards.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities of Genprex, Inc. or of any other issuer.  Genprex has filed a registration statement on Form S-1 with the Securities and Exchange Commission for the initial public offering of its common stock.  The registration statement, as amended by a post-effective amendment, has been declared effective by the SEC.  To review a filed copy of the prospectus that constitutes a part of the post-effective amendment, click on the following link:

http://ir.genprex.com/static-files/75c94d64-7de7-497b-b939-5ea8684c8e45

You may also get this document for free by visiting EDGAR on the SEC Web site at www.sec.gov.  Alternatively, a copy of the prospectus may be obtained from the offices of Network 1 Financial Securities, Inc., The Galleria, Penthouse, 2 Bridge Avenue, Building 2, Red Bank, NJ 07701, or by calling toll-free 1-800-886-7007, or by email at info@netw1.com.

Forward Looking Statements
Statements contained in this press release that are not statements of historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements are subject to risks and uncertainties, the actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about Genprex's business plans, statements about the timing and success of the Company's existing and planned clinical trials, statements about the development of the Company's current and potential future product candidates and statements about the Company's plans to seek regulatory approval of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of the Company's product candidate development activities and current and planned clinical trials; the Company's ability to execute on its strategy; regulatory developments in the United States and foreign countries; and the Company's estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Genprex's 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. Genprex does not undertake any obligation to update these statements to reflect any events that occur or facts that exist after the date on which the statements were made.

About Genprex, Inc.

Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel 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.

Contact:              

Investors:
Stephanie Carrington
ICR Healthcare
646-277-1282
Stephanie.Carrington@icrinc.com

Media:
James Heins
ICR Healthcare
203-682-8251
James.Heins@icrinc.com

 

 

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SOURCE Genprex, Inc.