Genprex CEO Commends FDA's Initiative to Accelerate Approval Process for Gene Therapies

Genprex (GNPX), a clinical-stage gene therapy company, announced its support for the FDA's initiative aimed at expediting gene therapy development for rare diseases.

Rhea-AI Summary

Genprex (GNPX), a clinical-stage gene therapy company, announced its support for the FDA's initiative aimed at expediting gene therapy development for rare diseases. The FDA's new approach will allow biomarkers to substitute for traditional biological indicators in clinical trials, potentially accelerating approval processes. Rodney Varner, CEO, emphasized that this initiative is beneficial for advancing Genprex's pipeline of gene therapies, particularly for patients with limited treatment options in cancer and diabetes. The company is utilizing its proprietary ONCOPREX Nanoparticle Delivery System for its oncology program, currently in clinical trials.

Positive

• FDA's initiative may accelerate approval for Genprex's gene therapies.
• Advancement of gene therapy pipeline for cancer and diabetes patients.
• Potential for long-lasting and curative treatments emphasized by the CEO.

Negative

• None.

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Genprex is advancing its novel gene therapies for large patient populations with cancer and diabetes who currently have limited treatment options

AUSTIN, Texas, March 23, 2023 /PRNewswire/ -- Rodney Varner, CEO of Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today commended The U.S. Food and Drug Administration's (FDA) initiative that aims to expedite the development of gene therapies for patients with rare diseases. As such, the FDA announced that it will support using biomarkers as substitutes for other biological indicators in gene therapy clinical trials, accelerating the approval process for companies.

"The FDA's efforts to streamline the regulatory process will help bring much needed therapies to patients more efficiently," commented Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. "This is a positive development for Genprex as we continue to advance our pipeline of gene therapies for patients with limited treatment options. This decision by the FDA also underscores the potential role of gene therapy to provide long-lasting and even curative treatments for diseases that are currently difficult to manage or are untreatable."

About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its proprietary, non-viral ONCOPREX^® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company's lead product candidate, REQORSA^® (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Both NSCLC clinical programs received a Fast Track Designation from the Food and Drug Administration. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

For more information, please visit the Company's web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning 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. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking 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 timing and success of Genprex's clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status; Genprex's commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

GNPX Investor Relations
investors@genprex.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

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SOURCE Genprex, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Genprex's response to the FDA's new initiative on gene therapies?

Genprex supports the FDA's initiative to expedite gene therapy development, which may facilitate faster approvals for their treatments.

How might the FDA's initiative impact Genprex (GNPX) stock?

The FDA's initiative could positively impact Genprex's stock by potentially accelerating the approval of its gene therapies.

What are Genprex's main areas of focus?

Genprex focuses on developing gene therapies for cancer and diabetes.

What technology does Genprex use for its cancer therapies?

Genprex utilizes its proprietary ONCOPREX Nanoparticle Delivery System for delivering gene therapies in cancer treatment.