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

 

Source:  Genprex, Inc. March 3/23/2023

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

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.