Genprex Inc. (NASDAQ: GNPX) Receives Orphan Drug Designation for Immunogene Therapy for Treatment of SCLC

NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- viaInvestorWire—Genprex Inc. (NASDAQ: GNPX)today announces its placement in an editorial published byNetworkNewsWire("NNW"), one of 50+ trusted brands within theInvestorBrandNetwork(“IBN”), a multifaceted financial news and publishing company for private and public entities.

To view the full publication, “Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation,” please visit:https://nnw.fm/619wq

More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition.

This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month,Genprex Inc. (NASDAQ: GNPX)was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC).

Genprex 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 systemic, nonviral ONCOPREX(R) Nanoparticle Delivery System, which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The company’s lead product candidate, REQORSA(R) (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”). Each of Genprex’s three lung cancer clinical programs has received a Fast Track Designation from the Food and Drug Administration (“FDA”), and its SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses 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 may be 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 about the company, visitwww.Genprex.com.

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