Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is commending the U.S. Food and Drug Administration (“FDA”) and the organization’s recent initiative, which is designed to expedite the development of gene therapies for patients with rare diseases. The government agency has announced that it will support using biomarkers as substitutes for other biological indicators in gene therapy clinical trials, which should result in a faster approval process. Genprex is advancing its novel gene therapies for large patient populations with cancer and diabetes, two groups that currently have limited treatment options. “The FDA’s efforts to streamline the regulatory process will help bring much-needed therapies to patients more efficiently,” said Genprex chair, president and CEO Rodney Varner in the press release. “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.”
To view the full press release, visit https://ibn.fm/dsL9j
About Genprex Inc.
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, which 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, nonviral ONCOPREX(R) 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 then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. 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 (“Pdx1”) and MafA (“MafA”) genes to the pancreas. In models of type a 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 w diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. For more information, please visit the company’s website at www.Genprex.com
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