BioMedNewsBreaks – Genprex Inc. (NASDAQ: GNPX) Looks Forward to Acclaim-3 Trial on Heels of Receipt of FDA FTD and ODD Designations
Genprex (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes. The company recently announced that the United States Food and Drug Administration (“FDA”) had granted Orphan Drug Designation (“ODD”) to its lead drug candidate, REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (“SCLC”). The receipt of the ODD followed the FDA’s granting of Fast Track Designation (“FTD”) for REQORSA Immunogene Therapy in combination with Tecentriq in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. “With the receipt of the latest FTD and the orphan drug status, Genprex is looking forward to initiating the Acclaim-3 clinical trial, expected in the fourth quarter of 2023,” a recent article reads. “We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC,” Rodney Varner, president, chairman and CEO of Genprex, was quoted as saying. “This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track Designation underscores the great need for better treatment options for patients with SCLC, ES-SCLC and non-small cell lung cancer.”
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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 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, non-viral 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, visit the company’s website at www.Genprex.com.
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