Genprex (NASDAQ: GNPX), a gene therapy company, recently received U.S. FDA Fast Track Designation (“FTD”) for its lead product candidate, REQORSA(R) immunogene therapy, in combination with Tecentriq(R), a cancer immunotherapy treatment developed and sold by Genentech, Inc., in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. “The FTD is for the company’s Acclaim-3 patient population, and Genprex expects to initiate its Acclaim-3 clinical trial by enrolling the first patient in the third quarter of 2023… The company previously received two other FTDs. In 2020, Genprex announced that the FDA had granted FTD for its REQORSA therapy in combination with AstraZeneca’s (NASDAQ: AZN) Tagrisso(R) in patients with late-stage non-small cell lung cancer (‘NSCLC’) whose disease has progressed after treatment with Tagrisso. Later, in 2022, the company received its second FTD for REQORSA in combination with Merck & Co Inc.’s (NYSE: MRK) Keytruda(R) in patients whose disease progressed after treatment with Keytruda,” explains a recent article. “This is another exciting achievement in our REQORSA drug development program, which further validates REQORSA’s potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC,” Rodney Varner, chairman, president and CEO of Genprex, is quoted as saying.
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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 proprietary, 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 have 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 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, visit the company’s website at www.Genprex.com.
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