Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, has received Fast Track Designation (“FTD”) from the U.S. Food and Drug Administration (“FDA”) for its lead drug candidate, REQORSA(R) Immunogene Therapy; the designation applies when used in combination with Genentech Inc.’s Tecentriq(R) to treat 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. According to the announcement, this is the third FTD granted to Genprex’s REQORSA. The company noted that it anticipates enrolling the first patient in its Acclaim-3 clinical trial, which is a phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. “We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,” said Genprex president, chair and CEO Rodney Varner in the press release. “This is another exciting achievement in our REQORSA 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.”
To view the full press release, visit https://ibn.fm/0xQPB
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 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 tumor suppressor proteins that are deficient in the tumor. 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 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, please visit the company’s website at www.Genprex.com.
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