Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, is reporting results from the phase 1 portion of its Acclaim-1 phase 1/2 clinical trial. The trial is designed to evaluate Genprex’s proprietary REQORSA(R), used in combination with Tagrisso(R) (osimertinib) for the treatment of late-stage non-small cell lung cancer (“NSCLC”). According to the report, results show that REQORSA was generally well tolerated with no dose-limiting toxicities. Based on the report, the Safety Review Committee (“SRC”) has determined that the recommended phase 2 dose of REQORSA will be 0.12 mg/kg, which was the highest dose level delivered in the phase 1 portion of the trial and is twice the highest dose level delivered in a previous trial; the SRC also recommended the trial advance to phase 2. The company anticipates that phase 2 will begin in Q3 2023. “We are proud of the notable progress we made during the phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the phase 2 expansion portion of the trial is another validation for our REQORSA development program,” said Genprex president and chair Rodney Varner in the press release. “As we move into the phase 2 expansion portion of the trial, we remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical need.”
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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, 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 taken up by tumor cells that express tumor suppressor proteins which 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 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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