Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, has enrolled and dosed the first patient in the phase 2a expansion portion of its Acclaim-1 clinical study of Reqorsa(R) therapy (quaratusugene ozeplasmid). The study combines Genprex’s proprietary lead product candidate with AstraZeneca’s Tagrisso(R) to treat patients with late-stage non-small cell lung cancer (“NSCLC”). An open-label, multicenter phase 1/2 clinical trial, the Accliam-1 trial has completed its phase 1 component and is moving on to phase 2. The company anticipates enrolling an estimated 66 patients in phase 2a, with one-half of the study participants receiving Tagrisso treatment alone and the other half receiving Tagrisso treatment and chemotherapy; the study will determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints.
There will be an interim analysis following the treatment of 19 patients in each cohort. The company plans to enroll an estimated 74 patients in the phase 2b randomized portion of the study; those patients will be randomized to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy with the primary endpoint of the phase 2b study being progression-free survival. Genprex plans to complete enrollment of phase 2a expansion study by the end of 2024.“Advancing Acclaim-1 marks an important milestone for Genprex,” said Genprex president, chairman and CEO Rodney Varner in the press release. “We are proud of the progress we have made thus far and are encouraged by REQORSA’s potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients.”
To view the full press release, visit https://ibn.fm/D0muh
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 that 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 administered intravenously, where it is taken up by tumor cells that then 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”). Each of Genprex’s three lung cancer clinical programs has received a fast-track designation from the Food and Drug Administration for the treatment of that patient population, and Genprex’s 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 (“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 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, please visit the company’s website at www.Genprex.com.
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