Genprex targets non-small cell lung cancer and diabetes via gene therapy

Focused on developing life-changing therapies for patients with cancer and diabetes  Advancing lead product REQORSA immunogene therapy for non-small cell lung cancer Struck licensing agreement with the University of Pittsburgh for diabetes gene therapy What Genprex does: Genprex Inc (NASDAQ:GNPX) is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.  The Austin, Texas company’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations who currently have limited treatment options.  The company’s lead product candidate REQORSA immunogene therapy is being developed for non-small cell lung cancer (NSCLC). The active ingredient in REQORSA is the TUSC2 gene, a tumor suppressor gene.  REQORSA uses the company’s unique, proprietary ONCOPREX nanoparticle delivery system which provides cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanoparticles. Those nanoparticles are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.  More specifically, REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. The US Food and Drug Administration (FDA) in early 2020 granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca PLC’s (NYSE:AZN) Tagrisso (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso alone. How is it doing: Genprex headed into 2021 with $40 million in the bank -- a sufficient runway to help fund two upcoming Acclaim trials to evaluate REQORSA for NSCLC. The company, which notes that lung cancer is the leading cause of cancer deaths worldwide, plans to launch both trials in the first half of 2021. Acclaim-1 is a Phase 1/2 combination clinical trial using REQORSA combined with AstraZeneca’s Tagrisso in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. Tagrisso, which has had worldwide sales in the billions of dollars, is currently AstraZeneca’s highest grossing product for the treatment of NSCLC patients with EFGR mutations.  Acclaim-2 is a Phase 1/2 combination clinical trial using REQORSA combined with Merck & Co Inc’s (NYSE:MRK) Keytruda (pembrolizumab) in NSCLC patients who are low expressors of PD-L1 -- a protein that acts as a kind of “brake” to keep the body's immune responses under control.  While Genprex gears up for both trials, preclinical data for REQORSA will be featured in two presentations at the six-day virtual annual meeting of the American Association for Cancer Research, starting on April 9, 2021. The preclinical data will highlight REQORSA's use in chemotherapy and immunotherapies, as well as in combination with Tagrisso. And in preparation for the trials, the company has formed a Clinical Advisory Board (CAB) to support its oncology and diabetes development programs. In February, Genprex named four individuals to the CAB, including Dr Michael Morse, a professor of medicine in the Division of Medical Oncology and professor in the Department of Surgery at Duke University Medical Center. Aside from lung cancer studies, the company has signed a licensing agreement with the University of Pittsburgh for a diabetes gene therapy that could have the potential to cure Type 1 and Type 2 diabetes. The gene therapy, developed at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, allowing them to replenish insulin levels. Meanwhile, Genprex has joined an elite group of 3,000 publicly listed companies with the largest market capitalizations on the NASDAQ and New York Stock Exchange. Inclusion in the Russell 3000 Index has increased Genprex’s visibility among institutional investors, money managers, and index funds. Inflection points: Initiate both Acclaim trials in 1H 2021 Advance licensing agreement with the University of Pittsburgh for diabetes gene therapy What the boss says: “We achieved many significant milestones in 2020 that have set the stage for a transformational 2021,” Genprex CEO Rodney Varner told shareholders recently. “The primary focus this past year was on the preparation for our two lead clinical trials in non-small cell lung cancer.” He added: “Additionally, the $40 million-plus in capital infusions in 2020 have provided us with a strong balance sheet as 2021 begins. We are grateful for the confidence and support of our shareholders and look forward to executing on our strategies to achieve a number of potentially value-creating milestones.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham