Core Viewpoint - Genprex, Inc. has received patent allowances for its lead drug candidate, Reqorsa® Gene Therapy, in combination with immune checkpoint inhibitors, enhancing its intellectual property portfolio for oncology treatments [1][2][3] Intellectual Property Developments - The U.S. Patent and Trademark Office and the European Patent Office have issued Notices of Allowance for patents covering the use of Reqorsa in combination with PD-L1 and PD-1 antibodies, respectively, with both patents set to expire in 2037 at the earliest [1][3] - Genprex has also secured patents for Reqorsa in combination with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel [3] Clinical Trial Information - The Acclaim-3 study is a Phase 1/2 clinical trial evaluating Reqorsa in combination with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC) [5] - The Acclaim-3 trial has received FDA Fast Track Designation and Orphan Drug Designation, indicating its potential significance in treating this patient population [5] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a non-viral Oncoprex® Delivery System for its gene therapies [6] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received FDA Fast Track Designation [6]

Core Viewpoint - Genprex, Inc. has presented promising preclinical research on its diabetes gene therapy candidate GPX-002, demonstrating its potential to improve glucose homeostasis by reprogramming alpha cells into beta-like cells, as showcased at the 2025 American Diabetes Association Scientific Session [1][2]. Group 1: Research Findings - The research indicates that alpha cells in animal models of Type 1 diabetes (T1D) can transdifferentiate into beta-like cells after being treated with GPX-002, maintaining improved glucose control for three months [2][6]. - The gene therapy utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes directly into the pancreatic duct, effectively converting alpha cells into insulin-secreting beta-like cells without the need for immunosuppression in mouse models [3][12]. - In non-human primate studies, the infusion of rAAV resulted in improved glucose tolerance and reduced insulin requirements one month post-infusion, with ongoing evaluations of immune responses to the therapy [5][8]. Group 2: Clinical Development - Genprex is advancing GPX-002 for both Type 1 and Type 2 diabetes, with the same gene therapy approach applied to both conditions, aiming to rejuvenate exhausted beta cells in Type 2 diabetes [9][12]. - The company is currently conducting preclinical studies to gather additional data on the efficacy of GPX-002 after six months of immunosuppression [8][9]. - The therapy is designed to be administered via a routine endoscopy procedure in humans, enhancing its potential for clinical application [9]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, collaborating with leading institutions to advance its drug candidates [10][11]. - The company’s oncology program includes the Oncoprex® Delivery System, which encapsulates gene-expressing plasmids for intravenous administration, targeting tumor cells [11]. - Genprex aims to provide new treatment options for patients with limited alternatives, leveraging its gene therapy technologies [10].

Novel Diabetes Gene Therapy Shows Potential for Re-Dosing Using Non-Viral Delivery System AUSTIN, Texas, June 23, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, at the 2025 American ...

Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [4] - The company utilizes a systemic, non-viral Oncoprex® Delivery System to administer gene therapies [4] - Genprex's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [4] - The company has received Fast Track Designation from the FDA for its lung cancer programs and Orphan Drug Designation for its SCLC program [4] Upcoming Events - Genprex will participate in the BIO 2025 International Convention from June 16-19, 2025, in Boston, Massachusetts [1][3] - Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing, will be available for one-on-one meetings during the conference [2] Technology and Innovation - Genprex's diabetes gene therapy approach involves a novel infusion process using an AAV vector to deliver Pdx1 and MafA genes to the pancreas [4] - In Type 1 diabetes models, GPX-002 transforms alpha cells into functional beta-like cells capable of producing insulin [4] - For Type 2 diabetes, GPX-002 is believed to rejuvenate and replenish exhausted beta cells [4] Industry Context - The BIO International Convention is the largest biotechnology event, attracting 20,000 industry leaders globally [3] - Genprex collaborates with world-class institutions to develop its drug candidates and expand its gene therapy pipeline [4]

Core Viewpoint - Genprex, Inc. is advancing its diabetes gene therapy candidate GPX-002, which shows promise in treating both Type 1 and Type 2 diabetes, as evidenced by positive preclinical data presented at the ASGCT Annual Meeting [1][2]. Group 1: Research and Development - GPX-002 utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes, converting alpha cells into beta-like cells that secrete insulin, effectively reversing diabetes in mouse models without the need for immunosuppression [2][3]. - The therapy has been tested in cynomolgus macaques with streptozotocin-induced diabetes, demonstrating improved glucose tolerance and reduced insulin requirements one month post-infusion [4][5]. - Ongoing preclinical studies are evaluating the long-term efficacy of GPX-002 after six months of immunosuppression in non-human primate models for both Type 1 and Type 2 diabetes [6]. Group 2: Presentation Details - The oral presentation at the ASGCT Annual Meeting was titled "Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model," presented by Dr. Hannah Rinehardt [2]. - The presentation highlighted the challenges of managing immune responses to the therapy, indicating that temporary immunosuppression can effectively prevent anti-viral immunity but may need to be extended beyond three months [4][5]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, utilizing advanced technologies to deliver disease-fighting genes [8]. - The company’s approach for diabetes involves a novel infusion process using an AAV vector to directly administer therapeutic genes into the pancreas, with the potential for routine endoscopic procedures in humans [7][8].

Core Viewpoint - Genprex, Inc. has announced a new Sponsored Research Agreement (SRA) with the University of Pittsburgh to further study its gene therapy GPX-002 for Type 1 and Type 2 diabetes in animal models, following the completion of a previous two-year agreement [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [5][6]. - The company’s lead product candidate, Reqorsa® Gene Therapy, is under evaluation in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [5]. Research and Development - The new SRA with the University of Pittsburgh will sponsor preclinical studies of GPX-002, which has shown promising results in reducing insulin requirements and improving glucose tolerance in animal models of diabetes [2][3]. - GPX-002 employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas, aiming to transform alpha cells into functional beta-like cells in Type 1 diabetes and rejuvenate exhausted beta cells in Type 2 diabetes [3][6]. Market Context - As of 2024, approximately 38.4 million Americans have diabetes, with 10% having Type 1 diabetes and 90-95% having Type 2 diabetes. The global diabetes population is projected to rise from 537 million in 2021 to 783 million by 2045 [4]. - Diabetes caused over 6.7 million deaths globally in 2021 and resulted in approximately $966 billion in health expenditures, reflecting a significant increase over the past fifteen years [4].

Core Viewpoint - Genprex, Inc. announced positive preclinical data for Reqorsa® Gene Therapy, demonstrating its robust anti-tumor effects in KRASG12C mutant non-small cell lung cancer (NSCLC), both alone and in combination with LUMAKRAS® [1][2]. Group 1: Preclinical Data Presentation - The positive preclinical data was presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting the therapeutic potential of REQORSA in treating Ras inhibitor resistant lung cancer [1][2]. - The poster titled "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy" showcased that TUSC2 gene therapy effectively overcomes acquired resistance to sotorasib in mouse xenografts [3]. Group 2: Efficacy of Reqorsa - TUSC2 transfection significantly reduced colony formation and increased apoptosis in acquired resistance cell lines, indicating strong anti-tumor efficacy [3]. - REQORSA alone showed a strong anti-tumor effect on TC314AR PDXs, while sotorasib alone exhibited no significant activity [3]. - A synergistic effect was observed when combining REQORSA with sotorasib, enhancing tumor control compared to either treatment alone [3]. Group 3: Technology and Delivery System - Reqorsa consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles, specifically targeting cancer cells while minimizing uptake by normal tissue [5]. - Laboratory studies indicated that the uptake of TUSC2 in tumor cells after REQORSA treatment was 10 to 33 times higher than in normal cells [5]. Group 4: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene administration [6][7]. - The company is advancing its pipeline of gene therapies and has received Fast Track Designation from the FDA for its lung cancer clinical programs [7].

Core Viewpoint - Genprex, Inc. has announced the presentation of positive preclinical data for its diabetes gene therapy candidate GPX-002 at the upcoming ASGCT Annual Meeting, highlighting the potential of gene therapy as a curative treatment for diabetes [1][2]. Group 1: Research and Development - The oral presentation will focus on the immune modulation and reprogramming of alpha cells to beta-like cells in a diabetic non-human primate model, showcasing the effectiveness of the rAAV gene therapy approach [3]. - The study demonstrated that retrograde intraductal infusion of rAAV6 can convert alpha cells into insulin-secreting beta-like cells, reversing diabetes in mouse models [4]. - One month post-infusion, non-human primates exhibited improved glucose tolerance and reduced insulin requirements, indicating the therapy's durable effects [5]. Group 2: Immune Response Management - The research evaluated the immune response to direct infusion of rAAV into the pancreatic duct and how to manage potential anti-viral immunity, which can hinder gene therapy success [4][5]. - Temporary immunosuppression using a combination of rituximab, rapamycin, and steroids was largely effective in preventing anti-viral immune responses, allowing sustained therapeutic effects [6]. Group 3: Product Overview - GPX-002 is being developed for both Type 1 and Type 2 diabetes, utilizing an AAV vector to deliver Pdx1 and MafA genes directly into the pancreatic duct [7]. - In Type 1 diabetes, GPX-002 aims to transform alpha cells into functional beta-like cells, while in Type 2 diabetes, it is believed to rejuvenate exhausted beta cells [7]. Group 4: Company Background - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, collaborating with leading institutions to advance its drug candidates [8].

Core Viewpoint - Genprex, Inc. has signed an exclusive patent license agreement with NYU Langone Health for Reqorsa® Gene Therapy, which is being investigated as a treatment for mesothelioma, thereby expanding its oncology portfolio and clinical development pipeline [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System to administer disease-fighting genes [8][9]. - The company collaborates with leading research institutions to advance its gene therapy candidates [8]. Product Details - Reqorsa® Gene Therapy (quaratusugene ozeplasmid) is designed to deliver the TUSC2 gene to cancer cells, with studies showing a 10 to 33 times higher uptake in tumor cells compared to normal cells [7][9]. - The therapy has demonstrated significant decreases in cell proliferation and invasion, along with increased apoptosis in malignant pleural mesothelioma cell lines [4]. Research and Development - Positive preclinical data for Reqorsa was presented at the 2024 EORTC-NCI-AACR Symposium, indicating its potential effectiveness against mesothelioma [2][4]. - Genprex has established a Mesothelioma Clinical Advisory Board to support its preclinical oncology program, consisting of four renowned researchers [5]. Market Context - Mesothelioma is a rare cancer with approximately 3,000 new cases diagnosed annually in the U.S., primarily affecting the pleura, which accounts for 80-90% of cases [6]. - The life expectancy for pleural mesothelioma is around 18 months, with a 3-year survival rate of 23% for treated patients [6].

Core Viewpoint - Genprex, Inc. announced the publication of positive preclinical data on its lead drug candidate, Reqorsa® Gene Therapy, for treating KRASG12C mutant non-small cell lung cancer (NSCLC) [1][2][3] Group 1: Research and Development - The abstract detailing the preclinical data was published in the online Proceedings supplement of Cancer Research [1] - The data will be presented at the 2025 AACR Annual Meeting, highlighting advances in cancer treatment [2][3] - The study demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes acquired resistance to sotorasib in KRASG12C mutant NSCLC mouse xenografts [4][5][6] Group 2: Mechanism and Efficacy - Acquired resistance to Lumakras® (sotorasib) presents a significant challenge in treating KRASG12C mutant NSCLC, necessitating alternative strategies [4] - TUSC2 gene therapy exhibits multifunctional activity, inhibiting downstream signaling pathways, inducing tumor cell death, and activating immune responses [4][5] - REQORSA alone showed significant antitumor efficacy, and a synergistic effect was observed when combined with sotorasib [5][6] Group 3: Product Information - Reqorsa® Gene Therapy consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles [7] - The therapy is designed to specifically target cancer cells while minimizing uptake by normal tissue, with laboratory studies showing 10 to 33 times greater uptake in tumor cells compared to normal cells [8] Group 4: Company Overview - Genprex, Inc. is focused on developing gene therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System [9] - The company’s lead product candidate, Reqorsa, is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [9]