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Genprex Collaborators to Present Positive Preclinical Data on Diabetes Gene Therapy at the ASGCT 28th Annual Meeting
Prnewswire· 2025-04-29 11:30
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].
Genprex Signs Exclusive Technology License Agreement with New York University Langone Health for the Treatment of Mesothelioma
Prnewswire· 2025-04-28 11:30
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].
Genprex Selected to Present Trial Design of Acclaim-3 Clinical Trial Evaluating Reqorsa® Gene Therapy in Small Cell Lung Cancer at 2025 ASCO Annual Meeting
Prnewswire· 2025-04-24 12:15
Presentation to Highlight Genprex's Study of Reqorsa Gene Therapy in Combination with Tecentriq® for the Treatment of Extensive Stage Small Cell Lung Cancer AUSTIN, Texas, April 24, 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 it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual M ...
Genprex Announces Research Collaborators' Abstract Published in Cancer Research Supplement Proceedings
Prnewswire· 2025-04-22 12:15
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]
Genprex(GNPX) - 2024 Q4 - Annual Report
2025-03-31 22:20
Clinical Trials and Research - The company is developing REQORSA® gene therapy for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC), with a recommended Phase 2 dose of 0.12 mg/kg established after the Phase 1 trial [486]. - In the Phase 1 portion of the Acclaim-1 trial, one patient achieved a partial remission after 47 courses of treatment, demonstrating prolonged progression-free survival (PFS) of approximately 35 months [486]. - The Acclaim-1 trial is expected to enroll approximately 33 patients who have progressed on Tagrisso or Tagrisso-containing regimens, with an interim analysis planned after treating 19 patients [486]. - The FDA has granted Fast Track Designation for the combination of REQORSA and Tagrisso in NSCLC patients who have progressed on Tagrisso treatment [487]. - The Acclaim-3 trial is currently enrolling patients, with an expected enrollment of approximately 50 patients, focusing on the 18-week progression-free survival rate as a primary endpoint [491]. - The Acclaim-2 trial has been closed due to slow enrollment, with no patients currently receiving study treatment [490]. - The company is collaborating with MD Anderson to identify biomarkers that may enhance patient screening and enrollment for clinical trials [485]. - The company plans to complete interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial by the end of 2025 [523]. - The company may face delays in clinical trials due to various factors, including competition for patients and transitions to new third-party CDMOs [524]. Financial Performance - Research and development (R&D) expenses decreased by $7,081,159, or 40%, to $10,535,446 for the year ended December 31, 2024, compared to $17,616,605 in 2023 [509]. - General and administrative (G&A) expenses decreased by $2,793,257, or 21%, to $10,632,028 for the year ended December 31, 2024, compared to $13,425,285 in 2023 [510]. - Net loss for the fiscal year ended December 31, 2024, was $21,111,163, a decrease of $9,749,298, or 32%, from a net loss of $30,860,461 in 2023 [513]. - As of December 31, 2024, the accumulated deficit was $154,799,443, with no revenue generated from product sales since inception [515]. - Cash balance as of December 31, 2024, was $1,601,660, with subsequent net proceeds of approximately $6.0 million received through the ATM Agreement [522]. - Net cash used in operating activities decreased by $7,589,515, or 31%, from $24,738,603 in 2023 to $17,149,088 in 2024 due to expense reduction strategies [529]. - Net cash provided by investing activities changed from a net cash used of $71,214 in 2023 to a net cash provided of $1,166 in 2024, resulting in a net change of $72,380 [530]. - Net cash provided by financing activities increased by $1,418,576, or 13%, from $10,593,377 in 2023 to $12,011,953 in 2024, attributed to differences in capital raising activities [531]. - The net decrease in cash for the year ended December 31, 2024, was $5,135,969, compared to a decrease of $14,216,440 in 2023 [529]. Future Outlook and Funding - The company expects to fund operations through equity offerings, ATM drawdowns, and potential debt financing, anticipating the need for additional capital to support ongoing clinical trials [523]. - R&D expenses are expected to increase in the future as the company advances product candidates through clinical trials and expands research programs [504]. - The company anticipates needing additional fundraising activities and cash on hand by the second quarter of 2025 to meet fixed cash obligations related to clinical studies [526]. - The company expects insufficient cash to cover ongoing clinical trials and research and development programs through fiscal year 2025 without raising additional working capital [526]. - Future capital requirements will depend on various factors, including development costs, manufacturing expenses, and costs associated with being a public company [528]. - The company may need to use liquidity for acquisitions or additional capital to fund newly acquired operations, which could lead to dilution for existing security holders [527]. - The company has ongoing obligations related to the Acclaim clinical trials, which may require adjustments to its operating plan if cash is insufficient [526]. - The company reduced headcount in R&D from 16 employees at December 31, 2023, to 10 employees at December 31, 2024, as part of expense reduction strategies [509]. - The company has reduced its workforce from 28 employees at December 31, 2023, to 16 employees at December 31, 2024, as part of its expense reduction strategies [529].
Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® Gene Therapy for the Treatment of Lung Cancer at the 2025 AACR Annual Meeting
Prnewswire· 2025-03-26 12:15
Core Viewpoint - Genprex, Inc. announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, targeting KRASG12C mutant non-small cell lung cancer (NSCLC), which may provide a new treatment option for patients resistant to Ras inhibitors [1][2]. Group 1: Research and Development - The upcoming presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting will showcase preclinical data on Reqorsa® Gene Therapy [1]. - The study focuses on overcoming acquired resistance to sotorasib (Lumakras®), the first FDA-approved KRAS inhibitor, in KRASG12C mutant NSCLC [3]. - TUSC2, the active component in Reqorsa, has shown multifunctional activity, including inhibiting cancer cell growth and activating immune responses [3][4]. Group 2: Clinical Efficacy - TUSC2 transfection significantly reduced colony formation and increased apoptosis in acquired resistance (AR) cell lines [4]. - Reqorsa demonstrated a strong antitumor effect in mouse xenografts and patient-derived xenograft (PDX) models, outperforming sotorasib alone [4][5]. - A synergistic effect was observed when combining Reqorsa with sotorasib in treating TC314AR PDX tumors [4]. Group 3: Product Information - Reqorsa (quaratusugene ozeplasmid) is a gene therapy that delivers the TUSC2 gene using a non-viral lipid-based nanoparticle system, specifically targeting cancer cells [6][8]. - Laboratory studies indicate that TUSC2 uptake in tumor cells is significantly higher than in normal cells, ranging from 10 to 33 times [7]. 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 [8]. - The company is advancing its pipeline of gene therapies and has received Fast Track Designation from the FDA for its lung cancer programs [8].
Genprex Collaborators Selected to Present Positive Preclinical Data on Diabetes Gene Therapy at the 2025 American Diabetes Association 85th Scientific Sessions
Prnewswire· 2025-03-25 12:15
Core Viewpoint - Genprex, Inc. is advancing its diabetes gene therapy program, GPX-002, which shows promise for treating both Type 1 and Type 2 diabetes, and will present positive preclinical data at the upcoming 2025 American Diabetes Association Scientific Session [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 has established a wholly-owned subsidiary, Convergen Biotech, to concentrate on diabetes program development [2]. Research and Development - GPX-002 is designed to modify the disease process in diabetes, potentially eliminating the need for daily blood glucose monitoring and insulin therapy [2]. - The therapy employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly into the pancreatic duct, with preclinical studies indicating restored normal blood glucose levels in Type 1 diabetes models [4][6]. - For Type 2 diabetes, GPX-002 is believed to rejuvenate and replenish exhausted beta cells [4][6]. Upcoming Presentations - Genprex's collaborators will present several abstracts at the 85th Scientific Sessions, including topics on lipid nanoparticles for transfection of islets and recombinant AAV-mediated gene therapy for diabetes [3][4].
Genprex to Participate at BIO Europe Spring 2025
Prnewswire· 2025-03-04 13:15
Core Viewpoint - Genprex, Inc. is actively participating in BIO Europe Spring 2025 to showcase its gene therapies for cancer and diabetes, highlighting its commitment to developing innovative treatments for patients with limited options [1][2][3] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing advanced technologies to deliver disease-fighting genes [4] - 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), both of which have received Fast Track Designation from the FDA [4] - Genprex's diabetes gene therapy, GPX-002, aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin, addressing both Type 1 and Type 2 diabetes [4] Conference Participation - Key executives, including Ryan Confer and Thomas Gallagher, will be attending BIO Europe Spring 2025 in Milan, Italy, to engage with industry groups and provide insights into the company's gene therapies [2][3] - The conference is expected to attract over 3,700 executives from biotech, pharma, and finance sectors, facilitating more than 20,000 one-on-one meetings [3]
Genprex Advances Diabetes Program with Addition of Research Focused on Non-Viral Delivery System
Prnewswire· 2025-02-19 13:15
Core Insights - Genprex, Inc. is advancing its diabetes program through a strategic collaboration with a CDMO to explore a non-viral lipid nanoparticle delivery system for its diabetes gene therapy drug candidate [1][2] - The collaboration aims to optimize next-generation constructs and positions Genprex as a thought leader in the diabetes market, which currently lacks disease-modifying therapies [2][3] - The company's GPX-002 therapy has shown promising results in preclinical studies, maintaining glucose control for approximately 120 days in Type 1 diabetes models, suggesting potential for multiple treatments with a non-viral delivery system [3] 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 diabetes gene therapy approach involves using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas, transforming alpha cells into functional beta-like cells [6] Industry Context - As of 2024, approximately 38.4 million Americans have diabetes, with 10% having Type 1 diabetes and 90-95% having Type 2 diabetes [4] - The global diabetes prevalence is projected to rise from 537 million in 2021 to 783 million by 2045, highlighting the urgent need for effective treatments [4] - Diabetes caused over 6.7 million deaths globally in 2021 and resulted in approximately $966 billion in health expenditures, indicating a significant economic burden [4]
Genprex Collaborators Find NPRL2 Gene Therapy Using Oncoprex® Delivery System is a Potential Treatment for Anti-PD1 Resistant Non-Small Cell Lung Cancer
Prnewswire· 2025-02-13 13:15
Core Insights - Genprex, Inc. announced significant findings regarding NPRL2 gene therapy's effectiveness in treating anti-PD1 resistant non-small cell lung cancer (NSCLC) using a non-viral delivery system [1][2][3] - The study demonstrated that NPRL2 gene therapy alone produced a dramatic antitumor effect, while pembrolizumab (Keytruda®) was ineffective on its own [2][3] - The Oncoprex® Delivery System, which utilizes lipid nanoparticles, allows for the intravenous delivery of tumor suppressor genes, minimizing toxicity risks associated with viral systems [1][4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its non-viral Oncoprex® Delivery System [5][6] - The company's lead product, Reqorsa® Gene Therapy, is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [5][6] - Genprex's oncology programs have received Fast Track Designation from the FDA, and the SCLC program has received Orphan Drug Designation [6] Research Findings - The NPRL2 gene therapy showed greater antitumor effects in humanized mice compared to non-humanized NSG mice, indicating the role of the immune system in its efficacy [3] - The therapy targets KRAS/STK11 mutant tumors, which are known to be resistant to conventional treatments, suggesting potential applicability to approximately 30% of NSCLCs with KRAS mutations [3]