Genprex Releases Findings from Acclaim-1 Phase 1 Trial of Reqorsa Gene Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Should l Buy GNPX?
Clinical Trial Announcement: Genprex published data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy combined with Tagrisso for advanced non-small cell lung cancer (NSCLC) in the journal Clinical Lung Cancer.
Trial Results: The trial reported no Dose Limiting Toxicities (DLTs) and established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg, indicating early efficacy of Reqorsa in combination with osimertinib.
Patient Outcomes: Among the 12 patients treated, all had previously progressed on osimertinib regimens, with three experiencing prolonged time to progression, including one with a continuing partial response.
Significance of Findings: The results suggest potential benefits of Reqorsa in treating patients with advanced NSCLC who have not responded to standard osimertinib therapy.
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About GNPX
Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for patients with cancer and diabetes. The Company's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes, who have limited treatment options. Its oncology program utilizes its systemic, non-viral Oncoprex Delivery System, which uses lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor gene-expressing plasmids to cancer cells. Its oncology drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), is developed in combination with approved cancer drugs to treat Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). GPX-002 is being developed by the Company using the same construct for the treatment of both Type 1 diabetes and Type 2 diabetes. GPX-002 for Type 1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Congressman Tim Moore Invests in Gene Therapy Company GNPX Amid High Volatility
- Investment Activity: Congressman Tim Moore made multiple purchases of shares in the gene therapy company Genprex (market cap under $5 million) in 2025, totaling between $31,000 and $115,000, indicating a keen interest in high-risk small-cap investments.
- Trading Performance: Moore was recognized as the top-performing member of Congress for stock trades in 2025, achieving a 52% return, significantly outperforming the S&P 500's 16.6% gain, which underscores the effectiveness of his investment strategy.
- Company Developments: Genprex experienced notable volatility in 2025, particularly in October when its stock surged following an update on its lead drug candidate REQORSA, highlighting market interest in its research progress.
- Future Outlook: Genprex plans to meet with the FDA to request Investigational New Drug studies, which could pave the way for human clinical trials, necessitating investor attention to the high volatility associated with its clinical data releases.
See More
Genprex Advances GPX-002 Diabetes Gene Therapy Clinical Program
- Clinical Progress: Genprex has reported encouraging early results from preclinical tests in mice and non-human primates, indicating that GPX-002 rejuvenates beta cells and normalizes glucose levels, marking a potential breakthrough in diabetes treatment.
- Manufacturing Transition: The company has moved the manufacturing of GPX-002 to skilled CDMO partners to enhance production capacity and optimize delivery methods, preparing for future human clinical trials and demonstrating a commitment to product quality and efficiency.
- FDA Meeting Plans: Genprex is seeking to meet with the FDA to discuss studies needed for an IND application, indicating a proactive approach in advancing clinical trials and a focus on regulatory compliance to expedite product market entry.
- Increased Research Investment: In 2025, the company plans to ramp up research efforts for Type 2 diabetes and initiate toxicology studies, further driving clinical trial advancements and showcasing its long-term commitment and strategic positioning in the diabetes treatment market.
See More
Genprex Advances Diabetes Gene Therapy with Key Milestones Achieved in 2025
- Clinical Progress: In 2025, Genprex successfully initiated preclinical research for GPX-002 targeting Type 2 diabetes, marking a significant milestone in its diabetes gene therapy program and laying the groundwork for future human clinical trials.
- Production Transfer: The company has transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), which is expected to enhance production efficiency and accelerate the clinical development process.
- FDA Meeting Request: Genprex submitted a request to the FDA for a meeting regarding its Investigational New Drug (IND)-enabling studies, a crucial step that will provide necessary regulatory support for the smooth advancement of its clinical trials.
- Technological Innovation: GPX-002 demonstrates the ability to convert pancreatic alpha cells into functional beta-like cells, showing potential to restore normal blood glucose levels in Type 1 diabetes models, indicating a promising breakthrough in diabetes treatment.
See More
Genprex Advances Diabetes Gene Therapy with Key Milestones Achieved in 2025
- Research Expansion: Genprex has successfully initiated preclinical studies in Type 2 diabetes animal models, marking a significant milestone in its diabetes gene therapy program, which is expected to enhance the evaluation capabilities of GPX-002 in relevant disease models, thereby accelerating product development.
- Regulatory Engagement: The company plans to submit a meeting request to the FDA by the end of 2025 to discuss IND-enabling preclinical studies, with the meeting scheduled for the first quarter of 2026, which will lay the groundwork for potential human clinical trials and is strategically significant.
- Technology Transfer: Genprex has successfully transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), a move that will accelerate manufacturing processes and ensure compliance with cGMP standards, preparing the company for clinical trials.
- Product Optimization: The company is collaborating with CDMOs and research partners to optimize constructs and evaluate a second-generation alternative using a non-viral lipid nanoparticle delivery system, aiming to enhance therapeutic efficacy and safety.
See More
Genprex Reports Positive Preliminary Results for Diabetes Gene Therapy GPX-002
- Therapy Efficacy: Genprex's diabetes gene therapy GPX-002 has shown positive preliminary results in non-human primates and mice, indicating its potential to improve insulin secretion by rejuvenating exhausted beta cells, thus offering a new treatment option for Type 2 diabetes patients.
- Innovative Delivery Method: In the non-human primate study, administering GPX-002 via intraductal infusion led to steady improvements in glucose tolerance over several months, with normal glucose tolerance achieved by seven months, suggesting this method may more effectively target alpha and beta cells.
- Mouse Study Results: In Type 2 diabetic mice, GPX-002 produced strong activity signals, with glucose levels returning to normal four weeks post-treatment, further supporting the therapy's ability to restore functional beta cells and potentially addressing a larger population of diabetes patients.
- Future Research Plans: Genprex is continuing non-human primate studies and preparing for formal toxicology studies to support a future Investigational New Drug submission, demonstrating the company's ongoing commitment and potential in the diabetes treatment field.
See More
Genprex Reports Promising Preclinical Data for Diabetes Gene Therapy GPX-002
- Therapeutic Efficacy: Genprex's diabetes gene therapy candidate GPX-002 demonstrated sustained improvements in glucose tolerance and reduced insulin requirements in non-human primate and mouse models, with one primate achieving normal glucose levels months post-treatment, indicating its potential to restore pancreatic cell function.
- Clinical Trial Plans: The company is continuing preclinical testing in Type 1 and Type 2 diabetes models and plans to advance GPX-002 toward human clinical trials, including toxicology studies and a future IND submission, paving the way for commercialization.
- Positive Market Reaction: Following the report, Genprex shares rose over 5% to close at $1.80, up 0.56%, reflecting investor confidence in the therapy's potential, which may drive future funding and R&D progress for the company.
- Strategic Development Direction: The positive preclinical data not only enhances the market appeal of GPX-002 but may also support Genprex's long-term strategic development in the diabetes treatment space, helping it secure a foothold in the competitive biopharmaceutical market.
See More
Congressman Tim Moore Invests in Gene Therapy Company GNPX Amid High Volatility
- Investment Activity: Congressman Tim Moore made multiple purchases of shares in the gene therapy company Genprex (market cap under $5 million) in 2025, totaling between $31,000 and $115,000, indicating a keen interest in high-risk small-cap investments.
- Trading Performance: Moore was recognized as the top-performing member of Congress for stock trades in 2025, achieving a 52% return, significantly outperforming the S&P 500's 16.6% gain, which underscores the effectiveness of his investment strategy.
- Company Developments: Genprex experienced notable volatility in 2025, particularly in October when its stock surged following an update on its lead drug candidate REQORSA, highlighting market interest in its research progress.
- Future Outlook: Genprex plans to meet with the FDA to request Investigational New Drug studies, which could pave the way for human clinical trials, necessitating investor attention to the high volatility associated with its clinical data releases.
See More
Genprex Advances GPX-002 Diabetes Gene Therapy Clinical Program
- Clinical Progress: Genprex has reported encouraging early results from preclinical tests in mice and non-human primates, indicating that GPX-002 rejuvenates beta cells and normalizes glucose levels, marking a potential breakthrough in diabetes treatment.
- Manufacturing Transition: The company has moved the manufacturing of GPX-002 to skilled CDMO partners to enhance production capacity and optimize delivery methods, preparing for future human clinical trials and demonstrating a commitment to product quality and efficiency.
- FDA Meeting Plans: Genprex is seeking to meet with the FDA to discuss studies needed for an IND application, indicating a proactive approach in advancing clinical trials and a focus on regulatory compliance to expedite product market entry.
- Increased Research Investment: In 2025, the company plans to ramp up research efforts for Type 2 diabetes and initiate toxicology studies, further driving clinical trial advancements and showcasing its long-term commitment and strategic positioning in the diabetes treatment market.
See More
Genprex Advances Diabetes Gene Therapy with Key Milestones Achieved in 2025
- Clinical Progress: In 2025, Genprex successfully initiated preclinical research for GPX-002 targeting Type 2 diabetes, marking a significant milestone in its diabetes gene therapy program and laying the groundwork for future human clinical trials.
- Production Transfer: The company has transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), which is expected to enhance production efficiency and accelerate the clinical development process.
- FDA Meeting Request: Genprex submitted a request to the FDA for a meeting regarding its Investigational New Drug (IND)-enabling studies, a crucial step that will provide necessary regulatory support for the smooth advancement of its clinical trials.
- Technological Innovation: GPX-002 demonstrates the ability to convert pancreatic alpha cells into functional beta-like cells, showing potential to restore normal blood glucose levels in Type 1 diabetes models, indicating a promising breakthrough in diabetes treatment.
See More
Genprex Advances Diabetes Gene Therapy with Key Milestones Achieved in 2025
- Research Expansion: Genprex has successfully initiated preclinical studies in Type 2 diabetes animal models, marking a significant milestone in its diabetes gene therapy program, which is expected to enhance the evaluation capabilities of GPX-002 in relevant disease models, thereby accelerating product development.
- Regulatory Engagement: The company plans to submit a meeting request to the FDA by the end of 2025 to discuss IND-enabling preclinical studies, with the meeting scheduled for the first quarter of 2026, which will lay the groundwork for potential human clinical trials and is strategically significant.
- Technology Transfer: Genprex has successfully transferred the production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO), a move that will accelerate manufacturing processes and ensure compliance with cGMP standards, preparing the company for clinical trials.
- Product Optimization: The company is collaborating with CDMOs and research partners to optimize constructs and evaluate a second-generation alternative using a non-viral lipid nanoparticle delivery system, aiming to enhance therapeutic efficacy and safety.
See More
Genprex Reports Positive Preliminary Results for Diabetes Gene Therapy GPX-002
- Therapy Efficacy: Genprex's diabetes gene therapy GPX-002 has shown positive preliminary results in non-human primates and mice, indicating its potential to improve insulin secretion by rejuvenating exhausted beta cells, thus offering a new treatment option for Type 2 diabetes patients.
- Innovative Delivery Method: In the non-human primate study, administering GPX-002 via intraductal infusion led to steady improvements in glucose tolerance over several months, with normal glucose tolerance achieved by seven months, suggesting this method may more effectively target alpha and beta cells.
- Mouse Study Results: In Type 2 diabetic mice, GPX-002 produced strong activity signals, with glucose levels returning to normal four weeks post-treatment, further supporting the therapy's ability to restore functional beta cells and potentially addressing a larger population of diabetes patients.
- Future Research Plans: Genprex is continuing non-human primate studies and preparing for formal toxicology studies to support a future Investigational New Drug submission, demonstrating the company's ongoing commitment and potential in the diabetes treatment field.
See More
Genprex Reports Promising Preclinical Data for Diabetes Gene Therapy GPX-002
- Therapeutic Efficacy: Genprex's diabetes gene therapy candidate GPX-002 demonstrated sustained improvements in glucose tolerance and reduced insulin requirements in non-human primate and mouse models, with one primate achieving normal glucose levels months post-treatment, indicating its potential to restore pancreatic cell function.
- Clinical Trial Plans: The company is continuing preclinical testing in Type 1 and Type 2 diabetes models and plans to advance GPX-002 toward human clinical trials, including toxicology studies and a future IND submission, paving the way for commercialization.
- Positive Market Reaction: Following the report, Genprex shares rose over 5% to close at $1.80, up 0.56%, reflecting investor confidence in the therapy's potential, which may drive future funding and R&D progress for the company.
- Strategic Development Direction: The positive preclinical data not only enhances the market appeal of GPX-002 but may also support Genprex's long-term strategic development in the diabetes treatment space, helping it secure a foothold in the competitive biopharmaceutical market.
See More
