Genprex Adds Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 19 2025
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Source: PRnewswire
New Clinical Trial Site: Genprex, Inc. has added Gabrail Cancer Center in Canton, Ohio, as a new site for its Acclaim-1 and Acclaim-3 clinical trials, aimed at expanding patient access to its Reqorsa® Gene Therapy for lung cancer.
FDA Fast Track Designation: Both Acclaim-1 and Acclaim-3 trials have received FDA Fast Track Designation, which is intended to expedite the development and review of therapies that address unmet medical needs.
Acclaim-1 Trial Details: The Acclaim-1 trial is a Phase 1/2 study evaluating Reqorsa in combination with AstraZeneca's Tagrisso for late-stage non-small cell lung cancer, with early results showing promising efficacy and tolerability.
Acclaim-3 Trial Details: The Acclaim-3 trial is a Phase 1/2 study assessing Reqorsa alongside Genentech's Tecentriq as maintenance therapy for extensive stage small cell lung cancer, with plans for interim analysis after enrolling 25 patients.
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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.
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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.
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