Welcome to our dedicated page for Genprex news (Ticker: GNPX), a resource for investors and traders seeking the latest updates and insights on Genprex stock.
Genprex, Inc. develops clinical-stage gene therapies for cancer and diabetes, with recurring updates centered on Reqorsa® Gene Therapy (quaratusugene ozeplasmid) and its diabetes gene therapy candidate Pdx1/MafA, also referred to as GPX-002. Reqorsa uses a non-viral, lipid-based nanoparticle delivery approach for a TUSC2 gene-expressing plasmid and is being developed with approved cancer drugs for non-small cell lung cancer and small cell lung cancer.
Company news commonly covers patent grants and licensed intellectual property for Reqorsa combinations with PD-1 and PD-L1 antibodies, biomarker research involving TROP2 and PTEN, preclinical and clinical data presentations, sponsored research with UT MD Anderson, oncology trial references such as Acclaim-1 and Acclaim-3, diabetes preclinical research, industry conference participation and Nasdaq compliance updates.
Genprex (NASDAQ: GNPX) announced that its research collaborators will present positive preclinical data for GPX-002, their diabetes gene therapy drug candidate, at the 2025 American Diabetes Association 85th Scientific Sessions in Chicago.
GPX-002 is being developed as a potential disease-modifying therapy for both Type 1 and Type 2 diabetes, aiming to eliminate the need for daily blood glucose monitoring and insulin replacement therapy. Recent company developments include:
- Signing an amended license agreement for multiple diabetes gene therapy technologies
- Formation of Convergen Biotech subsidiary focused on diabetes program development
- Addition of research on re-dosable non-viral delivery systems
Two presentations are scheduled: a poster presentation on lipid nanoparticles for islet cell transfection, and an oral presentation on AAV-mediated gene therapy treatment in non-human primates with streptozotocin-induced diabetes.
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, has announced its participation in BIO Europe Spring 2025, scheduled for March 17-19 in Milan, Italy. Ryan Confer, President and CEO, and Thomas Gallagher, Senior VP of Intellectual Property and Licensing, will represent the company.
The executives will be available for one-on-one meetings with industry groups to discuss Genprex's gene therapies for cancer and diabetes. 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.
Interested parties can schedule meetings through the conference portal or by contacting Genprex's Investor Relations at investors@genprex.com.
Genprex (NASDAQ: GNPX) announced advancement in its diabetes program through a strategic collaboration with a CDMO partner to research a non-viral lipid nanoparticle delivery system for its diabetes gene therapy drug candidate. This alternative approach represents a second-generation development, separate from existing preclinical programs.
The company's current diabetes treatment, GPX-002, uses an AAV vector containing Pdx1 and MafA genes administered into the pancreatic duct. While effective, viral delivery systems cannot be readministered due to immune responses. The non-viral approach could enable multiple treatments, potentially optimizing patient outcomes.
Recent preclinical studies showed GPX-002's effectiveness in Type 1 NOD mouse models, maintaining glucose control for approximately 120 days, significantly longer than the 17-day median observed with traditional islet cell transplants. The therapy is being developed for both Type 1 and Type 2 diabetes, working by transforming pancreatic alpha cells into functional beta-like cells.
Genprex (NASDAQ: GNPX) has announced significant developments in its diabetes gene therapy program. The company has signed an amended exclusive license agreement with the University of Pittsburgh, consolidating multiple technologies for Type 1 and Type 2 diabetes gene therapy. The agreement covers worldwide exclusive rights to patent applications and technologies related to gene therapy using Pdx1 and MafA transcription factors.
The company has also formed Convergen Biotech, a wholly-owned subsidiary focused on diabetes program development. Their gene therapy product, GPX-002, is designed to transform pancreatic alpha cells into functional beta-like cells for T1D treatment and rejuvenate exhausted beta cells for T2D treatment. The therapy is administered via routine endoscopy into the pancreatic duct.
Genprex plans to seek FDA guidance for preclinical studies needed for IND application by the second half of 2025. The separation of the diabetes program into Convergen Biotech aims to expedite clinical development and enable potential direct investment and strategic collaboration.
Genprex (NASDAQ: GNPX) announced new research findings showing that NPRL2 gene therapy, using their Oncoprex® Delivery System, demonstrates significant potential in treating anti-PD1 resistant non-small cell lung cancer (NSCLC). The study, published in eLife, revealed that NPRL2 treatment alone showed dramatic antitumor effects in KRAS/STK11 double mutant NSCLC xenografts, while pembrolizumab (Keytruda®) alone was ineffective.
The research utilized Genprex's non-viral ONCOPREX Delivery System, which uses lipid nanoparticles to deliver tumor suppressor genes intravenously. The study demonstrated stronger antitumor effects in humanized mice compared to non-humanized NSG mice, indicating that NPRL2's effectiveness works through immune system activation. This breakthrough could potentially target approximately 30% of NSCLCs with KRAS mutations.
Genprex (NASDAQ: GNPX) has announced the dosing of the first patient in the Phase 2 expansion portion of its Acclaim-3 clinical study, evaluating Reqorsa® Gene Therapy combined with Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC).
The Phase 2 expansion will enroll 50 patients across 10-15 U.S. sites, with an interim analysis planned after the first 25 patients reach 18 weeks of follow-up, expected in the second half of 2025. The study's primary endpoint is to determine the 18-week progression-free survival rate.
Current ES-SCLC patients have a median progression-free survival of 5.2 months, with those receiving Tecentriq maintenance therapy showing 2.6 months. The treatment combination has received both FDA Fast Track and Orphan Drug Designations. Preclinical data from October 2023 showed the combination therapy provided better tumor control than either agent alone.
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco. The company's executive team, including Ryan Confer (President, CEO, and CFO), Dr. Mark Berger (Chief Medical Officer), and Thomas Gallagher (SVP of Intellectual Property and Licensing), will attend the conference.
The executives will be available for one-on-one meetings with industry and investor groups to discuss Genprex's gene therapies for cancer and diabetes. Interested parties can schedule meetings through Investor Relations at investors@genprex.com.
Genprex (NASDAQ: GNPX) has completed the Phase 1 dose escalation portion of its Acclaim-3 clinical trial, testing Reqorsa® Gene Therapy with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC). The Safety Review Committee approved advancing to Phase 2 after finding no dose limiting toxicities, setting the Recommended Phase 2 Dose at 0.12 mg/kg.
The first patient showed a partial remission with a 30% tumor decrease after two cycles, though progression was noted after four cycles. The Phase 2 expansion will enroll approximately 50 patients across 10-15 U.S. sites, focusing on 18-week progression-free survival rates. The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation for SCLC treatment.
Genprex (NASDAQ: GNPX) has secured a worldwide exclusive license from the University of Michigan for patent rights relating to Reqorsa® Gene Therapy in combination with ALK-inhibitors for treating ALK-EML4 positive lung cancer. Preclinical data showed that Reqorsa induced apoptosis in alectinib resistant EML4-ALK positive non-small cell lung cancer cells. The research indicates that TUSC2, a tumor suppressor gene frequently deleted in lung cancer, when overexpressed in ALK+ NSCLC cell lines, effectively decreased cell growth through activation of apoptotic pathways.
Genprex announced positive preclinical data for its lead drug candidate Reqorsa® Gene Therapy at the Society for Immunotherapy of Cancer Meeting. Research collaborators at Meharry Medical College demonstrated that Reqorsa effectively modulates immune responses against cancers. The study showed that in TUSC2 Knock Out mice treated with Reqorsa, tumor growth was diminished, with significant reduction in T reg cells and increase in Cytotoxic T cells and NK cells within tumor infiltrating leucocytes. The research validates Reqorsa's anti-tumor mechanisms and its potential to treat various cancers, particularly in individuals with low TUSC levels due to aging, chronic inflammation, or metabolic diseases.