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Genprex, Inc. (NASDAQ: GNPX) is a pioneering clinical-stage gene therapy company committed to transforming the landscape of cancer and diabetes treatments. The company's mission is to address the unmet medical needs of a growing population of patients worldwide through the development of innovative immunogene therapies. Genprex's flagship product, Reqorsa Immunogene Therapy (quaratusugene ozeplasmid), is at the forefront of its oncology program and is currently being evaluated in three clinical trials targeting non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
Oncoprex® Delivery System, Genprex's proprietary platform, encapsulates gene-expressing plasmids using lipid-based nanoparticles. This systemic, non-viral method enables the intravenous delivery of tumor suppressor genes to cancer cells, which then express proteins that were deficient in the tumor. Reqorsa Immunogene Therapy has shown promise by re-establishing pathways for programmed cell death, interrupting cancer cell signaling, and modulating immune responses.
The company's recent achievements include securing new patents and receiving FDA Fast Track and Orphan Drug designations for its clinical programs. Specifically, the Acclaim-2 and Acclaim-3 studies are exploring the potential of Reqorsa in combination with immune checkpoint inhibitors like Keytruda® and Tecentriq®. These trials aim to provide new therapeutic options for patients with advanced-stage lung cancers who have limited treatment alternatives.
In addition to its oncology initiatives, Genprex is advancing a novel gene therapy approach for diabetes. Using an AAV vector, the company delivers Pdx1 and MafA genes directly to the pancreas to transform alpha cells into beta-like cells capable of producing insulin. This method shows promise for both Type 1 and Type 2 diabetes and aims to offer a new lifeline for patients with these conditions.
Genprex collaborates with renowned institutions and industry leaders to further its research and development pipeline. The company's commitment to innovation and patient-centric solutions positions it as a significant player in the gene therapy landscape.
Latest News:
- March 12, 2024 - Genprex announces new patent grants in South Korea for Reqorsa® Immunogene Therapy.
- March 19, 2024 - Genprex enters into agreements for the sale and issuance of shares, expecting gross proceeds of $6.5 million.
- April 2, 2024 - Positive preclinical data for NPRL2 gene therapy presented at AACR Annual Meeting.
- April 3, 2024 - Multiple new trial sites added for Acclaim-3 study in extensive-stage small cell lung cancer.
- April 9, 2024 - Research collaborators present positive preclinical data supporting Reqorsa and NPRL2 therapies.
- May 8, 2024 - Genprex announces the passing of its co-founder and CEO Rodney Varner.
- May 14, 2024 - First patient dosed in Phase 1 of Acclaim-3 clinical study for Reqorsa® and Tecentriq® combination therapy.
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.
Genprex (NASDAQ: GNPX) announced its participation in the 2024 BIO Europe Conference, scheduled for Nov. 4-6, 2024 in Stockholm, Sweden, with virtual sessions on Nov. 12-13, 2024. Senior VP of Intellectual Property and Licensing Thomas Gallagher will attend in person, while CEO Ryan Confer and CMO Mark Berger will participate virtually.
The clinical-stage gene therapy company, focused on developing therapies for cancer and diabetes, will conduct one-on-one meetings with industry and investor groups during the conference. Interested parties can request meetings through the conference portal or contact Investor Relations directly.
Genprex announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, presented at the 2024 EORTC-NCI-AACR Symposium. The research showed promising results in treating Ras inhibitor resistant lung cancer, mesothelioma, and glioblastoma. The company filed two provisional patent applications based on the data for treating mesothelioma and glioblastoma. The presentations, delivered by research collaborators from prestigious institutions including MD Anderson Cancer Center, NYU Langone Health, and UT Health Science Center, focused on TUSC2 gene therapy's potential in treating these challenging cancers.
Genprex (NASDAQ: GNPX) has entered into a Sponsored Research Agreement with the University of Michigan Rogel Cancer Center to study TUSC2 combined with ALK-inhibitors in ALK-EML4 positive lung cancer. The company also announced a collaboration with ALK Positive, a non-profit patient research organization. Preclinical data presented at AACR 2024 showed REQORSA induced apoptosis in alectinib resistant EML4-ALK positive NSCLC cell lines. The research targets ALK+ lung cancer, found in approximately 5% of NSCLCs, where about 82% have decreased TUSC2 tumor suppressor protein. While current ALK-targeted therapies show initial benefits, resistance develops over time, with a 5-year survival rate of 40.9%.
Genprex (NASDAQ: GNPX) has announced progress in its Acclaim-3 clinical trial for Reqorsa® Gene Therapy combined with Tecentriq® in extensive stage small cell lung cancer (ES-SCLC). The company has completed the 0.09 mg/kg dose group and received approval to advance to the highest dose group of 0.12 mg/kg. Key points include:
- No dose limiting toxicities observed
- A partial remission noted in the first patient treated
- The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation
- Phase 1 dose escalation is expected to complete in the second half of 2024
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites
Preclinical data showed the combination therapy provided better tumor control than either agent alone in SCLC mouse models.
Genprex announced that its research collaborators will present positive preclinical data on Reqorsa® Gene Therapy at the 2024 EORTC-NCI-AACR Symposium. The presentations will cover Reqorsa's potential in treating Ras inhibitor resistant lung cancer, mesothelioma, and glioblastoma. Key findings include:
1. Reqorsa overcomes acquired resistance to Lumakras® in KRASG12C mutant NSCLC.
2. Reqorsa demonstrates potent tumor suppressive activity in mesothelioma cells.
3. Reqorsa induces apoptosis and shows promising efficacy in glioblastoma cells.
Genprex has filed two provisional patent applications based on the mesothelioma and glioblastoma data. The company views these results as validation of Reqorsa's potential in treating difficult cancers and possible expansion of its clinical development pipeline.
Genprex announced that its research collaborators at Meharry Medical College will present positive preclinical data on Reqorsa® Gene Therapy at the 39th Annual Society for Immunotherapy of Cancer Meeting in Houston, Texas, from November 6-10, 2024. The poster presentation will focus on Reqorsa's ability to modulate in vivo immune responses against cancers.
The study evaluates TUSC2's role in modulating immune responses in cancer. TUSC2 is the tumor suppressor gene used in REQORSA, which consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing uptake by normal tissue.
Ryan Confer, President and CEO of Genprex, expressed enthusiasm about the growing preclinical evidence supporting REQORSA's potential in treating various cancers and the opportunity to present these findings at the prestigious cancer meeting.
Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, has been featured in CEO/CFO Magazine. The article highlights the company's innovative gene therapies for cancer and diabetes. Ryan Confer, Genprex's President, CEO, and CFO, discussed:
- The company's gene therapy approaches in oncology and diabetes
- Recent updates to the Acclaim clinical trials in lung cancer
- New use of biomarker testing for the oncology program
- The popularity of GLP-1 agonists in diabetes treatment
- Potential partnerships and collaborations in gene therapy
- Plans to spin out the diabetes program into a wholly-owned subsidiary
Confer emphasized the importance of finding the right funding, partners, and collaborators to accelerate bringing innovative drugs to patients and creating value for stakeholders.
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