Genprex Signs Exclusive License to Additional Gene Therapy Technology with UTHealth Houston for the Treatment of Glioblastoma
- Exclusive commercial rights and patent exclusivity secured for REQORSA in glioblastoma treatment
- Positive preclinical data showing significant reduction in glioblastoma cell viability
- Expansion into new indication (glioblastoma) beyond existing lung cancer applications
- Addresses unmet medical needs in treating the deadliest primary brain tumor
- Still in early preclinical stage, requiring further testing in mouse models
- No human trial data available yet for glioblastoma indication
- Significant time and resources needed for clinical development and potential approval
Insights
Genprex expands potential market with exclusive glioblastoma license, but remains in early preclinical stage with long development path ahead.
This exclusive license agreement with UTHealth Houston represents a strategic expansion of Genprex's intellectual property portfolio beyond its initial focus on lung cancer. By securing commercial rights for Reqorsa in glioblastoma treatment, the company diversifies its potential therapeutic applications into a high-need neurological indication.
The preclinical data mentioned shows promising in vitro results, with Reqorsa demonstrating the ability to reduce glioblastoma cell viability and suppress cell migration. However, these findings represent very early-stage research, with researchers still recommending further evaluation in animal models before potential clinical investigation.
From a commercial perspective, this agreement strategically positions Genprex in the glioblastoma space, described as "the most common and deadliest primary brain tumor in adults." The unmet medical need in glioblastoma is significant, as current treatment options are limited and outcomes generally poor.
Notably, the press release doesn't disclose any financial terms, making it difficult to assess immediate economic impact. Investors should recognize that while this expands Genprex's potential addressable market, development of central nervous system therapeutics presents unique challenges, including crossing the blood-brain barrier.
This licensing deal represents an initial step in what would typically be a multi-year development process before potential commercialization, with significant scientific and regulatory hurdles still to overcome before Reqorsa could reach glioblastoma patients.
Early-stage TUSC2 gene therapy shows promising lab results for glioblastoma but faces long development path before clinical relevance.
The scientific foundation of this approach centers on TUSC2 (tumor suppressor candidate 2), a gene with established tumor suppressive functions in lung cancer that UTHealth Houston researchers have now identified as relevant to glioblastoma biology. The license enables Genprex to explore this mechanism in brain cancer, potentially addressing critical therapeutic gaps.
The preclinical data revealed two significant findings: First, Reqorsa (quaratusugene ozeplasmid) successfully restored TUSC2 expression in patient-derived glioblastoma cell lines and reduced cell viability. Second, it suppressed glioblastoma cell migration independently of its viability effects, suggesting potential impact on tumor invasiveness—a hallmark challenge in glioblastoma treatment.
These laboratory findings provide mechanistic rationale but represent extremely preliminary evidence. The researchers appropriately acknowledge the need for further evaluation in animal models, which would assess crucial factors like delivery across the blood-brain barrier, tumor penetration, and safety profile.
Glioblastoma presents unique treatment challenges due to its heterogeneity, invasive nature, and protected location. Most therapeutic agents fail to effectively cross the blood-brain barrier, and those that do often face resistance mechanisms. While TUSC2 restoration represents a scientifically sound approach targeting fundamental cancer biology rather than surface markers, the path from promising in vitro data to effective human therapy remains extraordinarily challenging in this indication.
License Expands Genprex's Portfolio of Oncology Gene Therapy Technologies
"We are pleased to expand our portfolio of licensed patents and add a technology that uses REQORSA to treat glioblastoma," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. "With this license agreement, Genprex has obtained exclusive commercial rights to REQORSA in glioblastoma while also adding to our patent estate. The role of TUSC2 in lung cancer has been well established, and this latest license enables Genprex to expand the use of REQORSA into a new indication, in which the cancer can be difficult to treat and there are unmet medical needs."
REQORSA may be a potential therapeutic treatment for glioblastoma. Genprex previously reported positive preclinical data on the efficacy of REQORSA in glioblastoma in October 2024 at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Research collaborators from UTHealth Houston previously reported TUSC2 as a novel tumor suppressor for glioblastoma, the most common and deadliest primary brain tumor in adults which is associated with a poor prognosis. In their latest study, UTHealth Houston researchers used patient-derived glioblastoma (GBM) cell lines and patient-derived glioma stem cell (PD-GSC) lines. REQORSA was used to restore TUSC2 expression.
Researchers at UTHealth Houston observed that REQORSA significantly reduced GBM cell viability, and the results of a migration assay demonstrated that REQORSA suppressed GBM cell migration independent of its ability to suppress cell viability. In conclusion, REQORSA demonstrates promising in vitro efficacy in GBM and PD-GSCs, and these results support further evaluation of its in vivo anti-tumor efficacy in malignant gliomas using mouse models.
About Reqorsa® Gene Therapy
REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company's Oncoprex® Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at The University of Texas MD Anderson Cancer Center show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.
Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2024.
Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: REQORSA's potential as a therapeutic treatment for glioblastoma; Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals, the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.
These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.
Genprex, Inc.
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