Genprex Announces Collaboration with Roche Diagnostics for Biomarker Assay Validation Studies
Rhea-AI Summary
Genprex (NASDAQ: GNPX) announced a collaboration with Roche Diagnostics to validate biomarker assays for patient selection in non-small cell lung cancer (NSCLC) clinical trials. The work focuses on using TROP2 as a biomarker, informed by Genprex data linking high TROP2 and low PTEN H-scores to improved Progression Free Survival (PFS) in NSCLC patients.
According to Genprex, Roche Diagnostics, which received FDA Breakthrough Device Designation for an AI-driven TROP2 companion diagnostic, will perform assay validation using its established TROP2 antibody. Genprex plans to complete validation studies by approximately the end of 2026 and then seek to integrate TROP2-based patient selection into its NSCLC clinical program, depending on validation results. The collaboration is intended to support more precise enrollment in studies of Genprex’s lead product candidate, Reqorsa Gene Therapy, and advance biomarker-driven precision medicine in oncology.
Positive
- Biomarker collaboration with Roche Diagnostics to validate TROP2 assay for NSCLC patient selection
- Existing data link high TROP2 and low PTEN H-scores to longer PFS in NSCLC patients
- Use of Roche’s FDA Breakthrough Device–associated TROP2 antibody for Genprex validation studies
- Target timeline to complete TROP2 assay validation by approximately end of 2026
- Potential integration of TROP2-based patient selection into NSCLC clinical program after validation
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 22 | Canadian patent notice | Positive | -7.1% | Canadian patent allowance expanded protection for Reqorsa combinations in lung cancer. |
| Jun 17 | Conference participation | Neutral | +10.9% | Genprex scheduled investor meetings at the BIO 2026 International Convention. |
| May 26 | Biomarker clinical data | Positive | -6.0% | Biomarker findings associated TROP2 and PTEN scores with longer progression-free survival. |
| May 14 | Preclinical diabetes data | Positive | +1.2% | GPX-002 improved beta-cell function and insulin secretion in diabetic mouse models. |
| Apr 30 | Israeli patent grant | Positive | +12.1% | Israel granted patent protection for Reqorsa combined with PD-1 antibodies. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Genprex's recent news reactions were mixed, with positive developments followed by both gains and declines.
Key Terms
trop2 medical
pten medical
progression free survival medical
companion diagnostic medical
breakthrough device designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Collaboration Advances Biomarker-Driven Patient Selection and Precision Medicine in Oncology
Validation Studies Aim to Optimize Clinical Trial Patient Selection Criteria
Genprex's initial research demonstrated that high TROP2 H-scores and low PTEN H-scores predicted patient response in preclinical studies. These findings were further correlated with longer Progression Free Survival (PFS) in clinical studies, specifically for NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100. This data underscores the potential of these biomarkers to enable targeted patient selection and precision medicine. Additional data have shown that intensity of TROP2 expression may have a correlation with PFS.
"This strategic partnership with Roche Diagnostics, a recognized leader in NSCLC assay development and the recipient of an FDA Breakthrough Device Designation for their AI-driven TROP2 diagnostic, is a testament to our shared commitment to advancing precision treatments in oncology," said Ryan Confer, President and Chief Executive Officer at Genprex. "By utilizing the same validated TROP2 antibody that Roche has used in other studies, we are poised to shorten the time for patient identification and recruitment for NSCLC clinical trials, ultimately delivering more effective, personalized treatment options."
The collaboration leverages Roche Diagnostics' expertise in assay development. Roche Diagnostics received
Genprex is expanding on its preclinical and clinical studies to potentially integrate TROP2 expression for patient selection in NSCLC clinical studies. Roche Diagnostics will perform the necessary assay validation using its TROP2 antibody. Genprex anticipates completing these validation studies by approximately the end of 2026, with subsequent integration into its NSCLC clinical program shortly thereafter, dependent on the results of the validation studies. This collaboration exemplifies Genprex's commitment to delivering innovation that enables more precise diagnosis and treatment strategies in oncology, ultimately aiming to improve outcomes for NSCLC patients.
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 MD Anderson 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, 2025.
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: Genprex's collaboration with Roche Diagnostics, the intended goals and potential benefits of the collaboration, and expectations for the collaboration's advancement of biomarker-driven patient selection and precision medicine in oncology, including intentions to refine patient identification using TROP2 as a biomarker and the aims of validation studies to optimize clinical trial patient selection criteria; 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, its intended regulatory submissions and any resulting regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to regain and 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; Genprex's intellectual property and licenses; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates.
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.
(877) 774-GNPX (4679)
GNPX Investor Relations
investors@genprex.com
GNPX Media Contact
Kalyn Dabbs
media@genprex.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/genprex-announces-collaboration-with-roche-diagnostics-for-biomarker-assay-validation-studies-302840287.html
SOURCE Genprex, Inc.