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Genprex Announces New Research Identifying TROP2 as a Potential Predictive Biomarker to Reqorsa® Gene Therapy in Lung Cancer

Genprex sees potential for TROP2 to guide patient selection if the findings are confirmed in further studies.

(Moderate)

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Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

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Genprex (GNPX) announced research identifying TROP2 expression as a potential marker of response to its REQORSA gene therapy in lung cancer. Low TROP2 expression was associated with resistance across preclinical models of non-small cell lung cancer; analysis of pretreatment patient tumor biopsies supported the association with treatment response.

Approximately 50% of 10 cell lines and 50% of 12 patient-derived organoid models showed primary resistance to TUSC2 gene delivery. Experimentally changing TROP2 expression altered cancer cell death induced by TUSC2, suggesting a possible role in treatment sensitivity. Further research and prospective clinical evaluation are required to establish TROP2's ability to predict patient response. The research will be presented on November 18, 2026, at the EORTC-NCI-AACR Symposium in Barcelona.

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Positive

  • Minor pointLow TROP2 expression was consistently associated with REQORSA resistance across multiple preclinical lung cancer models.
  • Minor pointPretreatment patient tumor biopsies supported the association between TROP2 expression and treatment response.
  • Minor pointExperimental TROP2 modulation altered TUSC2-induced cancer cell death, suggesting a role in treatment sensitivity.

Negative

  • Minor pointPrimary resistance occurred in approximately 50% of 10 cell lines and 50% of 12 patient-derived organoid models.
  • Minor pointTROP2's predictive utility requires additional research and prospective clinical evaluation in patients receiving REQORSA.

Key Figures

Cell lines with primary resistance: Approximately 50% of 10 NSCLC cell lines Organoid models with primary resistance: 50% of 12 patient-derived organoid models
Cell lines with primary resistance
Approximately 50% of 10 NSCLC cell lines
Preclinical models evaluated for TUSC2 gene delivery
Organoid models with primary resistance
50% of 12 patient-derived organoid models
Preclinical models evaluated for TUSC2 gene delivery

Historical Context

1 past event · Latest: Aug 03
1 event
  1. Aug 03

    Biomarker collaboration

    24h Move
    -20.7%

    Roche Diagnostics collaboration to validate TROP2 assays for NSCLC patient selection.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

trop2, nsclc, apoptosis, mapk, +2 more
6 terms
trop2 medical
"new research identifying TROP2 expression as a potential predictive biomarker"
Trop2 is a protein found on the surface of many cancer cells that acts like a visible flag doctors and drugmakers can use to find and attack tumors. It matters to investors because drugs designed to bind Trop2 can deliver treatment directly to cancer cells, affecting how well a therapy works, which patients it helps, and the potential market and regulatory value of companies developing those targeted treatments.
nsclc medical
"multiple preclinical models of non-small cell lung cancer (NSCLC)"
NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.
apoptosis medical
"inducing cell-cycle arrest and apoptosis"
Apoptosis is a controlled, built‑in process where cells deliberately shut down and are safely removed, like a person retiring and clearing out their belongings so the house stays orderly. Investors care because many drugs and diagnostics target or measure this process: how well a therapy triggers or avoids apoptosis can determine clinical trial success, safety profiles, regulatory approval, and ultimately a company’s valuation.
mapk medical
"inhibiting MAPK and mTOR signaling"
MAPK (Mitogen‑Activated Protein Kinase) is a family of enzymes in cells that act like switches or traffic signals, passing along messages that tell cells to grow, divide, or respond to stress. It matters to investors because abnormal MAPK signaling is implicated in cancers and other diseases, making these enzymes common targets for drugs and diagnostics; progress or setbacks in MAPK‑related research can materially affect the value of biotech and pharmaceutical companies.
mtor medical
"inhibiting MAPK and mTOR signaling"
mTOR is a key protein in cells that acts like a central control switch, coordinating growth, fuel use and repair in response to nutrients and hormones. Investors watch mTOR because drugs that block or tweak its activity are used to treat cancers, metabolic and immune diseases; progress or setbacks in related clinical trials can strongly affect a company’s drug prospects and stock value.
lipoplex technical
"in a lipoplex form"
A lipoplex is a microscopic complex formed when positively charged (cationic) lipids bind electrostatically to negatively charged nucleic acids (DNA, RNA or oligonucleotides) to create a particle that protects the genetic material and helps deliver it into cells. Lipoplexes behave like lipid-based delivery vehicles: they condense and shield the nucleic acid, are taken up by cells (typically via endocytosis), and can release cargo after disrupting endosomal membranes; they are distinct from more structured lipid nanoparticles (LNPs) in composition and preparation, often relying on simple charge-driven assembly rather than multi-component nanoparticle formulations.

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Research to be Presented at the 2026 EORTC-NCI-AACR Symposium Links TROP2 Expression to Treatment Response and Explores its Role in Treatment Sensitivity

Findings Suggest Low TROP2 Expression is Associated with Primary Resistance to REQORSA and May Help Guide Patient Selection

AUSTIN, Texas, Nov. 4, 2026 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage biotechnology company developing gene therapies designed to restore tumor-suppressor function in cancer and insulin-producing function in diabetes, today announced new research identifying TROP2 expression as a potential predictive biomarker of response to its lead drug candidate, Reqorsa® (quaratusugene ozeplasmid), a gene therapy product, will be presented at the 2026 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-20, 2026 in Barcelona, Spain.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. (PRNewsfoto/Genprex, Inc.)

The research collaborators found that low TROP2 expression was consistently associated with resistance to REQORSA across multiple preclinical models of non-small cell lung cancer (NSCLC). This finding was also supported by analysis of pretreatment tumor biopsies from patients enrolled in a clinical trial evaluating REQORSA.

"Discovering an applicable biomarker of response is a meaningful step toward a more precise approach to treating lung cancer with REQORSA," said Ryan Confer, President and Chief Executive Officer of Genprex. "These data show that low TROP2 expression was associated with primary resistance across multiple preclinical models, and this was supported by analysis of patient biopsies from a clinical trial. If confirmed in further studies, TROP2 could not only help us enhance our clinical trials by recruiting and selecting more applicable patients, but, more importantly, benefit future patients by ultimately delivering potentially more effective, personalized treatment options. This work reflects our commitment to a precision-medicine approach to treating lung cancer."

The TUSC2 tumor suppressor protein expression is downregulated or absent in more than 80% of NSCLC cases and nearly all small cell lung cancers. Previous studies have shown that REQORSA has antitumor activity, including in models resistant to targeted therapies and in immunotherapy-resistant KRAS/LKB1-mutant NSCLC. REQORSA's effects are mediated by inhibiting MAPK and mTOR signaling, inducing cell-cycle arrest and apoptosis, and activating antitumor immune responses.

Key findings from the research include:

  • TROP2 expression associated with resistance: Approximately 50% of 10 NSCLC cell lines and 50% of 12 patient derived organoid models evaluated showed primary resistance to TUSC2 gene delivery. Protein-expression analyses consistently identified low TROP2 expression as a marker associated with resistance across multiple preclinical models.
  • Supporting clinical evidence: Analysis of pretreatment tumor biopsies from patients enrolled in a TUSC2 gene therapy clinical trial supported the association between TROP2 expression and treatment response.
  • TROP2 modulation influenced treatment sensitivity: Experimental manipulation of TROP2 expression altered TUSC2-induced cancer cell death, suggesting that TROP2-dependent signaling may play a role in therapeutic response. Further research is underway to understand these context-dependent effects.

Collectively, the findings identify TROP2 as a potential predictive biomarker for response to REQORSA and suggest that modulating TROP2 signaling may be a novel strategy to enhance the therapeutic efficacy of REQORSA in NSCLC. While these findings provide preclinical and supportive clinical evidence, additional research and prospective clinical evaluation will be required to establish TROP2's predictive utility in patients receiving REQORSA.

The featured Genprex-supported poster is to be presented at the 2026 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics:

Title: TROP2 Predicts Response to TUSC2 Gene Therapy (Quaratusugene Ozeplasmid) and Its Modulation Sensitizes Non-Small Cell Lung Cancer to Treatment
Conference: 2026 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
Topic: Drug Resistance and Modifiers
Session Date and Time: Wednesday, Nov. 18, 2026
Time: 12:00–6:00 p.m. CET
Abstract Number: 108
Poster Board Number: PB-108
Location: CCIB, Barcelona, Spain

The EORTC-NCI-AACR 2026 poster is expected to be available on Genprex's website following the presentation, subject to applicable conference disclosure requirements.

About Reqorsa® Gene Therapy
Reqorsa® (quaratusugene ozeplasmid), a gene therapy product, 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 focusing on developing innovative treatments designed to restore biological functions disrupted by disease. The Company's lead oncology program, Reqorsa® (quaratusugene ozeplasmid), a gene therapy product, is being developed for the treatment of lung cancer and is designed to deliver the TUSC2 tumor suppressor gene to help restore tumor-suppressive activity and address multiple pathways involved in cancer progression.

The Company's lead candidate, REQORSA, uses the systemic, non-viral ONCOPREX® Delivery System to deliver the TUSC2 tumor suppressor gene via a non-viral lipid-based nanoparticle. REQORSA is designed to restore tumor-suppressor function and is being evaluated in the Acclaim-1 and Acclaim-3 clinical trials for non-small cell lung cancer and small cell lung cancer, respectively. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to both lung cancer programs and Orphan Drug designation to the small cell lung cancer program.

Genprex is also advancing an earlier stage gene therapy program for diabetes, designed to restore insulin-producing capability through the expression of key pancreatic transcription factors. Across its programs, Genprex is focused on translating innovative gene therapy approaches into meaningful therapeutic advances for patients with significant unmet medical needs.

For more information, please visit https://www.genprex.com/, register for our Email Alerts and follow us on LinkedIn, X, and Facebook.

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 ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications, including identifying TROP2 expression as a potential predictive biomarker of response to REQORSA in NSCLC which has the potential of delivering more effective, personalized treatment options; 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 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 Contact
Lisa DeScenza
ldescenza@lavoiegroup.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

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SOURCE Genprex, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Genprex's TROP2 research find about REQORSA response?

Low TROP2 expression was associated with resistance to REQORSA across multiple preclinical models of non-small cell lung cancer. Analysis of pretreatment tumor biopsies from patients in a TUSC2 gene therapy trial supported the association between TROP2 expression and treatment response.

Is TROP2 established as a predictive biomarker for Genprex's REQORSA?

TROP2 remains a potential predictive biomarker, not an established predictor of patient response to REQORSA. Additional research and prospective clinical evaluation are required to establish its predictive utility.

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