On August 3, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported its collaboration with Roche Diagnostics to validate biomarkers for patient selection in clinical trials for non-small cell lung cancer (NSCLC). Building on promising preclinical and clinical data, this collaboration intends to refine patient identification using TROP2 as a biomarker.
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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 U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for the first AI-driven companion diagnostic for NSCLC that uses a TROP2 score to evaluate NSCLC specimens, and Genprex will use the same antibody against TROP2 for its validation studies. This strategic alignment ensures consistency and builds upon established diagnostic methods.
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.
(Press release, Genprex, AUG 3, 2026, View Source [SID1234669606])