Clinical-stage gene therapy company Genprex has entered into a strategic collaboration with Roche Diagnostics to validate biomarkers that could improve patient selection in clinical trials for Non-Small Cell Lung Cancer (NSCLC). The partnership aims to support precision oncology by validating TROP2 as a key biomarker for identifying patients most likely to benefit from Genprex's investigational gene therapy.

The collaboration builds on encouraging preclinical and clinical findings that linked high TROP2 expression and low PTEN expression with improved treatment outcomes. According to Genprex, NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100 demonstrated longer Progression-Free Survival (PFS), suggesting these biomarkers could play an important role in guiding personalised treatment strategies. Additional studies have also indicated that the intensity of TROP2 expression may correlate with improved clinical outcomes.

Under the agreement, Roche Diagnostics will conduct assay validation using the same TROP2 antibody employed in its diagnostic development programmes. Roche previously received US Food and Drug Administration (FDA) Breakthrough Device Designation for its artificial intelligence-driven companion diagnostic designed to assess TROP2 expression in NSCLC specimens, providing a validated foundation for the collaboration.

Ryan Confer, President and Chief Executive Officer of Genprex, said the partnership reflects a shared commitment to advancing precision oncology. He noted that leveraging Roche's validated TROP2 assay is expected to streamline patient identification and recruitment for NSCLC clinical trials, helping accelerate the development of more personalised treatment options.

Genprex plans to expand its ongoing research by incorporating validated TROP2 expression as a patient selection tool in future NSCLC clinical studies. The company expects assay validation to be completed by the end of 2026, after which the biomarker could be integrated into its clinical development programme, subject to successful validation results.

The collaboration also supports the clinical advancement of Reqorsa (quaratusugene ozeplasmid), Genprex's investigational gene therapy candidate. Reqorsa is designed to deliver the tumour suppressor TUSC2 gene directly to cancer cells using non-viral lipid nanoparticles while limiting uptake by healthy tissue. Laboratory studies conducted at MD Anderson Cancer Center have shown tumour cells absorbed the therapeutic gene at levels 10 to 33 times higher than normal cells, highlighting the therapy's targeted delivery approach.

By combining Genprex's gene therapy platform with Roche Diagnostics' expertise in biomarker assay development, the companies aim to advance more precise patient selection strategies and improve clinical outcomes for patients with advanced non-small cell lung cancer.