On April 21, 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 the Company has entered into a new Sponsored Research Agreement (SRA) with The University of Texas MD Anderson Cancer Center (UT MD Anderson) to study biomarkers that may predict patient response to Reqorsa Gene Therapy (quaratusugene ozeplasmid), the Company’s lead drug candidate that is in development for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
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Shortly after it was founded, Genprex entered its first SRA with UT MD Anderson in 2010, and the two parties have completed several subsequent SRAs. These efforts demonstrate Genprex’s commitment to innovative cancer treatments and improving outcomes for patients through the continued research and development of its oncology pipeline.
In preclinical studies, research collaborators have identified TROP2 and PTEN as two potential biomarkers that may increase the likelihood of patient response to REQORSA. TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that functions as a cell surface receptor. TROP2 overexpression in adult tissues is a hallmark of many solid tumors, making it a major target for modern cancer therapies. PTEN (phosphatase and tensin homolog) is a tumor suppressor gene that serves as a multi-functional cancer biomarker for risk assessment, diagnosis and treatment planning in a number of cancers.
"We are very excited to expand our research of TROP2 and PTEN to better understand how these biomarkers might predict and improve outcomes in patients treated with REQORSA," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe this research agreement demonstrates Genprex’s commitment to developing tailored treatment options for lung cancer patients who have unmet medical need, and we believe this research sets Genprex at the forefront of precision oncology treatment."
Research with TROP2 and PTEN may provide insights that could refine Genprex’s patient selection strategies for its Acclaim-1 and Acclaim-3 clinical trials and optimize clinical outcomes.
Acclaim-1 is a Phase 1/2 clinical trial that uses a combination of REQORSA and AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (EGFR) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Genprex is currently enrolling and treating patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study. The Phase 1 portion showed REQORSA was generally well tolerated with no dose limiting toxicities (DLTs) despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (PFS). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 60 courses of treatment (approximately 42 months), and this patient continues to receive REQORSA and Tagrisso treatment to date.
Acclaim-3 is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex is currently enrolling and treating patients in the Phase 2 expansion portion of the Acclaim-3 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study, which showed no DLTs. One patient in the Phase 1 portion of the study achieved an unconfirmed partial remission after 24 cycles of therapy and continues to receive study treatment in the trial after more than 18 months.
"We have seen in our Acclaim clinical trials that there are some patients whose cancer progresses after a short number of cycles of treatment, but we have also seen that some patients benefit from REQORSA for a very long time, in one case for more than three years," said Mark Berger, Chief Medical Officer at Genprex. "It is important to understand why some patients are responding very well to REQORSA, and we believe that the identification of biomarkers will allow us to predict which future patients may have these similar, positive responses. This meaningful research will not only benefit patients, but we believe it will allow for better prediction of those likely to benefit in the future."
(Press release, Genprex, APR 21, 2026, View Source [SID1234664610])