Reqorsa (quaratusugene ozeplasmid) / Genprex - LARVOL DELTA

Acclaim-3: Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: Genprex, Inc. | Trial completion date: Aug 2027 ➔ Jun 2028 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TROP2 Predicts Response to TUSC2 Gene Therapy (Quaratusugene Ozeplasmid) and Its Modulation Sensitizes Non-Small Cell Lung Cancer to Treatment (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Gene therapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TUSC2

Genprex…announced that The Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance to Genprex for a patent covering the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with either PD-1 or PD-L1 antibodies for the treatment of both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) (PRNewswire) - "This patent will expand on the previously granted patents for REQORSA in combination with PD-1 and PD-L1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Chile, China, Singapore Europe, Korea, Australia and Israel."

Patent • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Acclaim-1: Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov) - P1/2 | N=158 | Recruiting | Sponsor: Genprex, Inc. | Trial completion date: Sep 2027 ➔ Dec 2027 | Trial primary completion date: Sep 2026 ➔ Dec 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Acclaim-1: Reqorsa (Quaratusugene Ozeplasmid) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: Genprex, Inc. | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Acclaim-1: Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov) - P1/2 | N=158 | Recruiting | Sponsor: Genprex, Inc. | N=92 ➔ 158 | Trial completion date: Dec 2025 ➔ Sep 2027 | Trial primary completion date: Dec 2024 ➔ Sep 2026

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Predictive biomarkers for PFS in patients receiving quaratusugene ozeplasmid. (ASCO 2026) - P1, P1/2 | "Six patients with NSCLC were enrolled in the Acclaim-1 trial in combination with osimertinib, and one was enrolled in the Acclaim-2 trial in combination with pembrolizumab. Eleven patients with SCLC were enrolled in the Acclaim-3 trial in combination with atezolizumab... Following up on preclinical cell line and organoid models indicating that Trop-2 and PTEN protein expression correlated with response, levels of Trop-2 and PTEN protein were evaluated in patients treated with quaratusugene ozeplasmid. Despite the small number of samples evaluated, both Trop-2 H-scores above 100 and PTEN H-scores below 100 correlated with longer PFS in patients with NSCLC, but not in patients with SCLC."

Biomarker • Clinical • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PTEN • TACSTD2 • TUSC2

Acclaim-3: Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: Genprex, Inc. | Trial primary completion date: Feb 2026 ➔ Jun 2026

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Genprex, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Positive Clinical Data on Biomarkers in Patients Receiving Reqorsa Gene Therapy Published at the 2026 ASCO Annual Meeting (PRNewswire) - "Six patients with NSCLC were enrolled in the Acclaim-1 trial in combination with osimertinib; One patient was enrolled in the Acclaim-2 trial in combination with pembrolizumab; Eleven patients with small cell lung cancer (SCLC) were enrolled in the Acclaim-3 trial in combination with atezolizumab; In patients with NSCLC, Trop-2 H-scores above 100 correlated with prolonged PFS (p=0.05), and PTEN H-scores below 100 correlated with prolonged PFS (p=0.03); In patients with SCLC, Trop-2 H-scores were universally low, and thus non-evaluable. PTEN H-scores in patients with SCLC did not correlate with prolonged PFS (p=0.53)...Following up on preclinical cell line and organoid models indicating that Trop-2 and PTEN protein expression correlated with response, levels of Trop-2 and PTEN protein were evaluated in patients treated with quaratusugene ozeplasmid."

Biomarker • Preclinical • Retrospective data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Genprex Receives Patent Grant from The Israel Patent Office for the Combination of Reqorsa Gene Therapy and PD-1 Antibodies to Treat Cancer (PRNewswire) - "This patent will expand on the previously granted patents for REQORSA in combination with PD-1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and Europe."

Patent • Lung Cancer

Title: 'Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies' (Genprex Press Release) - "In the sensitive model, tumors in the alectinib-treated group shrank by 60%. Notably, treatment with Quar Oze alone, and particularly Quar Oze combined with alectinib, resulted in 79% tumor shrinkage (p value 0.0135 versus control), demonstrating a 23% improved outcome compared to alectinib alone. This suggests that Quar Oze might serve as a valuable adjunct therapy, especially for patients who have advanced disease and/or experience resistance to TKIs."

Preclinical • Non Small Cell Lung Cancer

Genprex…announced that its research collaborators' abstract has been selected for publication at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - " The abstract details positive clinical data from studies of predictive biomarkers in patients receiving its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of lung cancer."

Biomarker • Clinical data • Non Small Cell Lung Cancer

Title: 'TROP2 and PTEN are biomarkers of primary resistance to TUSC2 gene therapy in non-small cell lung cancer (NSCLC)' (Genprex Press Release) - "A panel of 10 NSCLC cell lines screened for TUSC2 sensitivity showed resistance in 50% of the cell lines, as assessed by annexin V staining and colony formation assays. Researchers evaluated TUSC2 sensitivity in 12 NSCLC PDXOs using ATP-based viability assays in 3D culture following TUSC2 or empty vector transfection. While some PDXOs were highly responsive to TUSC2 within 72 hours post-transfection, 50% of PDXOs exhibited primary resistance. TC314AR (Acquired Resistance) PDX tumors and xenograft models (A549AR, H1299AR, H23AR) were developed, grown in NSG mice, and then treated with TUSC2 gene therapy. 20-30% of tumors in every model showed resistance, with no significant reduction in size compared to the control tumors after treatment."

Preclinical • Non Small Cell Lung Cancer

Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies (AACR 2026) - "Background: Non-Small Cell Lung Carcinoma (NSCLC) harboring the EML4-ALK fusion gene (Echinoderm Microtubule-Associated Protein-Like 4-Anaplastic Lymphoma Kinase) comprises about 5% of NSCLC cases. In the resistant model, the QO and alectinib combination produced a synergistic effect, achieving the greatest tumor reduction and improved overall survival (p value 0.0001 versus control), further supporting the clinical potential of this therapeutic strategy in ALK+ NSCLC. Altogether, our in vitro and in vivo studies indicate that QO-mediated TUSC2 overexpression in ALK+ NSCLC effectively curtails tumor growth and proliferation via activation of apoptotic pathways, providing a compelling rationale for progressing towards clinical trial."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • TUSC2

Restoring TUSC2 function boosts NK cell cytotoxicity and antitumor immunity in vivoand in vitro (AACR 2026) - "Building on our prior work identifying TUSC2 as a mitochondrial protein involved in calcium regulation and immune modulation, we hypothesized that TUSC2 exerts antitumor effects in part by enhancing NK cell cytotoxicity.Methods Tusc2 knockout (Tusc2 KO) and wild-type (Tusc2 WT) mice were challenged with syngeneic tumor cells (344SQ) and treated with TUSC2-expressing lipoparticles (quaratusugene ozeplasmid, Quar Oze)...Therapeutic delivery of TUSC2 via Quar Oze suppresses tumor progression and, in many cases, drives complete tumor elimination. These results highlight TUSC2 as a potent immunomodulatory tumor suppressor and support its development as a dual-function therapeutic that directly targets tumor cells while also activating NK cell-mediated immunity"

Preclinical • Breast Cancer • Head and Neck Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • GZMB • LAMP1 • PRF1 • TUSC2

Genprex, Inc. announced 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)…that is in development for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). (Genprex Press Release) - "Research on Biomarkers May Help Enrich Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials, Potentially Predicting Patient Response to REQORSA Treatment."

Commercial • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma can induce cellular apoptosis (AACR 2024) - "Furthermore, we have observed a robust pro-apoptotic response to TUSC2 expression in ALK+ NSCLC, as both quaratusugene ozeplasmid and TUSC2-containing plasmid induced an increase in caspase 3/7 activity in the cancer cells, accompanied by an increase in cleaved PARP expression. Taken together, our data indicate that overexpression of TUSC2 in ALK+ NSCLC cell lines with quaratusugene ozeplasmid or with TUSC2-containing plasmid is effective in decreasing growth and proliferation through the activation of apoptotic pathways and warrants further investigation as an anti-ALK NSCLC strategy."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CASP3 • CASP7 • EML4 • TUSC2

TUSC2 suppresses energy metabolism in lung cancer cells with opposite effects in normal bronchial epithelial cells (AACR 2024) - "TUSC2 resides in mitochondria and is involved mitochondrial respiration/energy metabolism, ROS production, Ca2+ flux to/from mitochondria, etc. Studies on tumor-bearing mice treated with TUSC2-containing plasmid encapsulated in lipid nanoparticles (quaratusugene ozeplasmid) and Phase I and II clinical trials of quar oze in lung cancer patients provides a strong rationale to further study the tumor-protective mechanisms of TUSC2 protein... All three cell lines demonstrated high transfection efficiency. Seahorse analysis revealed that TUSC2 re-introduction to TUSC2-deficient cancer cells consistently suppressed both glycolytic and mitochondrial ATP production, thus leaving cells without sufficient energy to support their vital functions. We found a significant decrease in basal and maximal respiration, spare respiratory capacity, ATP production, glycolysis and glycolytic capacity in cancer cell lines transfected with TUSC2-expressing plasmid."

Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Mesothelioma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • TUSC2

Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy (AACR 2025) - "The resistant cell lines also showed resistance to adagrasib, another KRASG12C inhibitor...The H23AR tumors, which exhibited no significant sensitivity to sotorasib, showed robust antitumor effects of quaratusugene ozeplasmid, a lipoplex gene therapy containing the TUSC2 gene in both H23AR and TC314AR PDXs...This antitumor effect was correlated with significant infiltration of human CD8 T, NK, DC, and M1 MQ, and downregulation of MDSCs and exhausted T cells. TUSC2 therapy, alone or in combination with sotorasib, induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C AR tumors"

Gene therapy • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ANXA5 • CD34 • CD8 • KRAS • TUSC2

Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies (PRNewswire) - "The findings show that Quar Oze-driven TUSC2 overexpression initiates a robust pro-apoptotic response in ALK-positive (ALK+) models, not only in cells that are sensitive but also with acquired resistance (generated in the lab) to the ALK inhibitor, alectinib. This is evidenced by increased pro-apoptotic markers and lower cell viability when Quar Oze is used in combination with alectinib....In the sensitive model, tumors in the alectinib-treated group shrank by 60%. Notably, treatment with Quar Oze alone, and particularly Quar Oze combined with alectinib, resulted in 79% tumor shrinkage (p value 0.0135 versus control), demonstrating a 23% improved outcome compared to alectinib alone."

Preclinical • Non Small Cell Lung Cancer

Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa Gene Therapy for the Treatment of Lung Cancer at the 2026 AACR Annual Meeting (PRNewswire) - "A panel of 10 NSCLC cell lines screened for TUSC2 sensitivity showed resistance in 50% of the cell lines, as assessed by annexin V staining and colony formation assays....TC314AR (Acquired Resistance) PDX tumors and xenograft models (A549AR, H1299AR, H23AR) were developed, grown in NSG mice, and then treated with TUSC2 gene therapy. 20-30% of tumors in every model showed resistance, with no significant reduction in size compared to the control tumors after treatment. Protein expression profiling using reverse-phase protein array (RPPA) analysis of 500 proteins showed distinct expression signatures, with several candidate biomarkers significantly altered in resistant cell lines and PDXOs."

Preclinical • Non Small Cell Lung Cancer

Restoring TUSC2 function boosts NK cell cytotoxicity and antitumor immunity in vivo and in vitro (PRNewswire) - "In vitro studies evaluated NK cell cytotoxic function following Quar Oze treatment by measuring CD107a degranulation and CellTrace Violet–based proliferation. In the therapeutic treatment group, 67% of Tusc2 KO mice and 33% of Tusc2 WT mice achieved complete tumor regression, with all remaining mice showing significant tumor reduction compared with controls. Prophylactic administration did not induce complete tumor clearance but consistently reduced tumor growth across all mice. Immune profiling of the tumor microenvironment revealed that Quar Oze robustly enhanced NK cell cytotoxicity, particularly increasing granzyme B and perforin expression."

Preclinical • Non Small Cell Lung Cancer

Genprex Strengthens Intellectual Property Portfolio with Japanese and EU Patents for Reqorsa Gene Therapy in Combination with Immunotherapies to Treat Cancer (Yahoo Finance) - "Japanese Patent Covers Acclaim-3 Clinical Trial Combining REQORSA Gene Therapy with Genentech, Inc.'s Tecentriq."

Patent • Small Cell Lung Cancer

Genprex Announces IP Australia's Intent to Grant Patent for Reqorsa Gene Therapy in Combination with PD-L1 Antibodies to Treat Cancers (PRNewswire) - "A granted patent will secure exclusivity for this drug combination in Australia, preventing potential competitors from manufacturing, using or selling it....In addition, the Company has also recently opened an additional clinical trial site for the Acclaim-3 clinical trial to include the University of Kentucky. The Company expects to add and open additional clinical trial sites for its Acclaim clinical trials in an effort to expand its reach to additional patients and expedite enrollment."

Patent • Trial status • Small Cell Lung Cancer