Annuncio • Mar 18

+ 1 more update

Genprex, Inc. to Present Positive Preclinical Data on Reqorsa Gene Therapy for Lung Cancer At the 2026 AACR Annual Meeting

Genprex, Inc. announced that its research collaborators will present at the upcoming 2026 American Association for Cancer Research (AACR) Annual Meeting being held April 17-22, 2026 in San Diego, California. The collaborators will present positive preclinical data from studies of its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid, also referred to as Quar Oze), for the treatment of lung cancer. The featured Genprex-supported posters to be presented at AACR 2026: Title: "TROP2 and PTEN are biomarkers of primary resistance to TUSC2 gene therapy in non-small cell lung cancer (NSCLC)" Session Category: Experimental and Molecular Therapeutics Session Title: Mechanisms of Drug Resistance 1. In this study, researchers established models primarily resistant to TUSC2 gene therapy (REQORSA or Quar Oze) to find biomarkers indicative of TUSC2 gene therapy resistance in NSCLC cell lines, PDX-derived organoids (PDXOs), and patient-derived xenografts (PDXs). 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. 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. RPPA analysis of residual tumors from both the xenograft and PDX models revealed significant but model-specific alterations in protein expression between responders and non-responders. Comparative analyses across the three models showed low expression of TROP2 and high expression of PTEN as potential biomarkers of primary resistance. Overexpression of TROP2 in H1299 and H460 cells increased TUSC2-induced apoptosis. These findings suggest that TROP2 and PTEN may serve as biomarkers to predict TUSC2 response and guide therapeutic strategies in NSCLC. Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies" Session Category: Experimental and Molecular Therapeutics Session Title: RNA, Gene and Cell Therapies, and Enabling Assay Technologies. In this study, researchers evaluated TUSC2 expression in a range of ALK+ cell lines and patient-derived organoids (PDOs), both prior to and following exposure to quaratusugene ozeplasmid (Quar Oze). 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. To further assess the Quar Oze and alectinib combination, researchers tested it in two in vivo models: (1) an alectinib-sensitive model using subcutaneous injection of NCI-H2228 ALK+ cells into nude mice, and (2) an alectinib-resistant model using ALK167 PDX implants in NSG mice. Once tumors reached ~ 100 mm³, mice were randomized into four groups: vehicle control; Quar Oze alone (25 µg/mouse, IV, every three days); alectinib alone (0.5 mg/kg for sensitive or 15 mg/kg for resistant, oral, daily); and Quar Oze plus alectinib at the same doses. 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. In the resistant model, the Quar Oze 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, the in vitro and in vivo studies indicate that Quar Oze-mediated TUSC2 overexpression in ALK+ NSCLC effectively curtails tumor growth and proliferation via activation of apoptotic pathways, providing a compelling rationale for progressing toward a clinical trial.

Annuncio • Aug 14

+ 1 more update

Genprex, Inc. Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer

Genprex, Inc. announced positive clinical study updates for its Acclaim-1 and Acclaim-3 clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), respectively, and plans to re-focus its oncology clinical development program. Patients in the Company's lung cancer clinical trials are being treated with the Company's lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy. Acclaim-1: The Acclaim-1 clinical trial is evaluating the combination of REQORSA and AstraZeneca's Tagrisso® to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso. The Acclaim-1 clinical trial has received an U.S. Food and Drug Administration (FDA) Fast Track Designation for late-stage NSCLC patients whose disease progressed after treatment with Tagrisso. Two patients from the Phase 1 dose escalation portion of the study have had prolonged PFS and are still continuing to receive treatment on the study. One of them has received the treatment combination of REQORSA and Tagrisso for more than two years. This patient, who was previously treated with Tagrisso and chemotherapy and who continues to receive REQORSA and Tagrisso treatment, attained a PR after the second course of REQORSA and Tagrisso, and has maintained this response for more than two years. The second patient has had stable disease without disease progression for more than 15 months, and is also continuing to receive REQORSA and Tagrisso treatment. The Phase 2a expansion portion of the study was designed to have two cohorts with 33 patients each. One cohort was for patients who have previously received only Tagrisso treatment, and one cohort was for patients who had previously received both Tagrisso treatment and chemotherapy. Based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, the Company has decided to limit its enrollment efforts moving forward to patients who received only prior Tagrisso treatment and to cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). The Phase 2a expansion portion of the trial with one cohort is now expected to enroll approximately 33 patients. The Phase 2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized 1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, will remain unchanged. Genprex will conduct an interim analysis following the treatment of 19 patients in the Phase 2a expansion portion who had previously received only Tagrisso treatment. The Company expects to complete the enrollment of the first 19 patients in the Phase 2a expansion portion of the study and conduct an interim analysis in the first half of 2025. Acclaim-3: The Acclaim-3 clinical trial is evaluating the combination of REQORSA and Genentech's Tecentriq® as a maintenance therapy to treat 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. The FDA has granted Fast Track Designation for the Acclaim-3 population of patients and has also granted Orphan Drug Designation for the treatment of SCLC. In this study, patients receive maintenance therapy with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Following completion of the Phase 1 dose escalation portion of the study, which the Company expects to complete during the second half of 2024, Genprex then expects to start the Phase 2 expansion portion of the study in the second half of 2024. The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial experienced an initial positive response after enrollment and dosing commenced in May. The patient had a PR, which is defined as at least a thirty percent (30%) decrease in tumor size, from the time the patient had a baseline CT scan after induction therapy and prior to the start of maintenance therapy, to the time of the CT scan performed after two cycles of maintenance therapy. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already received four cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, which suggests that REQORSA may be providing clinical benefit. A recent CT scan, performed after four cycles of maintenance therapy (three months), confirms that the patient had a 30% decrease in tumor size in measurable lesions; however one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at three months. Genprex's novel cancer treatment platform re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. The key component of REQORSA is a plasmid that expresses TUSC2, a tumor suppressor gene protein which plays a vital role in cancer suppression and normal cell metabolism. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression, thus restoring TUSC2 expression in SCLC has a strong biologic rationale. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein in combination with Tecentriq may lead to improved clinical efficacy in SCLC.

Indice di copertura degli interessi	n/a
Contanti	US$18.05m
Patrimonio netto	US$16.93m
Totale passività	US$3.38m
Totale attività	US$20.31m

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/06/17 21:48
Prezzo dell'azione a fine giornata	2026/06/17 00:00
Utili	2026/03/31
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Genprex Salute del bilancio

Criteri Salute finanziaria verificati 6/6

Informazioni chiave

Aggiornamenti recenti sulla salute finanziaria

Genprex, Inc. Receives Nasdaq Delisting Notice for Common Stock

Genprex Regains Compliance with the Bid Price Requirement and Receives Extension to Regain Compliance with Nasdaq Stockholders Equity Requirement

Genprex Inc Receives Exception to Regain Compliance with Nasdaq Listing Requirements

Genprex, Inc. Receives Non-Compliance Letter from Listing Qualifications Staff of the Nasdaq Stock Market

Genprex Confirms Regains Compliance with Nasdaq Listing Requirements

Genprex, Inc. announced delayed annual 10-K filing

Recent updates

Genprex, Inc. Receives Nasdaq Delisting Notice for Common Stock

Genprex, Inc. Announces Positive Clinical Data on Biomarkers in Patients Receiving Reqorsa® Gene Therapy Published at the 2026 ASCO Annual Meeting

Genprex Inc. Collaborators Present Positive Preclinical Data on Diabetes Gene Therapy for Type 2 Diabetes

Genprex Inc Receives Patent Grant from the Israel Patent Office for Combination of Reqorsa Gene Therapy and PD-1 Antibodies to Treat Cancer

Genprex Inc Announces Positive Clinical Data on Reqorsa Gene Therapy At Asco Annual Meeting

Genprex, Inc. Present Positive Preclinical Data on the Use of Reqorsa Gene Therapy for the Treatment of Lung Cancer

New major risk - Financial position

Genprex, Inc. to Present Positive Preclinical Data on Reqorsa Gene Therapy for Lung Cancer At the 2026 AACR Annual Meeting

Genprex Strengthens Intellectual Property Portfolio with Japanese and EU Patents for Reqorsa® Gene Therapy in Combination with Immunotherapies to Treat Cancer

Genprex, Inc. Announces Ip Australia's Intent to Grant Patent for Reqorsa®? Gene Therapy in Combination with Pd-L1 Antibodies to Treat Cancers

Genprex, Inc. Provides Clinical Update on Diabetes Gene Therapy Program

Genprex Regains Compliance with the Bid Price Requirement and Receives Extension to Regain Compliance with Nasdaq Stockholders Equity Requirement

Genprex, Inc. Announces the Publication of Data from Its Acclaim-1 Phase 1 Clinical Trial of Reqorsa®? Gene Therapy in Combination with Tagrisso®? (Osimertinib) in Patients with Advanced Non-Small Cell Lung Cancer

Genprex, Inc. Adds Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials

Genprex, Inc. has filed a Follow-on Equity Offering in the amount of $3.40002 million.

Genprex Collaborators Report Positive Preclinical Data on the Use of Reqorsa Gene Therapy for the Treatment of Lung Cancer At the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Genprex, Inc. has filed a Follow-on Equity Offering in the amount of $2.731003 million.

Genprex Inc Receives Exception to Regain Compliance with Nasdaq Listing Requirements

New major risk - Share price stability

Genprex, Inc. Receives Non-Compliance Letter from Listing Qualifications Staff of the Nasdaq Stock Market

Genprex, Inc. Receives Notice of Allowance for Multiple Patents for Reqorsa®? Gene Therapy with Pd-L1 and Pd-1 Antibodies to Treat Cancers

Genprex, Inc. has withdrawn its Follow-on Equity Offering.

Genprex, Inc., Annual General Meeting, Aug 15, 2025

Genprex Collaborators Present Positive Preclinical Research on Diabetes Gene Therapy At the 2025 American Diabetes Association 85Th Scientific Sessions

Genprex Collaborators Present Research on Non-Viral Approach to Diabetes Gene Therapy Using Lipid Nanoparticle Delivery System

Genprex Confirms Regains Compliance with Nasdaq Listing Requirements

Genprex Collaborators Present Positive Preclinical Data on Diabetes Gene Therapy at the ASGCT 28th Annual Meeting

Genprex, Inc. has filed a Follow-on Equity Offering.

Genprex Collaborators Report Positive Preclinical Data on the Use of Reqorsa®? Gene Therapy for the Treatment of Ras Inhibitor Resistant Lung Cancer At the 2025 Aacr Annual Meeting

Genprex Selects to Present Trial Design of Acclaim-3 Clinical Trial Evaluating Reqorsa®? Gene Therapy in Small Cell Lung Cancer at 2025 ASCO Annual Meeting

Genprex, Inc. announced delayed annual 10-K filing

Genprex Collaborators to Present Positive Preclinical Data on Diabetes Gene Therapy at the 2025 American Diabetes Association 85th Scientific Sessions

Genprex Collaborators Find NPRL2 Gene Therapy Using Oncoprex Delivery System Is a Potential Treatment for Anti-PD1 Resistant Non-Small Cell Lung Cancer

Genprex Receives a Letter from the Listing Qualifications Department of the Nasdaq Stock Market

Genprex, Inc. Announces First Patient Has Been Enrolled and Dosed in the Phase 2 Expansion Portion of the Company’S Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy

Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer

Genprex, Inc. Receives Notice from Nasdaq Regarding Non-Compliance with Stockholders' Equity Requirement

Genprex, Inc. Receives Safety Review Committee Approval to Advance to Highest Dose Group in Phase 1 Portion of Acclaim-3 Clinical Trial of Reqorsa Gene Therapy in Combination with Tecentriq in Extensive Stage Small Cell Lung Cancer

Genprex Receives Non-Compliance Notice from Nasdaq Regarding Minimum Bid Price Requirement

Genprex, Inc. Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer

New major risk - Shareholder dilution

No longer forecast to breakeven

New major risk - Financial position

Genprex Doses First Patient in Acclaim-3 Clinical Study of Reqorsa Immunogene Therapy in Combination with Tecentriq to Treat Small Cell Lung Cancer

Genprex, Inc Announces Executive Changes

New major risk - Shareholder dilution

Genprex, Inc., Annual General Meeting, Jun 18, 2024

Genprex Expands Clinical Trial Sites for Acclaim-3 Clinical Study of Reqorsa Therapy in Combination with Tecentriq to Treat Small Cell Lung Cancer

Genprex, Inc. has completed a Follow-on Equity Offering.

Genprex, Inc. has filed a Follow-on Equity Offering.

Genprex, Inc. Receives Notice of Patent Grant for Korean Patent Claiming Reqorsa Immunogene Therapy with PD-1 and PD-L1 Antibodies to Treat Cancers

Insufficient new directors

Genprex, Inc. Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators

Genprex, Inc. Announces First Patient Dosed in Phase 2a Expansion of Acclaim-1 Clinical Study of Reqorsa Therapy in Combination with Tagrisso to Treat Non-Small Cell Lung Cancer

New major risk - Market cap size

Genprex, Inc. to Present Data on the Use of Reqorsa for the Treatment of Lung Cancers At 2023 Aacr-Nci-Eortc International Conference on Molecular Targets and Cancer Therapeutics

Genprex Receives Non-Compliance Notice From Nasdaq

Genprex Appoints Suzanne Thornton-Jones as Senior Vice President, Regulatory Affairs

Genprex, Inc. announced delayed 10-Q filing

Can Genprex (NASDAQ:GNPX) Afford To Invest In Growth?

Genprex, Inc. Receives Fast Track Designation from the FDA for Its Small Cell Lung Cancer Drug Candidate

Genprex, Inc. Grants Chinese Patent for REQORSA(R) Immunogene Therapy in Combination with PD-1 Antibodies to Treat Cancers

Genprex Receives U.S. FDA Fast Track Designation for REQORSA Immunogene Therapy in Combination with Tecentriq for the Treatment of Small Cell Lung Cancer

Genprex, Inc. Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA(R) in Combination with Tagrisso(R) in Advanced Non-Small Cell Lung Cancer

Genprex, Inc. Publishes Positive Clinical Data from Phase 1 Portion of Acclaim-1 Clinical Trial Evaluating Reqorsa Immunogene Therapy in Non-Small Cell Lung Cancer

Genprex, Inc. announced delayed 10-Q filing

No longer forecast to breakeven

Here's Why We're Watching Genprex's (NASDAQ:GNPX) Cash Burn Situation

Price target increased to US$6.23