Reqorsa (quaratusugene ozeplasmid) / Genprex - LARVOL DELTA

Data from Genprex's Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer (PRNewswire) - "The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib...Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response....The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib."

P1 data • Non Small Cell Lung Cancer

Genprex…announced the Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in lung cancer (PRNewswire) - "In addition, the Company expects to add and open additional clinical trial sites for its Acclaim clinical trials over the coming months in an effort to expand its reach to additional patients and expedite enrollment....Genprex's team plans to conduct an interim analysis...[of] Acclaim-1...following the treatment of 19 patients, which the Company currently expects to complete enrollment of the first 19 patients in the first half of 2026.The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the...Acclaim-3...study in the first half of 2026."

Trial status • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Genprex, Inc…announced that the United States Patent and Trademark Office (USPTO) has granted Genprex a patent that covers the use of the Company’s lead drug candidate, Reqorsa Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq, through 2037. (PRNewswire) - "Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would also be applicable to Genprex's Acclaim-3 clinical trial....Genprex's team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026."

Patent • Trial status • Small Cell Lung Cancer

Genprex Announces European Patent Office's Intent to Grant a Patent 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, and Singapore."

Patent • Oncology

Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies (AACR-NCI-EORTC 2025) - "Non-Small Cell Lung Carcinoma (NSCLC) bearing the EML4-ALK fusion (Echinoderm microtubule-associated protein-like 4- Anaplastic Lymphoma Kinase) occurs in approximately 5% of NSCLC. We are also currently monitoring the mice for survival, and tumor measurements recorded at 2 weeks after the end of treatment indicate that tumors in mice that received single drug treatment are regrowing faster than tumors in mice that received combined treatment of QO and alectinib, further emphasizing the clinical relevance of this novel combination in ALK+ NSCLC. Taken together, our in vitro and in vivo data suggest that QO mediated overexpression of TUSC2 in ALK+ NSCLC is effective in decreasing growth and proliferation through the activation of apoptotic pathways, thereby paving the way for a potential clinical trial."

Late-breaking abstract • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CASP3 • CASP7 • EML4 • TUSC2

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 (PRNewswire) - "In the study researchers demonstrated that REQORSA can overexpress the tumor suppressor gene, TUSC2, in EML4-ALK+ NSCLC cell lines and patient derived organoids (PDOs). The upregulation of TUSC2 by REQORSA therapy induced apoptosis in ALK+ NSCLC cells, including those resistant to alectinib. Researchers also demonstrated that combining REQORSA with alectinib further increases apoptosis. Using in vivo mouse experiments with xenografts of a human ALK+-EML4 NSCLC cell line, treatment with REQORSA and alectinib together improved survival when compared to control. These experiments provide support for a trial of REQORSA in patients with ALK+-EML4 NSCLC."

Preclinical • Non Small Cell Lung Cancer

Genprex Announces Positive Preclinical Data for Reqorsa Gene Therapy (TradingView) - "Reqorsa showed 79% tumor reduction in ALK+ NSCLC models; Combination with alectinib improved outcomes by 23% over 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 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics (PRNewswire) - "The collaborators will present positive preclinical data from a study of Genprex's lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of ALK-EML4 positive non-small cell lung cancer (NSCLC)."

Preclinical • Non Small Cell Lung Cancer

Genprex Receives Notice of Allowance for Multiple Patents for Reqorsa Gene Therapy with PD-L1 and PD-1 Antibodies to Treat Cancers (PRNewswire) - "...U.S. Patent and Trademark Office has issued...Similarly, the European Patent Office has issued a Notice of Allowance to Genprex for a patent covering the use of REQORSA in combination with PD-1 antibodies....Both patents will expire in 2037 at the earliest."

Patent • Small Cell Lung Cancer

A phase 1/2 clinical trial of quaratusugene ozeplasmid gene therapy and atezolizumab maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC). (ASCO 2025) - P1/2 | " Eligible patients have ES-SCLC and have completed 3-4 cycles of induction therapy with etoposide, a platinum agent, and atezo without disease progression, and are thus eligible for maintenance therapy...Dexamethasone, acetaminophen, and diphenhydramine are given prior to each treatment to prevent delayed infusion-related reactions...The Phase 2 portion of the trial opened for enrollment in December, 2024. (NCT05703971)."

Clinical • Gene therapy • P1/2 data • Gene Therapies • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • TUSC2

Genprex to Present Trial Design of Acclaim-3 Clinical Trial Evaluating Reqorsa Gene Therapy in Small Cell Lung Cancer at 2025 ASCO Annual Meeting (PRNewswire) - "The Company will present the trial design of the Acclaim-3 Phase 1/2 clinical trial evaluating Genprex's lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in combination with Tecentriq as maintenance therapy for the treatment of extensive stage small cell lung cancer (ES-SCLC)....Eligible patients have ES-SCLC and have completed 3-4 cycles of induction therapy with etoposide, a platinum agent, and Tecentriq without disease progression, and are thus eligible for maintenance therapy. REQORSA is administered via IV every 21 days in escalating dose cohorts in Phase 1 and Tecentriq 1200 mg is also administered via IV every 21 days....The Phase 2 portion of the trial will enroll 50 patients which provides 80% power at a one-sided alpha level of 0.05 to detect an 18-week PFS rate of 52% compared to a historical 18-week PFS rate of 34% with Tecentriq alone."

Clinical protocol • Small Cell Lung Cancer

Genprex Signs Exclusive License to Additional Gene Therapy Technology with UTHealth Houston for the Treatment of Glioblastoma (PRNewswire) - "Genprex, Inc...announced it has entered into an exclusive patent license agreement with UTHealth Houston granting Genprex exclusivity and commercial rights relating to its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid) for the potential treatment of glioblastoma. The subject patent is co-owned by Genprex and UTHealth Houston, and the license provides Genprex with patent exclusivity."

Licensing / partnership • Glioblastoma

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 (PRNewswire) - "Genprex, Inc...announced that its research collaborators presented positive preclinical data for Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC)....The data indicate that TUSC2 transfection significantly reduced colony formation and markedly increased apoptosis in two AR cell lines. Re-expression of TUSC2 in AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models."

Preclinical • Non Small Cell Lung Cancer

Genprex Signs Exclusive Technology License Agreement with New York University Langone Health for the Treatment of Mesothelioma (PRNewswire) - "Genprex, Inc...announced it has signed an exclusive patent license agreement with NYU Langone Health related to the drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid). The therapy is under investigation as a potential treatment for mesothelioma. The subject patent is co-owned by Genprex and NYU Langone Health, and the license provides Genprex with patent exclusivity."

Patent • Mesothelioma

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

Genprex Selected to Present Trial Design of Acclaim-3 Clinical Trial Evaluating Reqorsa Gene Therapy in Small Cell Lung Cancer at 2025 ASCO Annual Meeting (PRNewswire) - "Genprex, Inc...today announced that it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois and online. Genprex's abstract was selected for a poster presentation for the Trials in Progress portion of the conference. The Company will present the trial design of the Acclaim-3 Phase 1/2 clinical trial evaluating Genprex's lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in combination with Tecentriq as maintenance therapy for the treatment of extensive stage small cell lung cancer (ES-SCLC)."

Clinical protocol • Small Cell Lung Cancer

Genprex Announces Research Collaborators' Abstract Published in Cancer Research Supplement Proceedings (GlobeNewswire) - "Genprex collaborators will present the published abstract in a poster presentation at the 2025 AACR Annual Meeting being held April 25-30, 2025 in Chicago, Illinois. The collaborators will present positive preclinical data from a study of Genprex's lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC)."

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 2025 AACR Annual Meeting (PRNewswire) - "Genprex, Inc...today announced that its research collaborators will present at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois. The collaborators will present positive preclinical data from a study of its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC)."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer

Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov) - P1/2 | N=5 | Terminated | Sponsor: Genprex, Inc. | N=180 ➔ 5 | Trial completion date: Dec 2025 ➔ Feb 2025 | Active, not recruiting ➔ Terminated; Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.

Enrollment change • Trial completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Genprex Announces First Patient Dosed in Phase 2 Expansion Portion of Acclaim-3 Clinical Study of Reqorsa Gene Therapy in Combination with Tecentriq to Treat Small Cell Lung Cancer (PRNewswire) - "Genprex...announced that the first patient has been enrolled and dosed in the Phase 2 expansion portion of the Company's Acclaim-3 clinical study of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC)....The Phase 2 expansion portion will enroll 50 patients at approximately 10 to 15 U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced....A Phase 2 interim analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients in the second half of 2025 for interim analysis."

Trial status • Small Cell Lung Cancer

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 (PRNewswire) - "Genprex, Inc...today announced that it has completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq (atezolizumab) as maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC)....Based on full safety data, which showed no dose limiting toxicities (DLTs), the SRC determined that the Recommended Phase 2 Dose (RP2D) of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion of the trial. The SRC also recommended the trial advance to the Phase 2 expansion portion of the study, which the Company has now opened for enrollment....Additionally, we will be submitting the results of the Phase 1 portion of the study to a clinical meeting and anticipate data presentation in 2025, and we remain encouraged by the early efficacy demonstrated in ES-SCLC patients."

DSMB • P1 data • Trial status • Lung Cancer • Small Cell Lung Cancer

TUSC2 gene therapy in KRASG12C mutant NSCLC overcomes acquired resistance to sotorasib (EORTC-NCI-AACR 2024) - "These resistant cells also showed resistance to adagrasib, 2nd KRASi. The antitumor immune responses of quaratusugene ozeplasmid on TC314AR PDX tumors are currently being evaluated in the humanized mouse model. In Conclusion, TUSC2 therapy, alone or in combination with sotorasib induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant acquired resistant xenograft and PDX tumors."

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

Efficacy of Quaratusugene Ozeplasmid TUSC2 Gene Therapy in Glioblastoma (EORTC-NCI-AACR 2024) - "Quaratusugene ozeplasmid (Quar Oze), TUSC2 plasmid DNA complexed with DOTAP-Cl: Cholesterol liposome solution, has been tested in lung cancer clinical trials including ONC-001, ONC-002, and active Acclaim-1 Phase II trial with osimertinib, Acclaim-2 Phase 1/2 trial with pembrolizumab, and Acclaim-3 Phase 1/2 study with atezolizumab. We report, for the first time, that Quar Oze demonstrates promising in vitro efficacy in GBM and PD-GSCs. These results serve as supporting evidence for further evaluation of its in vivo anti-tumor efficacy in malignant gliomas using mouse models.Table 1: Quar Oze Effects on GBM Cells Quar Oze Effects Over Controls P-Values Proliferation Decreased 45% <0.0001 Glioma Stem Cells Decreased 63% 0.017 Apoptosis Increased 32% 0.0029 Cell Migration Decreased 70% <0.0001"

Clinical • Gene therapy • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Oncology • Solid Tumor • ANXA5 • NEDD4 • TUSC2

Genprex Signs Exclusive License to Additional Gene Therapy Technologies with the University of Michigan for the Treatment of Lung Cancer (PRNewswire) - "Genprex, Inc...announced it has entered into an exclusive license agreement with the University of Michigan, granting Genprex a worldwide, exclusive license to the University's patent rights relating toits lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in combination with ALK-inhibitors for the potential treatment of ALK-EML4 positive translocated lung cancer."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Tusc2 modulates cancer immune responses (SITC 2024) - "Experimental group was iv injected with Tusc2-expressing lipoparticles (quaratusugene ozeplasmid, provided by Geneprex, Inc); control group of Tusc2 KO mice was i.v. injected with saline solution...Conclusions This research demonstrated the capacity of quar oze supplementation to Tusc2-deficient mice to modulate immune cells within the TME. Tusc2-dependent changes in immune composition correlated with the reduction in tumor size in quar oze treated group, indicating that Tusc2 lipoparticles may carry anti-tumor potential even in individuals with low Tusc2 expression due to aging, chronic inflammation, metabolic diseases, etc."

IO biomarker • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • GZMB • TUSC2