Core Insights - Genprex, Inc. announced significant findings regarding NPRL2 gene therapy's effectiveness in treating anti-PD1 resistant non-small cell lung cancer (NSCLC) using a non-viral delivery system [1][2][3] - The study demonstrated that NPRL2 gene therapy alone produced a dramatic antitumor effect, while pembrolizumab (Keytruda®) was ineffective on its own [2][3] - The Oncoprex® Delivery System, which utilizes lipid nanoparticles, allows for the intravenous delivery of tumor suppressor genes, minimizing toxicity risks associated with viral systems [1][4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its non-viral Oncoprex® Delivery System [5][6] - The company's lead product, Reqorsa® Gene Therapy, is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [5][6] - Genprex's oncology programs have received Fast Track Designation from the FDA, and the SCLC program has received Orphan Drug Designation [6] Research Findings - The NPRL2 gene therapy showed greater antitumor effects in humanized mice compared to non-humanized NSG mice, indicating the role of the immune system in its efficacy [3] - The therapy targets KRAS/STK11 mutant tumors, which are known to be resistant to conventional treatments, suggesting potential applicability to approximately 30% of NSCLCs with KRAS mutations [3]

Core Insights - Genprex, Inc. has initiated the Phase 2 expansion of the Acclaim-3 clinical study for Reqorsa® Gene Therapy in combination with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC) patients [1][2] - The study aims to determine the 18-week progression-free survival (PFS) rate, with a median PFS of 5.2 months for ES-SCLC and 2.6 months for those receiving Tecentriq as maintenance therapy [2] - The FDA has granted Fast Track and Orphan Drug Designations for Reqorsa, indicating its potential significance in treating SCLC [3] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a novel cancer treatment platform that re-expresses tumor suppressor genes [4][7] - The lead product candidate, Reqorsa, is being evaluated in clinical trials for both non-small cell lung cancer (NSCLC) and SCLC, with Fast Track Designation from the FDA for both programs [8] Clinical Study Details - The Acclaim-3 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with Tecentriq as maintenance therapy for ES-SCLC patients who did not progress after initial treatment [6] - The Phase 2 expansion will enroll 50 patients across 10 to 15 U.S. sites, with an interim analysis planned after the first 25 patients complete 18 weeks of follow-up [2][5] Research Findings - Data from studies presented at the October 2023 AACR-NCI-EORTC conference indicate that the combination of Reqorsa and Tecentriq shows significantly better tumor control compared to either agent alone [5]

Core Viewpoint - Genprex, Inc. is actively participating in the 43rd Annual J.P. Morgan Healthcare Conference to engage with investors and industry stakeholders regarding its gene therapies for cancer and diabetes [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [4]. - The company’s lead product candidate, Reqorsa® Gene Therapy, is under evaluation in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received Fast Track Designation from the FDA [4]. - Genprex's diabetes gene therapy, GPX-002, aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin, targeting both Type 1 and Type 2 diabetes [4]. Conference Participation - Key executives from Genprex, including the President, CEO, and Chief Medical Officer, will be available for one-on-one meetings during the conference to discuss the company's gene therapies [2][3].

Core Insights - Genprex has completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial for Reqorsa® Gene Therapy in combination with Tecentriq® for treating extensive stage small cell lung cancer (ES-SCLC) [1][9] - The Safety Review Committee (SRC) has approved the transition to the Phase 2 expansion portion of the trial, which is now open for enrollment [1][3] Company Developments - The combination of Reqorsa and Tecentriq has received FDA Fast Track Designation and Orphan Drug Designation for SCLC treatment [2] - The Recommended Phase 2 Dose (RP2D) of Reqorsa is set at 0.12 mg/kg, the highest dose level from Phase 1, with no dose limiting toxicities reported [3][6] - The Phase 2 expansion will enroll approximately 50 patients across 10 to 15 U.S. sites, focusing on the 18-week progression-free survival rate as the primary endpoint [7] Clinical Trial Insights - The Phase 1 trial demonstrated a partial remission in the first patient treated, with a 30% decrease in tumor size after four cycles of maintenance therapy [4] - Data from humanized mouse models indicate that the combination of Reqorsa and Tecentriq significantly improves tumor control compared to either agent alone [8] - The Acclaim-3 trial is designed to evaluate Reqorsa as maintenance therapy for patients who did not experience tumor progression after initial treatment [9] Future Outlook - The company anticipates promising enrollment rates for the Phase 2 portion of the trial and plans to present Phase 1 results at a clinical meeting in 2025 [4] - Genprex is focused on developing innovative therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene therapy applications [10]

Core Viewpoint - Genprex, Inc. has entered into an exclusive license agreement with the University of Michigan for its lead drug candidate, Reqorsa® Gene Therapy, in combination with ALK-inhibitors for the treatment of ALK-positive lung cancer [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its ONCOPREX® Delivery System to administer disease-fighting genes [6]. - The company is currently evaluating Reqorsa® Gene Therapy in two clinical trials for non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC), both of which have received Fast Track Designation from the FDA [6]. Product Details - Reqorsa® Gene Therapy (quaratusugene ozeplasmid) targets cancer cells by delivering the TUSC2 gene using non-viral nanoparticles, aiming to interrupt cancer cell signaling and promote apoptosis [4]. - The therapy has shown positive preclinical data, indicating its potential effectiveness in treating ALK-positive lung cancer, particularly in patients resistant to alectinib [2][3]. Research and Development - Research at the University of Michigan has demonstrated that Reqorsa can decrease cell growth and proliferation in ALK-positive NSCLC cell lines by activating apoptotic pathways [3]. - The company believes that Reqorsa may be an effective treatment for patients progressing on ALK inhibitors, supporting further clinical studies [3]. Intellectual Property Strategy - Genprex is enhancing its intellectual property portfolio for Reqorsa, which may benefit patients with various types of cancers, thereby widening its exclusivity for drug combinations [2].

Clinical Trials - The company is currently enrolling and treating patients in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial, which combines REQORSA and Tecentriq for extensive stage small cell lung cancer (ES-SCLC) patients [111]. - In the Acclaim-3 trial, the first patient treated experienced a partial remission, defined as at least a 30% decrease in tumor size after two cycles of maintenance therapy [111]. - The FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq in June 2023, and Orphan Drug Designation for REQORSA for SCLC in August 2023 [111]. - The Acclaim-1 trial is currently in the Phase 2a expansion portion, using REQORSA and Tagrisso in late-stage NSCLC patients, with the recommended Phase 2 dose set at 0.12 mg/kg [114]. - The Acclaim-1 trial has shown prolonged progression-free survival in two patients, with one maintaining a partial remission for approximately 30 months [114]. - The Phase 2a expansion portion of the Acclaim-1 study is expected to enroll approximately 33 patients, focusing on those who received only prior Tagrisso treatment [114]. - The company decided to cease enrollment in the Acclaim-2 trial to prioritize resources for the Acclaim-1 and Acclaim-3 trials due to enrollment challenges [112]. - The company plans to conduct clinical trials for its Acclaim-1 and Acclaim-3 programs, with enrollment for the first 19 patients in Acclaim-1 expected in the first half of 2025 [148]. Financial Performance - The company reported a net loss of $4,315,987 for the three months ended September 30, 2024, a decrease of 44% compared to a net loss of $7,748,243 for the same period in 2023 [139]. - For the nine months ended September 30, 2024, the net loss was $16,780,701, representing a decrease of 33% from $24,931,209 in 2023 [140]. - As of September 30, 2024, the company had an accumulated deficit of $150,468,981 and has never generated revenue from product sales [141]. - Net cash used in operating activities decreased to $13,279,658 for the nine months ended September 30, 2024, down 33% from $19,774,740 in 2023 [151]. - The company provided $1,167 in net cash from investing activities for the nine months ended September 30, 2024, compared to a net cash outflow of $61,383 in 2023 [152]. - Net cash provided by financing activities was $8,029,143 for the nine months ended September 30, 2024, a decrease of $2,564,230 from $10,593,373 in 2023 [153]. - The company expects to fund its operations and clinical trials into December 2024 based on current cash levels [149]. Research and Development - The company has entered into a three-year sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes [110]. - The oncology platform utilizes the Oncoprex® Delivery System to deliver tumor suppressor gene-expressing plasmids to cancer cells, administered intravenously [108]. - The company is in early stages of discovery programs to identify other cancer candidates that can be delivered using the ONCOPREX Delivery System [110]. - Research and Development (R&D) expense for Q3 2024 was $2,756,081, a decrease of 40% from $4,616,546 in Q3 2023 [131]. - R&D expense for the nine months ended September 30, 2024 was $7,696,982, down 45% from $13,903,611 in the same period of 2023 [132]. General and Administrative Expenses - General and Administrative (G&A) expense for Q3 2024 was $1,566,085, a decrease of 51% from $3,166,057 in Q3 2023 [133]. - G&A expense for the nine months ended September 30, 2024 was $9,135,225, down 18% from $11,173,643 in the same period of 2023 [134]. Interest and Depreciation - Interest income for Q3 2024 was $8,080, a decrease of $43,311 from $51,391 in Q3 2023 [135]. - Interest income for the nine months ended September 30, 2024 was $58,851, down $116,562 from $175,413 in the same period of 2023 [136]. - Depreciation expense for Q3 2024 was $1,272, a decrease of 66% from $3,724 in Q3 2023 [137]. - Depreciation expense for the nine months ended September 30, 2024 was $6,230, down 46% from $11,578 in the same period of 2023 [138]. Workforce Reduction - The company has reduced its workforce from 31 employees at September 30, 2023, to 19 employees at September 30, 2024, as part of its expense reduction strategies [139]. Future Plans - The company plans to request further regulatory guidance from the FDA in the first half of 2025 regarding nonclinical studies for its diabetes gene therapy product candidates [116]. - The company is considering transferring its diabetes clinical development program and gene therapy assets into a new wholly-owned subsidiary by the end of 2024, subject to financing and approvals [116]. - The company sold 2,318,450 shares of common stock for net proceeds of $2,117,752 during the nine months ended September 30, 2024 [143].

Core Insights - Genprex, Inc. announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, which modulates immune responses against cancer [1][2] - The findings will be presented at the 39th Annual Society for Immunotherapy of Cancer Meeting, indicating the growing evidence of Reqorsa's anti-tumor mechanisms [2][4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System [7][8] - The company collaborates with academic institutions to advance its drug candidates and has received Fast Track Designation and Orphan Drug Designation from the FDA for its lung cancer programs [8] Research Findings - The study involved TUSC2 Knock Out (KO) and Wild Type (WT) mice, analyzing immune responses through flow cytometry [2][3] - In the Reqorsa supplemented group, tumor growth was significantly reduced, with a notable decrease in T regulatory cells and an increase in Cytotoxic T cells and NK cells [3][4] - The research suggests that Reqorsa can enhance immune responses against tumors, even in individuals with low TUSC levels due to various health conditions [4][5] Product Details - Reqorsa consists of a TUSC2 gene expressing plasmid encapsulated in lipid-based nanoparticles, specifically targeting cancer cells while minimizing normal tissue uptake [5][8] - Laboratory studies indicate that the uptake of TUSC2 in tumor cells post-Reqorsa treatment is 10 to 33 times higher than in normal cells [5] Future Developments - Following the conference, the poster detailing the research will be available for download on Genprex's website [6]

AUSTIN, Texas, Oct. 31, 2024 /PRNewswire/ -- 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, today announced its participation in the upcoming BIO Europe Conference, taking place Nov. 4-6, 2024 in Stockholm, Sweden and taking place virtually Nov. 12-13, 2024.Attending in-person will be Genprex's Senior Vice President of Intellectual Property and Licensing, Thomas Gallagher, E ...

Preclinical Data Presented at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics AUSTIN, Texas , Oct. 28, 2024 /PRNewswire/ -- 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, today announced that research collaborators delivered poster presentations at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics held October 23-25 ...

Research to Study TUSC2 Combined with ALK-InhibitorsCollaboration with Non-Profit Patient-Focused Research Group Expands Potential Lung Cancer Patient Population for Reqorsa® Gene TherapyAUSTIN, Texas , Oct. 24, 2024 /PRNewswire/ -- 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, today announced the Company has entered into a Sponsored Research Agreement (SRA) with the Univer ...