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Genprex, Inc. (NASDAQ: GNPX) is a pioneering clinical-stage gene therapy company committed to transforming the landscape of cancer and diabetes treatments. The company's mission is to address the unmet medical needs of a growing population of patients worldwide through the development of innovative immunogene therapies. Genprex's flagship product, Reqorsa Immunogene Therapy (quaratusugene ozeplasmid), is at the forefront of its oncology program and is currently being evaluated in three clinical trials targeting non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
Oncoprex® Delivery System, Genprex's proprietary platform, encapsulates gene-expressing plasmids using lipid-based nanoparticles. This systemic, non-viral method enables the intravenous delivery of tumor suppressor genes to cancer cells, which then express proteins that were deficient in the tumor. Reqorsa Immunogene Therapy has shown promise by re-establishing pathways for programmed cell death, interrupting cancer cell signaling, and modulating immune responses.
The company's recent achievements include securing new patents and receiving FDA Fast Track and Orphan Drug designations for its clinical programs. Specifically, the Acclaim-2 and Acclaim-3 studies are exploring the potential of Reqorsa in combination with immune checkpoint inhibitors like Keytruda® and Tecentriq®. These trials aim to provide new therapeutic options for patients with advanced-stage lung cancers who have limited treatment alternatives.
In addition to its oncology initiatives, Genprex is advancing a novel gene therapy approach for diabetes. Using an AAV vector, the company delivers Pdx1 and MafA genes directly to the pancreas to transform alpha cells into beta-like cells capable of producing insulin. This method shows promise for both Type 1 and Type 2 diabetes and aims to offer a new lifeline for patients with these conditions.
Genprex collaborates with renowned institutions and industry leaders to further its research and development pipeline. The company's commitment to innovation and patient-centric solutions positions it as a significant player in the gene therapy landscape.
Latest News:
- March 12, 2024 - Genprex announces new patent grants in South Korea for Reqorsa® Immunogene Therapy.
- March 19, 2024 - Genprex enters into agreements for the sale and issuance of shares, expecting gross proceeds of $6.5 million.
- April 2, 2024 - Positive preclinical data for NPRL2 gene therapy presented at AACR Annual Meeting.
- April 3, 2024 - Multiple new trial sites added for Acclaim-3 study in extensive-stage small cell lung cancer.
- April 9, 2024 - Research collaborators present positive preclinical data supporting Reqorsa and NPRL2 therapies.
- May 8, 2024 - Genprex announces the passing of its co-founder and CEO Rodney Varner.
- May 14, 2024 - First patient dosed in Phase 1 of Acclaim-3 clinical study for Reqorsa® and Tecentriq® combination therapy.
Genprex (NASDAQ: GNPX) has formed a Mesothelioma Clinical Advisory Board to support its preclinical mesothelioma oncology program. The board consists of four renowned researchers specializing in mesothelioma treatment. This initiative aims to advance Genprex's Reqorsa® Gene Therapy, which uses the TUSC2 tumor suppressor gene. TUSC2 expression is downregulated in 84% of mesotheliomas, and Genprex's collaborators will present additional positive preclinical data next month at the 2024 EORTC-NCI-AACR Symposium.
Reqorsa® uses Genprex's Oncoprex® Delivery System to target cancer cells while minimizing uptake by normal tissue. Mesothelioma affects approximately 3,000 new cases annually in the U.S., with a life expectancy of 18 months for pleural mesothelioma and a 3-year survival rate of 23% with treatment.
Genprex (NASDAQ: GNPX) announced that its research collaborators will present positive preclinical data on Reqorsa® Gene Therapy at the 2024 EORTC-NCI-AACR Symposium. The presentations will focus on Reqorsa as a potential treatment for Ras inhibitor resistant lung cancer, mesothelioma, and glioblastoma. Three posters will be presented, showcasing studies conducted with academic partners.
Genprex has filed two provisional patent applications based on the data, one for treating mesothelioma and another for glioblastoma. The company is co-owner of these applications with the respective institutions. Reqorsa uses the TUSC2 tumor suppressor gene encapsulated in non-viral lipid-based nanoparticles, designed to target cancer cells while minimizing uptake by normal tissue.
Genprex (NASDAQ: GNPX) has announced plans to create a new subsidiary focused on developing GPX-002, a gene therapy for Type 1 and Type 2 diabetes. This move aims to separate the diabetes program from Genprex's oncology portfolio, potentially attracting more investors and expediting clinical development. The spin-out is expected to occur by the end of 2024, subject to financing and board approval.
The new company would become a pure-play diabetes-focused biopharmaceutical entity, while Genprex would concentrate on oncology. GPX-002, licensed from the University of Pittsburgh, uses an AAV vector containing Pdx1 and MafA genes administered directly into the pancreatic duct. This approach could potentially replace daily blood glucose monitoring and insulin therapy, as well as GLP-1 treatments in Type 2 diabetes.
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, has announced its participation in two major investor and industry conferences in September 2024. The company will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-13, with an on-demand virtual presentation by Ryan Confer, Genprex's President, CEO, and CFO, available from September 9-11.
Additionally, Genprex will attend Chardan's 8th Annual Genetic Medicines Conference from September 30 to October 1 in New York City. Thomas Gallagher, Senior VP of Intellectual Property and Licensing, will be available for in-person meetings at this event. These presentations will highlight Genprex's innovative gene therapies for cancer and diabetes, offering investors insights into the company's progress and potential.
Genprex (NASDAQ: GNPX) has released a new video featuring Chief Medical Officer Dr. Mark Berger discussing positive patient outcomes in two lung cancer clinical trials. The Acclaim-1 trial, evaluating Reqorsa® Gene Therapy with Tagrisso® for late-stage NSCLC, showed remarkable prolonged Progression Free Survival in two patients. In the Acclaim-3 trial, testing Reqorsa with Tecentriq® for extensive stage small cell lung cancer, the first patient achieved a partial remission during maintenance therapy.
Dr. Berger highlighted the significance of these results and announced updates to the oncology clinical development program. Genprex is streamlining its efforts by removing a cohort in Acclaim-1's Phase 2a and closing Acclaim-2 to further enrollment due to slow recruitment. The company aims to focus resources on advancing Reqorsa through the clinic efficiently.
Genprex (NASDAQ: GNPX) announced positive updates for its Acclaim-1 and Acclaim-3 clinical trials treating non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) with Reqorsa® Gene Therapy. In Acclaim-1, two patients showed prolonged Progression Free Survival, with one maintaining a Partial Remission for over two years. The first patient in Acclaim-3 achieved a Partial Remission during maintenance therapy.
Genprex is refocusing its oncology program, discontinuing Acclaim-2 and limiting Acclaim-1's Phase 2a to patients with prior Tagrisso treatment only. The company expects to complete enrollment for Acclaim-1's Phase 2a first 19 patients and conduct an interim analysis in H1 2025. Acclaim-3's Phase 2 expansion is anticipated to start in H2 2024.
Genprex is also collaborating with an academic partner to develop biomarkers for patient selection and treatment response prediction.
Genprex (NASDAQ: GNPX) has been granted a patent in Singapore for its lead drug candidate, Reqorsa® Gene Therapy, in combination with anti-PD-1 antibodies for cancer treatment. This patent, valid through 2037, expands on previously granted patents in other countries and covers the use of REQORSA with immune checkpoint inhibitors. The company plans to pursue additional patents for REQORSA combined with PD-L1 antibodies in various countries, which could apply to their Acclaim-3 clinical trial.
The patent strengthens Genprex's intellectual property portfolio, particularly in Asian markets where lung cancer is prevalent. In 2022, Asia accounted for 63% of new lung cancer cases worldwide. The Acclaim-3 study, a Phase 1/2 clinical trial, combines REQORSA with Genentech's Tecentriq® for extensive stage small cell lung cancer (ES-SCLC) patients. This trial has received FDA Fast Track Designation and Orphan Drug Designation.
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, will present at the Sidoti Microcap Conference on August 15, 2024, at 8:30 am ET. Ryan Confer, the company's President, CEO, and CFO, will provide an overview of Genprex's gene therapies for cancer and diabetes.
The virtual presentation will highlight the company's pioneering work in developing life-changing therapies. Investors can access the presentation through a provided link and schedule virtual meetings with Mr. Confer. An archive of the presentation will be available on the company's website in the Investor Relations section.
This conference appearance underscores Genprex's commitment to advancing its innovative gene therapy pipeline and engaging with the investment community.
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, announced significant achievements in its 2024 stockholder letter. The company has initiated two new lung cancer clinical trials and continues treating patients in an ongoing trial. By partnering with community-based oncology practices, Genprex aims to extend its clinical reach. They have also expanded preclinical research into new therapeutic areas, showcasing positive results at a major cancer conference. Additionally, their global intellectual property portfolio has been strengthened to protect their lead drug candidate. Genprex is optimistic about upcoming catalysts that will enhance its position in gene therapy.
Genprex, a clinical-stage gene therapy company, announced its participation in the 2024 BIO International Convention, set to take place from June 3-6, 2024, at the San Diego Convention Center. The company's President, CEO, and CFO, Ryan Confer, will present on June 3 at 2:00 p.m. PT. The presentation will cover Genprex's gene therapies for cancer and diabetes. Attendees can request one-on-one meetings through the conference portal or by contacting Investor Relations.
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