Golden Cross
1 month ago
Genprex Provides Update on Diabetes Gene Therapy Program
February 18, 2025 Press ReleasesDiabetesgene therapy
Signs an Amended & Restated License Agreement for Multiple Technologies for Gene Therapy for Type 1 and Type 2 Diabetes
Forms a Wholly-Owned Subsidiary, Convergen Biotech, Inc., to Focus Diabetes Program Development
AUSTIN, Texas — (Feb. 18, 2025) —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 advancement of its diabetes gene therapy program, including its relationship and collaboration with the University of Pittsburgh of the Commonwealth System of Higher Education (Pitt).
The parties have updated and consolidated the Company’s existing license agreements for technologies from Pitt into a new exclusive license agreement for multiple technologies relating to the development of a gene therapy product for both T1D and T2D. Additionally, the Company has formed a wholly-owned subsidiary, Convergen Biotech, Inc., which will focus on the Company’s diabetes program development.
“We are excited about the advances we are making with our diabetes gene therapy program, including the updated, consolidated exclusive license agreement with the University of Pittsburgh for several technology combinations,” said Ryan Confer, President and Chief Executive Officer at Genprex. “We are also pleased to have formed our wholly-owned subsidiary. In addition, we’re having ongoing discussions with various patient advocacy groups. We believe GPX-002 is a highly innovative, emerging diabetes gene therapy, and we are working to advance this program toward human clinical trials.”
Exclusive License Agreement with the University of Pittsburgh
The new license agreement consolidates the Company’s licensed technologies from Pitt into a single updated agreement which replaces the existing license agreements with Pitt. The amended and restated agreement grants Genprex a worldwide, exclusive license to patent applications and related technologies and a worldwide, non-exclusive license to use certain related know-how, all related to a gene therapy for both T1D and T2D using the genes of the Pdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters. This license creates a comprehensive panel of gene therapies exclusively licensed by Genprex for the Company’s diabetes gene therapy program.
“The latest exclusive license agreement synergizes our pre-existing relationship with the University of Pittsburgh, strengthens our intellectual property portfolio for the diabetes gene therapy program and provides Genprex with valuable rights over multiple diabetes gene therapy combinations that we believe have the potential to disrupt the diabetes market,” said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. “These technologies are currently being evaluated in preclinical studies at the University of Pittsburgh. As we continue to optimize our construct, we are making strides toward clinical trials.”
The licensed technologies are based on the same general gene therapy approach under Genprex’s original licenses, whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. GPX-002 is being developed using the same construct for the treatment of both T1D and T2D. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for T2D, where autoimmunity is not a factor, is believed to rejuvenate and replenish exhausted beta cells.
Each of these technologies may have the potential to provide long-term efficacy, potentially changing the course of this disease for the millions of patients around the world with diabetes. All of the diabetes technologies licensed from Pitt by Genprex were developed in the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine.
The Company has finalized components of the diabetes construct and is continuing with its planned preclinical studies. Genprex plans to request FDA’s guidance for the preclinical studies needed to file an Investigational New Drug (IND) application and initiate first-in-human studies and is poised for FDA Guidance on IND-enabling diabetes studies by the second half of 2025.
Formation of a Wholly-Owned Subsidiary
In addition, as announced in September 2024, Genprex believes separating its diabetes program from its oncology program into a new, wholly-owned subsidiary could expedite clinical development and enable potential direct investment and strategic collaboration into its diabetes program. In connection with the intended separation of its diabetes clinical development program, Genprex has formed a wholly-owned subsidiary, Convergen Biotech, Inc. Genprex believes implementing this initial step and facilitating the separation of its diabetes program into Convergen Biotech will allow both Genprex and Convergen Biotech to enhance each program’s focus on meeting the needs of their respective markets and patients. The decision to implement this initial step of the reorganization demonstrates Genprex’s strong ongoing commitment to the Company’s streamlined, focused strategies and prioritization of its ongoing research and development prioritization initiative.
About Diabetes
According to the U.S. Center for Disease Control as of 2024, 38.4 million Americans, or approximately 11.6% of the U.S. population, have diabetes. Approximately 10% of this total has T1D and approximately 90-95% of this total has T2D. It is also believed that more than 97 million Americans aged 18 years or older have prediabetes. In 2021, approximately 537 million adults (20-79 years) worldwide were living with diabetes, and the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million in 2045. Approximately 7.7 million adults over the age of 20 live with T1D worldwide, and approximately 1.6 million children and adolescents under the age of 20 live with T1D worldwide. Also in 2021, diabetes caused more than 6.7 million deaths globally and diabetes resulted in approximately $966 billion dollars in health expenditures, a 316% increase over the preceding fifteen years.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
Golden Cross
1 month ago
Company’s CEO and CFO Highlights its Cutting-Edge Gene Therapy Programs
AUSTIN, Texas — (Sept. 23, 2024) — 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’s President, Chief Executive Officer and Chief Financial Officer, Ryan Confer, was featured in CEO/CFO Magazine discussing the Company’s novel gene therapies for cancer and diabetes.
In this article, Confer describes the Company’s gene therapy approaches in oncology and diabetes, recent updates to the Company’s Acclaim clinical trials in lung cancer, and the Company’s new use of biomarker testing for its oncology program. In diabetes, Confer comments on the popularity of GLP-1 agonists such as Novo Nordisk’s Ozempic® and other new diabetic treatments, the future of potential partnerships and collaborations in gene therapy and for Genprex, and the medical and investment community’s understanding of the potential value of gene therapy for diabetes.
Confer states in the CEO Magazine article:
“One thing we are excited about – as we just recently announced – is our plan to launch a spin out of our diabetes program into a wholly-owned subsidiary of Genprex. We believe this will allow us to explore potential partnerships with those entities solely focused on the diabetes program and find the right funding, partners, and collaborators that could drive these programs forward, which is important to us in terms of getting these innovative drugs to patients faster and to creating value for our stakeholders.”
To read the article in its entirety, please visit the Media Coverage section on Genprex’s website.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
georgie18
3 months ago
GNPX...76...Added on News...🥳...https://www.prnewswire.com/news-releases/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-302358445.html
georgie18
Member Level
Re: georgie18 post# 4032
Monday, December 16, 2024 9:31:30 AM
Post#
4034
of 4037
GNPX...$1.26...🥳...AUSTIN, Texas , Dec. 16, 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 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). In addition, the Safety Review Committee (SRC) has approved the opening of the Phase 2 expansion portion of the trial.
The combination of REQORSA and atezolizumab previously received U.S. Food and Drug Administration's (FDA) Fast Track Designation for the treatment of the Acclaim-3 patient population, and the FDA has also granted Orphan Drug Designation to REQORSA for the treatment of 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.
georgie18
4 months ago
GNPX...$1.26...🥳...AUSTIN, Texas , Dec. 16, 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 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). In addition, the Safety Review Committee (SRC) has approved the opening of the Phase 2 expansion portion of the trial.
The combination of REQORSA and atezolizumab previously received U.S. Food and Drug Administration's (FDA) Fast Track Designation for the treatment of the Acclaim-3 patient population, and the FDA has also granted Orphan Drug Designation to REQORSA for the treatment of 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.
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