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

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Genprex (NASDAQ: GNPX) announced that its research collaborators will present positive preclinical data for GPX-002, their diabetes gene therapy drug candidate, at the 2025 American Diabetes Association 85th Scientific Sessions in Chicago.

GPX-002 is being developed as a potential disease-modifying therapy for both Type 1 and Type 2 diabetes, aiming to eliminate the need for daily blood glucose monitoring and insulin replacement therapy. Recent company developments include:

  • Signing an amended license agreement for multiple diabetes gene therapy technologies
  • Formation of Convergen Biotech subsidiary focused on diabetes program development
  • Addition of research on re-dosable non-viral delivery systems

Two presentations are scheduled: a poster presentation on lipid nanoparticles for islet cell transfection, and an oral presentation on AAV-mediated gene therapy treatment in non-human primates with streptozotocin-induced diabetes.

Genprex (NASDAQ: GNPX) ha annunciato che i suoi collaboratori di ricerca presenteranno dati preclinici positivi per GPX-002, il loro candidato farmaco per la terapia genica del diabete, durante la 85a Sessione Scientifica dell'American Diabetes Association nel 2025 a Chicago.

GPX-002 è in fase di sviluppo come potenziale terapia modificante la malattia per il diabete di tipo 1 e tipo 2, con l'obiettivo di eliminare la necessità di monitoraggio giornaliero della glicemia e della terapia sostitutiva con insulina. Gli sviluppi recenti dell'azienda includono:

  • Firma di un accordo di licenza modificato per diverse tecnologie di terapia genica per il diabete
  • Formazione di una filiale, Convergen Biotech, focalizzata sullo sviluppo di programmi per il diabete
  • Aggiunta di ricerche su sistemi di somministrazione non virali ripetibili

Due presentazioni sono programmate: una presentazione poster sulle nanoparticelle lipidiche per la trasfezione delle cellule isletiche e una presentazione orale sul trattamento con terapia genica mediata da AAV in primati non umani con diabete indotto da streptozotocina.

Genprex (NASDAQ: GNPX) anunció que sus colaboradores de investigación presentarán datos preclínicos positivos para GPX-002, su candidato a fármaco de terapia génica para la diabetes, en la 85ª Sesión Científica de la Asociación Americana de Diabetes en 2025 en Chicago.

GPX-002 se está desarrollando como una posible terapia modificadora de la enfermedad para diabetes tipo 1 y tipo 2, con el objetivo de eliminar la necesidad de monitoreo diario de la glucosa en sangre y terapia de reemplazo de insulina. Los desarrollos recientes de la empresa incluyen:

  • Firma de un acuerdo de licencia modificado para múltiples tecnologías de terapia génica para la diabetes
  • Formación de la subsidiaria Convergen Biotech centrada en el desarrollo de programas para la diabetes
  • Adición de investigaciones sobre sistemas de entrega no virales reutilizables

Están programadas dos presentaciones: una presentación en cartel sobre nanopartículas lipídicas para la transfección de células de islote y una presentación oral sobre el tratamiento de terapia génica mediada por AAV en primates no humanos con diabetes inducida por estreptozotocina.

Genprex (NASDAQ: GNPX)는 연구 협력자들이 2025년 시카고에서 열리는 미국당뇨병학회 제85회 과학 세션에서 당뇨병 유전자 치료 후보 물질인 GPX-002에 대한 긍정적인 전임상 데이터를 발표할 것이라고 발표했습니다.

GPX-002는 제1형 및 제2형 당뇨병을 위한 잠재적인 질병 수정 치료제로 개발되고 있으며, 매일 혈당 모니터링과 인슐린 대체 치료의 필요성을 없애는 것을 목표로 하고 있습니다. 회사의 최근 개발 사항은 다음과 같습니다:

  • 여러 당뇨병 유전자 치료 기술에 대한 수정된 라이센스 계약 체결
  • 당뇨병 프로그램 개발에 집중하는 Convergen Biotech 자회사 설립
  • 재사용 가능한 비바이러스 전달 시스템에 대한 연구 추가

두 개의 발표가 예정되어 있습니다: 이자 셀 전이(transfection)를 위한 지질 나노입자에 대한 포스터 발표와 스트렙토조토신으로 유도된 당뇨병을 가진 비인간 영장류에 대한 AAV 매개 유전자 치료에 대한 구두 발표입니다.

Genprex (NASDAQ: GNPX) a annoncé que ses collaborateurs de recherche présenteront des données précliniques positives pour GPX-002, leur candidat médicament pour la thérapie génique du diabète, lors de la 85e Session Scientifique de l'American Diabetes Association en 2025 à Chicago.

GPX-002 est en cours de développement en tant que thérapie potentiellement modifiant la maladie pour le diabète de type 1 et de type 2, visant à éliminer la nécessité d'une surveillance quotidienne de la glycémie et d'une thérapie de remplacement à l'insuline. Les développements récents de l'entreprise incluent :

  • Signature d'un accord de licence modifié pour plusieurs technologies de thérapie génique pour le diabète
  • Création de la filiale Convergen Biotech axée sur le développement de programmes pour le diabète
  • Ajout de recherches sur des systèmes de livraison non viraux réutilisables

Deux présentations sont prévues : une présentation par affiche sur les nanoparticules lipidiques pour la transfection des cellules îlot et une présentation orale sur le traitement par thérapie génique médiée par AAV chez des primates non humains atteints de diabète induit par la streptozotocine.

Genprex (NASDAQ: GNPX) gab bekannt, dass seine Forschungspartner positive präklinische Daten zu GPX-002, ihrem Kandidaten für die Gentherapie bei Diabetes, auf der 85. Wissenschaftlichen Sitzung der American Diabetes Association im Jahr 2025 in Chicago präsentieren werden.

GPX-002 wird als potenzielle krankheitsmodifizierende Therapie für Typ-1- und Typ-2-Diabetes entwickelt, mit dem Ziel, die Notwendigkeit täglicher Blutzuckerüberwachung und Insulinersatztherapie zu beseitigen. Zu den jüngsten Entwicklungen des Unternehmens gehören:

  • Unterzeichnung eines geänderten Lizenzvertrags für mehrere Technologien zur Gentherapie bei Diabetes
  • Gründung der Tochtergesellschaft Convergen Biotech, die sich auf die Entwicklung von Diabetesprogrammen konzentriert
  • Ergänzung von Forschungen zu wiederverwendbaren nicht-viralen Abgabesystemen

Zwei Präsentationen sind geplant: eine Posterpräsentation zu Lipidnanopartikeln für die Transfektion von Inselzellen und eine mündliche Präsentation zur AAV-vermittelten Gentherapie bei nichtmenschlichen Primaten mit streptozotocin-induziertem Diabetes.

Positive
  • Development of potentially revolutionary gene therapy for both Type 1 and Type 2 diabetes
  • Secured expanded license agreement for multiple diabetes gene therapy technologies
  • Created dedicated subsidiary (Convergen Biotech) for diabetes program development
  • Research advancement into re-dosable non-viral delivery systems
Negative
  • Still in preclinical stage, indicating long pathway to potential commercialization

Insights

Genprex's announcement represents incremental positive momentum for their diabetes gene therapy program, though still at the preclinical stage. The selection to present at the American Diabetes Association's Scientific Sessions provides validation from the scientific community for their GPX-002 candidate, which is significant for a company with a $3.1 million market cap.

The preclinical data presentation will showcase two important aspects of their program: lipid nanoparticle selection for islet cell transfection and AAV-mediated gene therapy results in non-human primates. These are crucial technical milestones that could address fundamental delivery challenges in gene therapy.

The company has made strategic moves to advance this program, including restructuring their license agreement for diabetes gene therapies, forming a dedicated subsidiary (Convergen Biotech), and exploring non-viral delivery systems that might enable re-dosing - a significant limitation of current gene therapies.

While the positive preclinical data suggests progress, investors should recognize that GPX-002 remains years away from potential commercialization, with numerous clinical and regulatory hurdles ahead. The diabetes therapeutic landscape is highly competitive, but gene therapies offering disease modification and freedom from daily insulin therapy could represent a paradigm shift if successful in later-stage trials.

The presentation of GPX-002 preclinical data at the ADA Scientific Sessions represents an interesting development in diabetes therapeutic research. Current diabetes management requires lifelong insulin therapy or medication with constant glucose monitoring, creating substantial patient burden.

The non-human primate results using AAV-mediated gene therapy in streptozotocin-induced diabetes models are particularly noteworthy, as this represents a closer approximation to human physiology than rodent models. Streptozotocin destroys pancreatic beta cells to simulate Type 1 diabetes, so positive results suggest potential beta cell regeneration or preservation capabilities.

The lipid nanoparticle transfection research indicates Genprex is exploring multiple delivery mechanisms beyond viral vectors, which could address dosing limitations in current gene therapies. Islets of Langerhans targeting is challenging but essential for effective diabetes gene therapy.

If successful in future clinical trials, a therapy that eliminates daily monitoring and insulin injections would significantly improve quality of life for diabetes patients. However, caution is warranted as many promising preclinical diabetes treatments have failed to translate to humans. The dual approach to both Type 1 and Type 2 diabetes is ambitious but would dramatically expand the potential patient population if effective across both conditions.

Novel Gene Therapy Program is Addressing Type 1 and Type 2 Diabetes

AUSTIN, Texas, March 25, 2025 /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 its research collaborators have been selected to present at the upcoming 2025 American Diabetes Association (ADA) 85th Scientific Session being held June 20-23, 2025 in Chicago, Illinois. The collaborators will present positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate.

"We are thrilled that our collaborators have been selected to present positive preclinical data and new research on our novel gene therapy for diabetes at the largest worldwide scientific meeting for clinicians and researchers in diabetes," said Ryan Confer, President and Chief Executive Officer at Genprex. "We are proud that our diabetes program has been recognized by an organization committed to the latest cutting-edge advances in diabetes. We are dedicated to advancing our diabetes program, and we believe GPX-002 has the potential to be a game-changer in emerging diabetes therapies."

GPX-002 holds the potential for disease modification for long-term effectiveness, potentially replacing the daily burden of blood glucose monitoring and insulin replacement therapy. Genprex recently provided an update on its diabetes gene therapy program, including the signing of an amended and restated license agreement for multiple technologies for gene therapy for Type 1 and Type 2 diabetes; the formation of a wholly-owned subsidiary, Convergen Biotech, to focus on diabetes program development; and the addition of research focused on using a potentially re-dosable non-viral delivery system.

The featured Genprex-supported abstracts to be presented at the 85th Scientific Sessions include:

Title: Selecting Lipid Nanoparticles for Transfection of Islets of Langerhans Cells
Type: Poster Presentation
Category: 20 Beta-Cell Replacement
Poster Number: 1567-B
Presentation Date: Saturday, June 21, 2025
Presentation Time: 12:30 – 1:30 p.m. CT
Presenter: József Répási, AldexChem LTD

Title: Recombinant AAV-mediated Gene Therapy For The Treatment Of Streptozotocin-Induced Diabetes in Non-Human Primates
Type: Oral Presentation
Track: Immunology/Beta-Cell Replacement
Category: Exploring Alternative Strategies to Stem Cell-Dervied Beta Cells and Insights from Autologous Islet Transplantation
Presentation Date: Monday, June 23, 2025
Presentation Time: 1:30 p.m. CT
Presenter: Hannah Rinehardt, MD, University of Pittsburgh Medical Center

About GPX-002
GPX-002, which has been exclusively licensed from the University of Pittsburgh, is currently being developed using the same construct for the treatment of both Type 1 diabetes (T1D) and Type 2 diabetes (T2D). The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) 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. 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 vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time in T1D mouse models. In T2D, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

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 for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2023.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals, including, but not limited to, the Company's diabetes clinical development program and the Company's beliefs about the anticipated effects of GPX-002 and its potential as a therapeutic approach; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

GNPX Investor Relations
investors@genprex.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/genprex-collaborators-selected-to-present-positive-preclinical-data-on-diabetes-gene-therapy-at-the-2025-american-diabetes-association-85th-scientific-sessions-302410302.html

SOURCE Genprex, Inc.

FAQ

What is GPX-002 and how could it revolutionize diabetes treatment?

GPX-002 is Genprex's gene therapy candidate designed to potentially modify both Type 1 and Type 2 diabetes, aiming to eliminate daily blood glucose monitoring and insulin therapy needs.

What are the key presentations for GNPX's diabetes therapy at ADA 2025?

Two presentations: a poster on lipid nanoparticles for islet cell transfection and an oral presentation on AAV-mediated gene therapy in non-human primates with diabetes.

How is Genprex (GNPX) advancing its diabetes program development?

Through a new license agreement for multiple technologies, forming Convergen Biotech subsidiary, and researching re-dosable non-viral delivery systems.

When and where will GNPX's diabetes therapy data be presented?

At the American Diabetes Association 85th Scientific Sessions in Chicago, June 20-23, 2025.
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