Genprex Provides Update on Diabetes Gene Therapy Program
Genprex (NASDAQ: GNPX) has announced significant developments in its diabetes gene therapy program. The company has signed an amended exclusive license agreement with the University of Pittsburgh, consolidating multiple technologies for Type 1 and Type 2 diabetes gene therapy. The agreement covers worldwide exclusive rights to patent applications and technologies related to gene therapy using Pdx1 and MafA transcription factors.
The company has also formed Convergen Biotech, a wholly-owned subsidiary focused on diabetes program development. Their gene therapy product, GPX-002, is designed to transform pancreatic alpha cells into functional beta-like cells for T1D treatment and rejuvenate exhausted beta cells for T2D treatment. The therapy is administered via routine endoscopy into the pancreatic duct.
Genprex plans to seek FDA guidance for preclinical studies needed for IND application by the second half of 2025. The separation of the diabetes program into Convergen Biotech aims to expedite clinical development and enable potential direct investment and strategic collaboration.
Genprex (NASDAQ: GNPX) ha annunciato sviluppi significativi nel suo programma di terapia genica per il diabete. L'azienda ha firmato un accordo di licenza esclusiva modificato con l'Università di Pittsburgh, consolidando più tecnologie per la terapia genica del diabete di Tipo 1 e Tipo 2. L'accordo copre i diritti esclusivi a livello mondiale per le domande di brevetto e le tecnologie relative alla terapia genica che utilizzano i fattori di trascrizione Pdx1 e MafA.
L'azienda ha anche costituito Convergen Biotech, una filiale interamente controllata focalizzata sullo sviluppo del programma per il diabete. Il loro prodotto di terapia genica, GPX-002, è progettato per trasformare le cellule alfa pancreatiche in cellule beta-funzionanti simili a quelle per il trattamento del T1D e per ringiovanire le cellule beta esaurite per il trattamento del T2D. La terapia viene somministrata tramite endoscopia di routine nel dotto pancreatico.
Genprex prevede di cercare indicazioni dalla FDA per gli studi preclinici necessari per la domanda IND entro la seconda metà del 2025. La separazione del programma per il diabete in Convergen Biotech mira ad accelerare lo sviluppo clinico e a consentire potenziali investimenti diretti e collaborazioni strategiche.
Genprex (NASDAQ: GNPX) ha anunciado desarrollos significativos en su programa de terapia génica para la diabetes. La empresa ha firmado un acuerdo de licencia exclusiva enmendado con la Universidad de Pittsburgh, consolidando múltiples tecnologías para la terapia génica de la diabetes Tipo 1 y Tipo 2. El acuerdo cubre los derechos exclusivos a nivel mundial sobre las solicitudes de patentes y tecnologías relacionadas con la terapia génica utilizando los factores de transcripción Pdx1 y MafA.
La empresa también ha formado Convergen Biotech, una subsidiaria de propiedad total centrada en el desarrollo del programa de diabetes. Su producto de terapia génica, GPX-002, está diseñado para transformar las células alfa pancreáticas en células beta funcionales similares para el tratamiento del T1D y rejuvenecer las células beta agotadas para el tratamiento del T2D. La terapia se administra a través de una endoscopia de rutina en el conducto pancreático.
Genprex planea buscar orientación de la FDA para los estudios preclínicos necesarios para la solicitud IND en la segunda mitad de 2025. La separación del programa de diabetes en Convergen Biotech tiene como objetivo acelerar el desarrollo clínico y permitir posibles inversiones directas y colaboraciones estratégicas.
Genprex (NASDAQ: GNPX)는 당뇨병 유전자 치료 프로그램에서 중요한 발전을 발표했습니다. 이 회사는 피츠버그 대학교와 수정된 독점 라이선스 계약을 체결하여 제1형 및 제2형 당뇨병 유전자 치료를 위한 여러 기술을 통합했습니다. 이 계약은 Pdx1 및 MafA 전사 인자를 사용하는 유전자 치료와 관련된 특허 신청 및 기술에 대한 전 세계 독점 권리를 포함합니다.
또한 이 회사는 당뇨병 프로그램 개발에 집중하는 전액 출자 자회사인 Convergen Biotech를 설립했습니다. 그들의 유전자 치료 제품인 GPX-002는 췌장 알파 세포를 기능적인 베타 유사 세포로 변환하고 제2형 당뇨병 치료를 위해 소모된 베타 세포를 재생하도록 설계되었습니다. 이 치료는 일상적인 내시경을 통해 췌장 관으로 주입됩니다.
Genprex는 2025년 하반기까지 IND 신청에 필요한 전임상 연구를 위한 FDA 지침을 요청할 계획입니다. Convergen Biotech로의 당뇨병 프로그램 분리는 임상 개발을 가속화하고 잠재적인 직접 투자 및 전략적 협력을 가능하게 하는 것을 목표로 합니다.
Genprex (NASDAQ: GNPX) a annoncé des développements significatifs dans son programme de thérapie génique pour le diabète. L'entreprise a signé un accord de licence exclusif modifié avec l'Université de Pittsburgh, consolidant plusieurs technologies pour la thérapie génique du diabète de type 1 et de type 2. L'accord couvre les droits exclusifs mondiaux sur les demandes de brevet et les technologies liées à la thérapie génique utilisant les facteurs de transcription Pdx1 et MafA.
L'entreprise a également formé Convergen Biotech, une filiale entièrement détenue axée sur le développement de programmes pour le diabète. Leur produit de thérapie génique, GPX-002, est conçu pour transformer les cellules alpha du pancréas en cellules bêta fonctionnelles similaires pour le traitement du T1D et pour rajeunir les cellules bêta épuisées pour le traitement du T2D. La thérapie est administrée par endoscopie routinière dans le canal pancréatique.
Genprex prévoit de demander des conseils à la FDA pour les études précliniques nécessaires à la demande IND d'ici la seconde moitié de 2025. La séparation du programme diabétique en Convergen Biotech vise à accélérer le développement clinique et à permettre des investissements directs et des collaborations stratégiques potentiels.
Genprex (NASDAQ: GNPX) hat bedeutende Entwicklungen in seinem Diabetes-Gentherapieprogramm bekannt gegeben. Das Unternehmen hat einen geänderten exklusiven Lizenzvertrag mit der Universität Pittsburgh unterzeichnet, der mehrere Technologien für die Gentherapie von Typ-1- und Typ-2-Diabetes konsolidiert. Der Vertrag umfasst weltweit exklusive Rechte an Patentanmeldungen und Technologien, die sich auf die Gentherapie unter Verwendung der Transkriptionsfaktoren Pdx1 und MafA beziehen.
Das Unternehmen hat auch Convergen Biotech gegründet, eine hundertprozentige Tochtergesellschaft, die sich auf die Entwicklung von Diabetesprogrammen konzentriert. Ihr Produkt zur Gentherapie, GPX-002, ist darauf ausgelegt, Pankreas-Alphazellen in funktionelle betazellähnliche Zellen zur Behandlung von T1D zu transformieren und erschöpfte Betazellen zur Behandlung von T2D zu regenerieren. Die Therapie wird routinemäßig über eine Endoskopie in den Pankreasgang verabreicht.
Genprex plant, bis zur zweiten Hälfte von 2025 die FDA-Richtlinien für die erforderlichen präklinischen Studien zur IND-Anmeldung einzuholen. Die Trennung des Diabetesprogramms in Convergen Biotech zielt darauf ab, die klinische Entwicklung zu beschleunigen und potenzielle direkte Investitionen und strategische Kooperationen zu ermöglichen.
- Secured exclusive worldwide license for comprehensive diabetes gene therapy technologies
- Formation of focused subsidiary potentially enabling direct investment and strategic collaborations
- Advanced development timeline with FDA guidance expected in H2 2025
- Technology potentially offers long-term efficacy for both T1D and T2D through single treatment
- Product still in preclinical phase with no human trial data
- IND application timeline extends to at least late 2025
Insights
The consolidation of Genprex's license agreements with the University of Pittsburgh marks a important strategic advancement in their diabetes gene therapy program. The amended agreement creates an extensive IP portfolio covering multiple gene therapy combinations using Pdx1 and MafA transcription factors, significantly strengthening their competitive position in the $50+ billion diabetes treatment market.
The formation of Convergen Biotech as a wholly-owned subsidiary represents a sophisticated strategic move that could unlock significant value. This structure typically enables: 1) Focused investment opportunities for diabetes-specific investors, 2) Clearer valuation metrics for each therapeutic program, and 3) Enhanced operational efficiency through dedicated management and resources. The separation could facilitate faster development timelines and potentially attract strategic partnerships specifically interested in diabetes therapeutics.
The GPX-002 therapy's mechanism of action is particularly innovative, offering potential advantages over current diabetes treatments:
- For Type 1 diabetes: The transformation of alpha cells into insulin-producing beta-like cells that may evade autoimmune destruction addresses a key limitation of current therapies
- For Type 2 diabetes: The ability to rejuvenate exhausted beta cells could provide a more sustainable treatment approach than current options
- The delivery method via routine endoscopy suggests a relatively straightforward implementation path
The timeline for FDA guidance on IND-enabling studies by H2 2025 indicates steady progress, though investors should note that significant development milestones remain before potential commercialization. The consolidation of IP rights and formation of a dedicated subsidiary positions Genprex to potentially accelerate development through focused resources and strategic partnerships.
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
"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
Exclusive License Agreement with the University of
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
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
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.
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, such as the Company's diabetes product candidate, GPX-002; 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 its ongoing work with Pitt; 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, including successful implementation of the separation of its diabetes clinical development program, including the anticipated benefits of the internal reorganization, the expected timing of the reorganization and/or if it is completed as contemplated or at all; 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
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SOURCE Genprex, Inc.
FAQ
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