Genprex Signs Exclusive Technology License Agreement with New York University Langone Health for the Treatment of Mesothelioma
Genprex (NASDAQ: GNPX) has signed an exclusive patent license agreement with NYU Langone Health for Reqorsa® Gene Therapy to treat mesothelioma. The therapy shows promising preclinical results in treating Malignant Pleural Mesothelioma (MPM).
Research data presented at the 2024 EORTC-NCI-AACR Symposium demonstrated that REQORSA significantly decreased cell proliferation and invasion while increasing cell apoptosis in MPM cell lines. The therapy utilizes the TUSC2 tumor suppressor gene, which is downregulated in 84% of mesotheliomas.
Genprex formed a Mesothelioma Clinical Advisory Board in 2024 with four leading researchers to support its preclinical program. According to CDC data, mesothelioma affects approximately 3,000 new cases annually in the U.S., with a life expectancy of 18 months and a 3-year survival rate of 23% with treatment.
Genprex (NASDAQ: GNPX) ha firmato un accordo esclusivo di licenza brevettuale con NYU Langone Health per la terapia genica Reqorsa® destinata al trattamento del mesotelioma. La terapia mostra risultati preclinici promettenti nel trattamento del mesotelioma pleurico maligno (MPM).
I dati di ricerca presentati al Simposio EORTC-NCI-AACR 2024 hanno dimostrato che REQORSA riduce significativamente la proliferazione e l'invasione cellulare, aumentando al contempo l'apoptosi nelle linee cellulari MPM. La terapia sfrutta il gene oncosoppressore TUSC2, che risulta downregolato nell'84% dei mesoteliomi.
Nel 2024 Genprex ha costituito un Comitato Consultivo Clinico sul Mesotelioma con quattro ricercatori di spicco per supportare il programma preclinico. Secondo i dati CDC, il mesotelioma colpisce circa 3.000 nuovi casi ogni anno negli Stati Uniti, con una aspettativa di vita di 18 mesi e un tasso di sopravvivenza a 3 anni del 23% con trattamento.
Genprex (NASDAQ: GNPX) ha firmado un acuerdo exclusivo de licencia de patente con NYU Langone Health para la terapia génica Reqorsa® para tratar el mesotelioma. La terapia muestra resultados preclínicos prometedores en el tratamiento del mesotelioma pleural maligno (MPM).
Los datos de investigación presentados en el Simposio EORTC-NCI-AACR 2024 demostraron que REQORSA disminuyó significativamente la proliferación e invasión celular, mientras aumentaba la apoptosis en líneas celulares de MPM. La terapia utiliza el gen supresor tumoral TUSC2, que está regulado a la baja en el 84% de los mesoteliomas.
En 2024, Genprex formó un Comité Asesor Clínico de Mesotelioma con cuatro investigadores destacados para apoyar su programa preclínico. Según datos del CDC, el mesotelioma afecta aproximadamente a 3,000 casos nuevos anualmente en EE. UU., con una expectativa de vida de 18 meses y una tasa de supervivencia a 3 años del 23% con tratamiento.
Genprex (NASDAQ: GNPX)는 악성 중피종 치료를 위한 Reqorsa® 유전자 치료제에 대해 NYU Langone Health와 독점 특허 라이선스 계약을 체결했습니다. 이 치료법은 악성 흉막 중피종(MPM) 치료에서 유망한 전임상 결과를 보여주고 있습니다.
2024년 EORTC-NCI-AACR 심포지엄에서 발표된 연구 데이터에 따르면 REQORSA는 MPM 세포주에서 세포 증식과 침습을 크게 감소시키고 세포 자멸사를 증가시켰습니다. 이 치료법은 중피종의 84%에서 발현이 저하된 TUSC2 종양 억제 유전자를 활용합니다.
Genprex는 2024년에 4명의 주요 연구원과 함께 전임상 프로그램을 지원하기 위해 중피종 임상 자문 위원회를 구성했습니다. CDC 데이터에 따르면 중피종은 미국에서 매년 약 3,000건의 신규 환자가 발생하며, 치료 시 평균 생존 기간은 18개월, 3년 생존율은 23%입니다.
Genprex (NASDAQ : GNPX) a signé un accord de licence de brevet exclusif avec NYU Langone Health pour la thérapie génique Reqorsa® destinée au traitement du mésothéliome. Cette thérapie présente des résultats précliniques prometteurs dans le traitement du mésothéliome pleural malin (MPM).
Les données de recherche présentées lors du symposium EORTC-NCI-AACR 2024 ont montré que REQORSA réduisait significativement la prolifération et l'invasion cellulaires tout en augmentant l'apoptose dans les lignées cellulaires de MPM. La thérapie utilise le gène suppresseur de tumeur TUSC2, qui est sous-exprimé dans 84 % des mésothéliomes.
En 2024, Genprex a constitué un comité consultatif clinique sur le mésothéliome avec quatre chercheurs de premier plan pour soutenir son programme préclinique. Selon les données du CDC, le mésothéliome touche environ 3 000 nouveaux cas chaque année aux États-Unis, avec une espérance de vie de 18 mois et un taux de survie à 3 ans de 23 % avec traitement.
Genprex (NASDAQ: GNPX) hat eine exklusive Patentlizenzvereinbarung mit NYU Langone Health für die Reqorsa® Gentherapie zur Behandlung von Mesotheliom unterzeichnet. Die Therapie zeigt vielversprechende präklinische Ergebnisse bei der Behandlung des malignen Pleuramesothelioms (MPM).
Forschungsdaten, die auf dem EORTC-NCI-AACR-Symposium 2024 vorgestellt wurden, zeigten, dass REQORSA die Zellproliferation und Invasion in MPM-Zelllinien signifikant verringerte und gleichzeitig die Apoptose erhöhte. Die Therapie nutzt das Tumorsuppressorgen TUSC2, das bei 84 % der Mesotheliome herunterreguliert ist.
Genprex gründete 2024 ein klinisches Beratungsgremium für Mesotheliom mit vier führenden Forschern zur Unterstützung seines präklinischen Programms. Laut CDC-Daten erkranken in den USA jährlich etwa 3.000 Menschen an Mesotheliom, mit einer Lebenserwartung von 18 Monaten und einer 3-Jahres-Überlebensrate von 23 % bei Behandlung.
- Secured exclusive patent license for REQORSA gene therapy
- Preclinical data shows significant efficacy in reducing cancer cell proliferation and invasion
- TUSC2 gene target present in 84% of mesothelioma cases
- Established specialized Mesothelioma Clinical Advisory Board with leading experts
- Still in preclinical stage, requiring significant time and resources for clinical trials
- Targeting a relatively small patient population (3,000 new cases annually in US)
Insights
Genprex secures exclusive license for REQORSA in mesothelioma, backed by promising preclinical data showing tumor suppression potential in this high-mortality cancer.
The licensing agreement between Genprex and NYU Langone Health represents a strategic expansion of Genprex's intellectual property portfolio for Reqorsa Gene Therapy (quaratusugene ozeplasmid). From a scientific perspective, the mechanism is particularly compelling - Reqorsa delivers the TUSC2 tumor suppressor gene, which the article notes is downregulated in 84% of mesotheliomas, providing a strong biological rationale.
The preclinical data is encouraging, with researchers demonstrating that Reqorsa treatment resulted in significant decreases in cell proliferation and invasion, alongside increased cell apoptosis (programmed cell death) across all four tested MPM cell lines. These are precisely the cellular effects we look for in potential anti-cancer therapies at the preclinical stage.
Mesothelioma represents a significant unmet medical need. The article notes the dismal prognosis: 18-month life expectancy and only a 23% three-year survival rate with current treatments. With approximately 3,000 new cases annually in the U.S. and 2,500 deaths each year, there's clearly a need for novel therapeutic approaches.
The formation of Genprex's Mesothelioma Clinical Advisory Board, comprising "four world-renown researchers from major research institutions," demonstrates the company is assembling specialized expertise to guide this program's development. This is a sensible strategic step for navigating the complexities of researching a rare but deadly cancer.
While these preclinical results are promising, it's important to recognize this program remains in early development stages. The exclusive patent license does, however, provide Genprex with important intellectual property protection should they advance this therapy toward clinical trials.
Exclusive patent license strengthens Genprex's oncology IP portfolio and diversifies potential applications for their lead technology, though significant development work remains.
This exclusive patent license agreement significantly strengthens Genprex's intellectual property position for Reqorsa in mesothelioma. For biotechnology companies, particularly those focused on gene therapies, securing exclusive patent protection is fundamentally important for establishing commercial potential and protecting market opportunities.
What makes this agreement particularly valuable is that it builds upon Genprex's existing gene therapy platform (Reqorsa) by expanding its potential applications into mesothelioma. This approach of exploring multiple indications for a core technology is a capital-efficient development strategy employed by many successful biotechnology companies. Rather than developing entirely new therapeutic candidates, companies can leverage existing safety data and manufacturing processes when expanding to new indications.
The license specifically provides Genprex with "patent exclusivity" for a co-owned patent, which creates a clearer path to commercialization should the therapy demonstrate efficacy in future clinical studies. Thomas Gallagher, Genprex's Senior VP of Intellectual Property and Licensing, emphasized this agreement "positions Genprex to expand its clinical development pipeline with future clinical studies."
For rare diseases like mesothelioma, with approximately 3,000 new cases annually in the U.S., the commercial market is smaller than for common cancers. However, such indications often face less competition and may benefit from accelerated regulatory pathways, though the article doesn't mention whether Reqorsa has received any special regulatory designations for mesothelioma.
The establishment of a specialized Mesothelioma Clinical Advisory Board indicates Genprex is making a dedicated strategic investment in this program, assembling the expertise necessary to navigate the scientific and clinical challenges specific to this difficult-to-treat cancer.
Additional Gene Therapy Technology Expands Genprex's Portfolio of Oncology Licenses
"We are pleased to expand our robust oncology franchise, intellectual property portfolio and research program for REQORSA to continue exploring how it may serve as a therapeutic treatment for some of the most difficult to treat cancers and diseases," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. "We believe REQORSA has the potential to treat mesothelioma, and this license agreement positions Genprex to expand its clinical development pipeline with future clinical studies that are within the scope of the licensed patent."
Expression of TUSC2 is downregulated in
In this study, four Malignant Pleural Mesothelioma (MPM) cell lines and tert-transformed mesothelial LP9 cells were treated with REQORSA and control liposomes for 48h. Treated cells were then evaluated for TUSC2 expression by semi quantitative RT-PCR, Western blot analysis, and functional assays including cell proliferation, invasion, and apoptosis.
The researchers demonstrated that REQORSA treatment resulted in a significant decrease in cell proliferation, cell invasion, and a significant increase in cell apoptosis in all four MPM cell lines. Data also demonstrated potent tumor suppressive activity of the TUSC2 gene delivered by REQORSA, and thus, its re-expression could serve as a potential therapeutic strategy for the treatment of MPM.
In 2024, Genprex announced the formation of its Mesothelioma Clinical Advisory Board to support the Company's preclinical mesothelioma oncology program. The Board is comprised of four world-renown researchers from major research institutions specializing in the treatment of mesothelioma.
According to the Centers for Disease Control and Prevention, mesothelioma is a cancer that forms in the thin tissue that lines many internal organs, called the mesothelium. The most common kind of mesothelioma forms in the tissue around the lungs, called the pleura. This is called pleural mesothelioma, which accounts for 80
About Reqorsa® Gene Therapy
REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company's Oncoprex® Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal 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, 2024.
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: REQORSA's potential as a therapeutic treatment for mesothelioma; 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, 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.
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