Genprex Signs Exclusive License to Additional Gene Therapy Technologies with the University of Michigan for the Treatment of Lung Cancer
Genprex (NASDAQ: GNPX) has secured a worldwide exclusive license from the University of Michigan for patent rights relating to Reqorsa® Gene Therapy in combination with ALK-inhibitors for treating ALK-EML4 positive lung cancer. Preclinical data showed that Reqorsa induced apoptosis in alectinib resistant EML4-ALK positive non-small cell lung cancer cells. The research indicates that TUSC2, a tumor suppressor gene frequently deleted in lung cancer, when overexpressed in ALK+ NSCLC cell lines, effectively decreased cell growth through activation of apoptotic pathways.
Genprex (NASDAQ: GNPX) ha ottenuto una licenza esclusiva mondiale dalla University of Michigan per i diritti di brevetto relativi alla terapia genica Reqorsa® in combinazione con inibitori ALK per il trattamento del cancro ai polmoni positivo per ALK-EML4. I dati preclinici hanno mostrato che Reqorsa ha indotto l'apoptosi nelle cellule di carcinoma polmonare non a piccole cellule positive per EML4-ALK resistenti ad alectinib. La ricerca indica che TUSC2, un gene oncosoppressore frequentemente delezionato nel cancro ai polmoni, quando sovraespresso nelle linee cellulari ALK+ NSCLC, ha ridotto efficacemente la crescita cellulare attraverso l'attivazione di vie apoptotiche.
Genprex (NASDAQ: GNPX) ha conseguido una licencia exclusiva mundial de la Universidad de Michigan para los derechos de patente relacionados con la terapia génica Reqorsa® en combinación con inhibidores de ALK para tratar el cáncer de pulmón positivo para ALK-EML4. Los datos preclínicos mostraron que Reqorsa indujo apoptosis en células de cáncer de pulmón no microcítico positivas para EML4-ALK resistentes a alectinib. La investigación indica que TUSC2, un gen supresor de tumores frecuentemente eliminado en el cáncer de pulmón, cuando se sobreexpresa en líneas celulares ALK+ NSCLC, disminuye efectivamente el crecimiento celular a través de la activación de vías apoptóticas.
Genprex (NASDAQ: GNPX)는 미시간 대학교로부터 ALK 억제제와 결합된 Reqorsa® 유전자 치료에 관한 특허권에 대한 전 세계 독점 라이센스를 확보했습니다. 전임상 데이터는 Reqorsa가 alectinib에 저항성이 있는 EML4-ALK 양성 비소세포 폐암 세포에서 세포 사멸을 유도했음을 보여주었습니다. 연구는 폐암에서 자주 삭제되는 종양 억제 유전자 TUSC2가 ALK+ NSCLC 세포주에서 과발현될 때, 세포 성장 감소를 효과적으로 이끌어내며 세포 사멸 경로를 활성화한다는 것을 나타냅니다.
Genprex (NASDAQ: GNPX) a obtenu une licence exclusive mondiale de l'Université du Michigan pour les droits de brevet concernant la thérapie génique Reqorsa® en combinaison avec des inhibiteurs d'ALK pour traiter le cancer du poumon positif pour ALK-EML4. Les données précliniques ont montré que Reqorsa induisait l'apoptose dans des cellules de cancer du poumon non à petites cellules positives pour EML4-ALK résistantes à l'alectinib. La recherche indique que TUSC2, un gène suppresseur de tumeur souvent supprimé dans le cancer du poumon, lorsqu'il est surexprimé dans des lignées cellulaires ALK+ NSCLC, diminue effectivement la croissance cellulaire par l'activation de voies apoptotiques.
Genprex (NASDAQ: GNPX) hat eine weltweite exklusive Lizenz von der University of Michigan für Patentrechte in Bezug auf Reqorsa® Gentherapie in Kombination mit ALK-Inhibitoren zur Behandlung von ALK-EML4-positivem Lungenkrebs gesichert. Vorklinische Daten zeigten, dass Reqorsa Apoptose in alectinib-resistenten EML4-ALK-positiven nicht-kleinzelligen Lungenkrebszellen induzierte. Die Forschung zeigt, dass TUSC2, ein Tumorsuppressor-Gen, das häufig im Lungenkrebs gelöscht wird, bei Überexpression in ALK+ NSCLC-Zelllinien das Zellwachstum effektiv durch Aktivierung apoptotischer Wege verringerte.
- Secured worldwide exclusive license for Reqorsa® therapy patent rights
- Positive preclinical data showing effectiveness against ALK+ lung cancer
- Potential expansion into new lung cancer treatment subset (ALK+ NSCLC)
- Enhanced intellectual property portfolio protection
- None.
Insights
This exclusive licensing agreement marks a significant expansion of Genprex's therapeutic potential in lung cancer treatment. The combination of Reqorsa with ALK inhibitors addresses an important 5% subset of NSCLC patients with ALK translocations, targeting a specific market need where resistance to current treatments often develops.
The preclinical data showing REQORSA's effectiveness in alectinib-resistant cases is particularly noteworthy, as drug resistance remains a major challenge in ALK+ NSCLC treatment. With 82% of NSCLCs showing decreased TUSC2 expression, this therapy's mechanism of action through TUSC2 restoration could provide a novel approach to overcome resistance mechanisms. However, investors should note that successful preclinical results don't guarantee clinical trial success and significant development work lies ahead.
The exclusive worldwide license significantly strengthens Genprex's intellectual property position in the competitive oncology space. This strategic IP expansion protects potential revenue streams from both the technology and future drug combinations. For a small-cap company (
License includes Genprex's Reqorsa® Gene Therapy in Combination with ALK-Inhibitors for the Potential Treatment of ALK-Positive Lung Cancer
"We continue to bolster our intellectual property portfolio for REQORSA, understanding that our lead drug candidate may benefit patients with many types of cancers," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "Positive preclinical data indicate that REQORSA in combination with ALK inhibitors may provide benefit to patients with ALK-positive (ALK+) lung cancer. We are pleased to be able to protect this drug combination for a new subset of lung cancer patients, which widens our exclusivity of drug combinations with REQORSA and enhances our intellectual property position."
REQORSA in combination with ALK inhibitors could be a potential therapeutic treatment for ALK+ lung cancer. TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer. In fact, approximately
The study found that the use of REQORSA or a TUSC2-containing plasmid to overexpress TUSC2 in ALK+ NSCLC cell lines was effective in decreasing cell growth and proliferation through the activation of apoptotic pathways. Researchers believe the results of this preclinical work support further clinical study of REQORSA as an anti-ALK NSCLC treatment strategy. Genprex believes this research suggests that REQORSA may be an effective treatment in patients progressing on ALK inhibitors. To review the poster presented at the 2024 AACR Annual meeting, visit Genprex's website.
About Reqorsa® Gene Therapy
REQORSA (quaratusugene ozeplasmid) for NSCLC and small-cell lung cancer (SCLC) consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex's ONCOPREX® Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.
Genprex's strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA's unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
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: REQORSA's potential as a therapeutic treatment in combination with ALK-inhibitors for ALK-positive lung cancer; 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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FAQ
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