Genprex Announces Sponsored Research Agreement with The University of Michigan Rogel Cancer Center and Lung Cancer Study Collaboration with ALK Positive
Genprex (NASDAQ: GNPX) has entered into a Sponsored Research Agreement with the University of Michigan Rogel Cancer Center to study TUSC2 combined with ALK-inhibitors in ALK-EML4 positive lung cancer. The company also announced a collaboration with ALK Positive, a non-profit patient research organization. Preclinical data presented at AACR 2024 showed REQORSA induced apoptosis in alectinib resistant EML4-ALK positive NSCLC cell lines. The research targets ALK+ lung cancer, found in approximately 5% of NSCLCs, where about 82% have decreased TUSC2 tumor suppressor protein. While current ALK-targeted therapies show initial benefits, resistance develops over time, with a 5-year survival rate of 40.9%.
Genprex (NASDAQ: GNPX) ha stipulato un Accordo di Ricerca Sponsorizzata con il Rogel Cancer Center dell'Università del Michigan per studiare TUSC2 in combinazione con inibitori ALK nel cancro ai polmoni positivo per ALK-EML4. L'azienda ha anche annunciato una collaborazione con ALK Positive, un'organizzazione no-profit di ricerca sui pazienti. I dati preclinici presentati all'AACR 2024 hanno mostrato che REQORSA ha indotto apoptosi in linee cellulari NSCLC positive per EML4-ALK resistenti all'alectinib. La ricerca si concentra sul cancro ai polmoni ALK+, presente in circa il 5% degli NSCLC, dove circa l'82% ha una diminuzione della proteina soppressore tumorale TUSC2. Anche se le attuali terapie mirate contro ALK mostrano benefici iniziali, la resistenza si sviluppa nel tempo, con un tasso di sopravvivenza a 5 anni del 40.9%.
Genprex (NASDAQ: GNPX) ha firmado un Acuerdo de Investigación Patrocinada con el Rogel Cancer Center de la Universidad de Michigan para estudiar TUSC2 combinado con inhibidores de ALK en cáncer de pulmón positivo para ALK-EML4. La compañía también anunció una colaboración con ALK Positive, una organización de investigación para pacientes sin ánimo de lucro. Los datos preclínicos presentados en la AACR 2024 mostraron que REQORSA indujo apoptosis en líneas celulares NSCLC positivas para EML4-ALK resistentes a alectinib. La investigación se centra en el cáncer de pulmón ALK+, que se encuentra en aproximadamente el 5% de los NSCLC, donde aproximadamente el 82% tiene disminuida la proteína supresora tumoral TUSC2. Si bien las terapias dirigidas actuales a ALK muestran beneficios iniciales, la resistencia se desarrolla con el tiempo, con una tasa de supervivencia a 5 años del 40.9%.
Genprex (NASDAQ: GNPX)는 미시간 대학교 로겔 암 센터와 ALK-EML4 양성 폐암에서 ALK 억제제와 함께 TUSC2를 연구하기 위한 후원 연구 협정에 들어갔습니다. 회사는 또한 비영리 환자 연구 기관인 ALK Positive와의 협력을 발표했습니다. 2024년 AACR에서 발표된 전임상 데이터는 REQORSA가 알렉틴비에 저항성인 EML4-ALK 양성 NSCLC 세포주에서 세포 사멸을 유도했음을 보여주었습니다. 연구는 NSCLC의 약 5%에 있는 ALK+ 폐암을 대상으로 하며, 이들 중 약 82%는 TUSC2 종양 억제 단백질이 감소했습니다. 현재 ALK 타겟 요법이 초기 이점을 보이지만, 시간이 지남에 따라 저항성이 발생하며 5년 생존율은 40.9%입니다.
Genprex (NASDAQ: GNPX) a conclu un accord de recherche sponsorisé avec le Rogel Cancer Center de l'Université du Michigan pour étudier TUSC2 associé aux inhibiteurs ALK dans le cancer du poumon positif pour ALK-EML4. L'entreprise a également annoncé une collaboration avec ALK Positive, une organisation de recherche sur les patients à but non lucratif. Les données précliniques présentées à l'AACR 2024 ont montré que REQORSA induisait l'apoptose dans des lignées cellulaires NSCLC positives pour EML4-ALK résistantes à l'alectinib. La recherche cible le cancer du poumon ALK+, qui se trouve dans environ 5 % des NSCLC, où environ 82 % ont une diminution de la protéine suppresseur tumorale TUSC2. Bien que les thérapies actuelles ciblant ALK montrent des avantages initiaux, la résistance se développe avec le temps, avec un taux de survie à 5 ans de 40,9 %.
Genprex (NASDAQ: GNPX) hat eine geförderte Forschungsvereinbarung mit dem Rogel Cancer Center der Universität Michigan unterzeichnet, um TUSC2 in Kombination mit ALK-Inhibitoren bei ALK-EML4-positivem Lungenkrebs zu untersuchen. Das Unternehmen gab auch eine Zusammenarbeit mit ALK Positive, einer gemeinnützigen Patientenforschungseinrichtung, bekannt. Die auf der AACR 2024 präsentierten präklinischen Daten zeigten, dass REQORSA Apoptose in EML4-ALK-positiven NSCLC-Zelllinien induzierte, die gegen Alectinib resistent sind. Die Forschung zielt auf ALK+ Lungenkrebs, der bei etwa 5% der NSCLCs vorkommt, wobei etwa 82% eine verringerte TUSC2-tumorsuppressor-Proteinexpression aufweisen. Während die gegenwärtigen ALK-gerichteten Therapien anfängliche Vorteile zeigen, entwickelt sich im Laufe der Zeit eine Resistenz, mit einer 5-Jahres-Überlebensrate von 40,9 %.
- Preclinical data shows REQORSA's effectiveness in resistant lung cancer cell lines
- Partnership with University of Michigan Rogel Cancer Center expands research capabilities
- Cost-sharing agreement with ALK Positive reduces research expenses
- None.
Insights
This research collaboration represents a strategic expansion into the ALK-positive NSCLC market, targeting approximately
The mechanism of action, involving TUSC2 restoration in cancer cells where it's typically deleted (affecting
While still in early stages, this research could address an unmet medical need in ALK+ NSCLC patients who develop resistance to current therapies, potentially improving upon the current
This development expands GNPX's market potential by targeting a specific, well-defined patient population with high unmet needs. The ALK+ NSCLC market is valuable despite its relatively small patient population, as these targeted therapies typically command premium pricing. The collaboration with a patient advocacy group (ALK Positive) is strategically valuable for future patient recruitment and market access.
The shared cost structure of the research agreement demonstrates efficient capital allocation, particularly important given the company's small market cap of
Research to Study TUSC2 Combined with ALK-Inhibitors
Collaboration with Non-Profit Patient-Focused Research Group Expands Potential Lung Cancer Patient Population
for Reqorsa® Gene Therapy
The Company also announced its collaboration with ALK Positive, a non-profit patient-driven research organization dedicated to improving the life expectancy and quality of life for ALK-positive (ALK+) lung cancer patients. As a part of this collaboration, both Genprex and ALK Positive will share the cost of the SRA with the University of Michigan Rogel Cancer Center.
"We are excited to collaborate with the University of Michigan Rogel Cancer Center and ALK Positive, a group that is dedicated to helping patients with this specific subset of lung cancer, to further study how REQORSA in combination with ALK-inhibitors may be a potential therapeutic treatment for ALK+ lung cancer," said Ryan Confer, President and Chief Executive Officer at Genprex. "TUSC2 is often deleted or inactivated in certain types of cancer. Our preclinical data in cell lines with ALK translocations indicate that REQORSA may be effective in combination with ALK inhibitors, and the work in this SRA will build on our earlier studies."
As the Company further expands its research program to new tumor targets, 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
Research collaborators at the Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative presented positive preclinical data at the April 2024 American Association for Cancer Research (AACR) Annual Meeting, reporting that REQORSA induced apoptosis in alectinib resistant EML4-ALK positive NSCLC cell lines. Alectinib is an ALK-inhibitor commonly used to treat patients with ALK rearrangements such as EML4-ALK positive NSCLCs. Researchers found that overexpressing TUSC2 using REQORSA treatment in ALK+ lung cancer cell lines inhibited the ability of the cells to form colonies. Ultimately, 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 alectinib. To review the poster presented at the April 2024 AACR Annual meeting, visit Genprex's website.
ALK+ lung cancer is a subset of NSCLC that impacts young and relatively healthy individuals. Since the discovery of the ALK-EML4 translocation, there has been research into targeting and treating this malignancy, which has led to approval by the
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, such as the ALK pathway, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, decreases cancer cell energy production by decreasing glycolysis, 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.
(877) 774-GNPX (4679)
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