Genprex Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators
- Expansion of nonclinical programs into new indications through Sponsored Research Agreements and Material Transfer Agreements
- Study of TUSC2 and NPRL2 in ALK-positive lung cancer and other undisclosed programs
- Presentation of Genprex's ONCOPREX® Nanoparticle Delivery System technology at the 2024 AACR Annual Meeting
- No negative aspects identified in the press release
Insights
The exploration of REQORSA therapy for ALK-positive lung cancer represents a significant stride in oncology, particularly in the subset of non-small cell lung cancer (NSCLC) that harbors the ALK-EML4 translocation. This genetic alteration is present in a small percentage of NSCLCs but has a profound impact on the patient population, which tends to be younger and healthier. The current 5-year survival rate, while higher than other lung cancers, still indicates a substantial need for improved treatments. The potential of REQORSA, which leverages the TUSC2 tumor suppressor gene, could offer a new avenue for therapy, especially given the inevitable development of resistance to existing ALK inhibitors.
From a clinical perspective, the combination of REQORSA with ALK inhibitors could represent an innovative approach to overcome resistance mechanisms. The ability of REQORSA to potentially restore the function of a tumor suppressor gene could also synergize with other treatments to induce a more robust anti-cancer effect. This research is pivotal as it may lead to new therapeutic protocols that could extend survival and improve the quality of life for patients with this specific type of lung cancer.
The acceptance of Genprex's abstracts for presentation at the AACR Annual Meeting underscores the scientific community's interest in their nonclinical findings. The focus on TUSC2 and its role in mitochondrial metabolism adds another layer of complexity to our understanding of cancer biology. The link between TUSC2 and metabolic pathways could have far-reaching implications, potentially influencing how we approach cancer treatment from a metabolic standpoint. Furthermore, the investigation into NPRL2 and its delivery via Genprex's ONCOPREX Nanoparticle Delivery System could validate the platform's versatility and applicability to a range of tumor suppressor genes.
The nonclinical expansion into new indications, such as ALK-positive lung cancer, could pave the way for REQORSA's inclusion in future clinical trials. This progression from nonclinical to clinical stages is a critical step in drug development and positive data could significantly impact Genprex's valuation and attractiveness to investors. It is crucial to monitor the outcomes of these studies as they may lead to breakthroughs that could disrupt current treatment paradigms and create new market opportunities.
Genprex's announcement of expanding nonclinical programs and the subsequent presentation at a prestigious scientific meeting could have material implications for the company's stock performance. The focus on ALK-positive lung cancer, a market with a clear unmet need, could position Genprex favorably in the eyes of investors. The potential of REQORSA to address resistance issues in ALK-EML4 translocated lung cancer could open up a significant market opportunity and positive outcomes from these studies could lead to an increase in market valuation.
Investors should consider the long-term research and development timelines inherent in biotechnology, as well as the risks associated with clinical trials. However, the strategic expansion into additional programs and the use of a non-viral delivery system may diversify the company's portfolio and reduce risk. It is also essential to analyze Genprex's financial health, capital burn rate and funding strategies to sustain these research initiatives. The company's ability to progress from nonclinical to clinical stages without diluting shareholder value will be a key factor in assessing its investment potential.
Reqorsa® Therapy May Be Potential Treatment for ALK-Positive Lung Cancer
Three Collaborators Selected to Present Positive Nonclinical Data on Genprex Oncology Program at the 2024 American Association for Cancer Research (AACR) Annual Meeting
"We are developing a robust research program to expand the potential tumor targets, and even non-tumor targets, that we may include in future clinical trials for REQORSA," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "Research indicates that the TUSC2 gene used in REQORSA may benefit many types of cancers and potentially the treatment of other diseases. We are exploring opportunities to treat other cancers in which TUSC2 is often deleted or inactivated, and we are evaluating TUSC2 basic biology to better understand how to use our REQORSA treatment. Finally, we are also exploring the use of another tumor suppressor gene, NPRL2, in cancer treatment using our Oncoprex® Nanoparticle Delivery System."
Genprex's expanded nonclinical programs include these additional studies with TUSC2 and NPRL2:
- TUSC2 in ALK-EML4 positive translocated lung cancer at the University of Michigan Rogel Cancer Center
- TUSC2 in metabolism at Meharry Medical College in
Nashville, Tennessee - NPRL2 in lung cancers with a major cancer research center in
Houston, Texas
TUSC2 in ALK-EML4 positive translocated lung cancer at the University of Michigan Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative:
ALK-EML4 positive translocated lung cancer is a subset of non-small cell lung cancer (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
TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer. In fact, approximately
TUSC2 Control of Mitochondrial Metabolism at Meharry Medical College:
The TUSC2 gene is encoded in the cell's DNA in the nucleus, but the TUSC2 protein resides in the inner membrane of the mitochondria. This suggests that TUSC2 protein may be one way in which the cell controls energy production, which largely occurs in the inner membrane of the mitochondria. In addition, mice lacking the TUSC2 gene in all cells, or TUSC2 knock-out mice, can exhibit a number of characteristics consistent with underlying metabolic abnormalities, including premature aging, aging-associated pathologies, and decreased survival. Thus, researchers at Meharry Medical College have been exploring TUSC2 effects on mitochondrial metabolism and have had their work accepted for presentation at the 2024 AACR Annual Meeting.
NPRL2 in Lung Cancers
Following a presentation on NPRL2 at AACR 2023, additional research has been performed to evaluate the use of lipid nanoparticles containing the tumor suppressor gene, NPRL2, in mouse xenografts with resistant cancers. This work, which validates Genprex's ONCOPREX Nanoparticle Delivery System technology as a platform, has been selected for a presentation at the 2024 AACR Annual Meeting.
Genprex's ONCOPREX® Nanoparticle Delivery System, is a novel non-viral approach that utilizes lipid nanoparticles to deliver tumor suppressor genes deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of toxicity often associated with viral delivery systems. Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.
About Reqorsa® Therapy
REQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex's ONCOPREX® Nanoparticle 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® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. 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® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three 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-003 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, 2022.
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; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; 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
What are Genprex's nonclinical programs expanding into?
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