Genprex Collaborators Report Positive Preclinical Data on the Use of Reqorsa® and on NPRL2 Gene Therapy Utilizing Non-Viral Oncoprex® Delivery System for the Treatment of Lung Cancers at the 2024 AACR Annual Meeting
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Insights
The recent findings from Genprex's preclinical studies on Reqorsa® Immunogene Therapy and the Oncoprex® Delivery System highlight noteworthy progress in the realm of targeted cancer therapies. The data indicating REQORSA's ability to induce apoptosis in drug-resistant non-small cell lung cancer (NSCLC) cell lines suggests a potential breakthrough in overcoming resistance to ALK-inhibitors like alectinib. This could be particularly significant for patients with EML4-ALK positive NSCLC who have limited treatment options after developing resistance to first-line therapies.
The reported anti-tumor immune response associated with NPRL2 gene therapy in KRAS/STK11mt NSCLC, a notoriously difficult variant to treat due to its resistance to immunotherapies like pembrolizumab, underscores the importance of exploring novel gene therapies. The role of dendritic cells and cytotoxic immune cell activation in mediating this response could provide a new therapeutic avenue for patients with this mutation.
Lastly, the differential effects of TUSC2 on energy metabolism in cancerous versus normal cells provide insights into potential metabolic vulnerabilities of cancer cells. Targeting these metabolic pathways could be a strategic approach to cancer treatment, potentially leading to therapies that have a selective impact on cancer cells while sparing normal cells.
Investor interest in Genprex is likely to be influenced by the company's ability to advance its gene therapies through the clinical pipeline successfully. The positive preclinical data presented at the AACR meeting could have a favorable impact on the company's valuation, given the high unmet need for innovative treatments in oncology, especially for conditions like NSCLC with genetic mutations that render them resistant to current therapies.
However, it's essential to consider the inherent risks associated with investing in biotech companies, particularly those in the clinical stage. The transition from preclinical to clinical efficacy, regulatory approvals and eventual commercialization is fraught with challenges. It is also important to monitor the competitive landscape, as other companies may be developing similar therapies which could impact Genprex's market share and growth potential.
Long-term investors should evaluate the robustness of Genprex's intellectual property, the scalability of the Oncoprex® Delivery System and the company's ability to secure partnerships or funding to bring these therapies to market. Short-term market reactions to such news may not fully reflect the complexities and timeframes of drug development.
Genprex's announcement regarding their preclinical studies touches upon regulatory and intellectual property aspects that are critical in the pharmaceutical industry. The progression of REQORSA and the Oncoprex® Delivery System through preclinical studies is a step towards potential FDA consideration. However, it is important to note that preclinical success does not guarantee regulatory approval and the path to market authorization is often long and uncertain.
Furthermore, Genprex's ability to protect its intellectual property, including patents for REQORSA, NPRL2 gene therapy and the delivery system, will be vital for maintaining a competitive edge. The company must navigate complex patent laws and potential litigation, which can be common in the high-stakes arena of cancer therapeutics. Investors should be aware of these legal challenges and their implications for the company's future.
As Genprex moves towards clinical trials, compliance with FDA regulations and guidelines will be paramount. Any deviations or setbacks in clinical trials could have significant legal and financial repercussions. Therefore, continuous monitoring of the regulatory landscape and Genprex's adherence to it is essential for stakeholders.
Compelling Data Validates the Potential of Reqorsa® Immunogene Therapy and the Oncoprex® Delivery System as Innovative Cancer Treatments
REQORSA Has Anti-Tumor Mechanisms and Ability to Trigger Cancer Cell Death
"We continue to expand our growing body of preclinical evidence supporting REQORSA's therapeutic potential to treat a variety of cancers, as well as the therapeutic potential of our non-viral delivery system to deliver tumor suppressor genes for the treatment of cancer," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "We are especially delighted to have three preclinical studies presented at one of the largest professional cancer research meetings among the world's top oncologists and the cancer research community."
Featured Genprex-supported posters presented at AACR 2024 include:
Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing Non-Small Cell Lung Carcinoma can induce cellular apoptosis"
Session Category: Molecular/Cellular Biology and Genetics
Session Title: Apoptosis and Ferroptosis
Session Date and Time: Sunday, April 7 from 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 15
Poster Board Number: 7
Abstract Presentation Number: 351
Title: "Mechanism of NPRL2 gene therapy induced anti-tumor immunity in KRAS/STK11mt aPD1 resistant metastatic NSCLC"
Session Category: Immunology
Session Title: Inflammation, Host Factors, and Epigenetic Influences on Cancer Development and Treatment
Session Date and Time: Monday, April 8 from 9:00 a.m. – 12:30 p.m. PT
Location: Poster Section 5
Poster Board Number: 18
Abstract Presentation Number: 1420
Title: "Tumor Suppressor Gene TUSC2 suppresses energy metabolism in lung cancer cells with opposite effects in normal bronchial epithelial cells"
Session Category: Experimental and Molecular Therapeutics
Session Title: Cancer Biology and Metastasis
Session Date and Time: Monday, April 8 from 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 22
Poster Board Number: 6
Abstract Presentation Number: 3158
In the first poster, entitled "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing Non-Small Cell Lung Carcinoma can induce cellular apoptosis," researchers reported that REQORSA induced apoptosis in alectinib resistant EML4-ALK positive non-small cell lung cancer (NSCLC) cell lines. Alectinib is an ALK-inhibitor commonly used to treat patients with ALK rearrangements such as EML4-ALK positive NSCLCs. This research suggests that REQORSA may be an effective treatment in patients progressing on alectinib.
The second poster, entitled, "Mechanism of NPRL2 gene therapy induced anti-tumor immunity in KRAS/STK11mt aPD1 resistant metastatic NSCLC" detailed a humanized mouse model study in which the researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC. In the study, lung metastases in humanized mice were treated through I.V. injection of NPRL2 nanoparticles, made with the ONCOPREX Delivery System, with or without pembrolizumab. The study found that the NPRL2 treatment by itself led to a marked decrease in the size of lung metastases but pembrolizumab had no effect. Additionally, a greater anti-tumor effect was seen in humanized compared to non-humanized mice, demonstrating that immune cells play a role in the effects of the NPRL2 nanoparticle therapy. Study findings suggest that NPRL2 gene therapy induces anti-tumor activity against KRAS/STK11mt tumors through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation. The Company believes this data could support the potential for a new drug candidate in its pipeline, and it also provides further evidence for the Company's belief that the ONCOPREX Delivery System has the ability to be successful using genes other than the TUSC2 gene the Company is already using in clinical trials with REQORSA.
In the third poster, entitled, "Tumor Suppressor Gene TUSC2 suppresses energy metabolism in lung cancer cells with opposite effects in normal bronchial epithelial cells" researchers reported that TUSC2-deficient cancer cells consistently exhibited decreased glycolytic rates and mitochondrial ATP production, leaving these cells without enough energy to support their vital functions. By comparison, when Beas2B, a normal human bronchial epithelial cell line with normal levels of TUSC2, was transfected with a TUSC2 containing plasmid, the glycolytic rate and mitochondrial metabolism was increased. This suggests the mechanism by which REQORSA treatment affects immune and other non-cancerous cells that leads to increased immune response against tumors. The study further suggested that REQORSA may play an important role as a cancer treatment to target and disrupt the metabolism of cancer cells, leading to a decrease in the rate of glycolysis.
These AACR posters have been made available on Genprex's website at www.genprex.com.
About Reqorsa® 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 The Oncoprex® Delivery System
Genprex's ONCOPREX Delivery System is a novel non-viral approach that utilizes lipid-based nanoparticles in a lipoplex form 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 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® 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-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; 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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