Genprex, Inc. (NASDAQ: GNPX) – Empowering Lives, Surpassing Boundaries – Giving New Hope , Cutting-Edge Solutions, and a Journey to a Brighter Future.

Genprex Granted Orphan Drug Designation in Small Cell Lung Cancer

REQORSA® Breaks Ground as an Advanced Immunogene Treatment – Bringing Hope to Lung Cancer Patients!

REQORSA by Genprex is a cutting-edge cancer treatment, delivering TUSC2 and NPRL2 genes via a non-viral lipid nanoparticle system. Designed to reverse glycolysis in cancer cells, it aims to restore tumor suppressor functions and enhance anti-cancer mechanisms. With promising results, REQORSA represents a new frontier in cancer therapy.

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

"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,"

"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."

By Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.

We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer,

By Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.

In 2023, we also received a third Fast Track Designation for Reqorsa® Immunogene Therapy from the U.S. Food and Drug Administration, this time in combination with Tecentriq® for the treatment of small cell lung cancer, and REQORSA was also granted Orphan Drug Designation for the treatment of small cell lung cancer. We believe these designations underscore and further validate the potential of REQORSA. Our accomplishments in 2023, which also include process improvements in our manufacturing operations and securing new supplies of REQORSA, sets the foundation for a strong 2024.

Greetings Investors,

Genprex, Inc. (NASDAQ:GNPX) are integral to our mission of revolutionizing healthcare through groundbreaking gene therapies. With your support, we're reshaping treatment possibilities for patients grappling with cancer and diabetes. At Genprex, we're driven by a steadfast dedication to innovation and pioneering scientific discoveries, propelling us forward as a leading force in the biotechnology sector.

Building on Success: Genprex enters 2024 on a foundation of notable achievements in 2023. Our completion of the Phase 1 segment of the Acclaim-1 trial, coupled with FDA Fast Track Designations and Orphan Drug Designations, underscores our commitment to innovation in cancer and diabetes therapies. These milestones signal our readiness to deliver impactful treatments and drive shareholder value.

Oncology Innovation: Our oncology gene therapy platform, anchored by the Oncoprex® Nanoparticle Delivery System, continues to advance. With REQORSA® leading in three clinical trials targeting NSCLC and SCLC, and an expanding patent portfolio, we're positioned as leaders in cancer therapy innovation, promising long-term value for investors.

Clinical Milestones: In 2024, pivotal advancements are expected, including the Phase 2a expansion of Acclaim-1 and initiation of Acclaim-3 Phase 1. With encouraging Phase 1 Acclaim-1 results and ongoing collaborations driving preclinical data presentations, we're poised for clinical success and value creation.

Genprex's portfolio isn't limited to oncology; it extends to tackling the diabetes epidemic. Our gene therapy program for diabetes, centered around GPX-002 and GPX-003, aims to restore insulin levels and revolutionize the lives of individuals impacted by diabetes.

Strategic Collaborations: Partnerships with institutions like the University of Pittsburgh strengthen our R&D capabilities. Collaborations drive research advancements, enhancing our position as pioneers in gene therapy. Abstract submissions and data presentations at esteemed conferences underscore our commitment to transparency and progress sharing.

Global Impact: With a growing global intellectual property portfolio, continuous collaborations, and strategic alliances, Genprex is primed for monumental expansion. Embark on this thrilling expedition with us as we venture into new therapeutic areas, involve influential thought leaders, and pave the path for cutting-edge gene therapies in the 21st century.

Genprex, Inc. (NASDAQ: GNPX) - Pioneering Gene Therapies for Cancer and Diabetes, Revolutionizing Lives, and Creating Shareholder Value.

Top Reasons to Have GNPX on Your Radar

  • 01
    Strong Buy Rating On NASDAQ: Analysts at H C WAINWRIGHT have given Genprex, Inc. (GNPX) a strong buy rating , with a 12-month price target of $10.
  • 02
    Innovative Gene Therapies: Genprex leads the charge in developing groundbreaking gene therapies for cancer and diabetes, offering hope to millions worldwide.
  • 03
    Clinical Advancements: With ongoing Phase 2a and Phase 1 clinical trials for Acclaim-1 and Acclaim-3 respectively, Genprex is at the forefront of advancing treatments for lung cancer patients.
  • 04
    FDA Recognition: The FDA's Fast Track Designations and Orphan Drug Designations for REQORSA underscore its potential as a game-changer in small cell lung cancer treatment.
  • 05
    Multimodal Approach: REQORSA's unique mechanism of action, targeting multiple pathways in cancer cells, promises more effective and complementary treatment options for patients.
  • 06
    REQORSA Immunogene Therapy: REQORSA, our flagship product, stands out as a pioneering immunogene therapy, showcasing effectiveness both as a standalone treatment and in synergistic combinations with targeted therapies such as Tarceva, Tagrisso, and Keytruda.
  • 07
    Research Milestones: Significant preclinical data presented at prestigious conferences and ongoing research collaborations with esteemed institutions like the University of Pittsburgh validate Genprex's scientific prowess.
  • 08
    Strategic Vision: Genprex's commitment to driving innovation, engaging key opinion leaders, and forging strategic partnerships ensures its position as a leader in 21st-century gene therapies.
  • 09
    Diabetes Program: Targeting both Type 1 and Type 2 diabetes, our AAV gene therapy prospects, GPX-002 and GPX-003, stand as potential transformative solutions, instilling optimism in millions through proven advancements in preclinical trials.
  • 10
    Treatment Approach: Tackling cancer by reintroducing tumor suppressor genes, our systemic gene therapy platform, ONCOPREX® Nanoparticle Delivery System, delivers genes selectively to cancer cells, providing a groundbreaking treatment modality.
  • 11
    Global Impact on Lung Cancer: With lung cancer statistics staggering, our approach targeting NSCLC, SCLC, and other cancers, aims to combat drug resistance, enhance treatment efficacy, and improve overall survival rates.
  • 12
    Outlook: With upcoming milestones in Acclaim trials, preclinical studies, and engagements with FDA, Genprex is poised for a transformative future, exploring new indications, expanding its IP portfolio, and pioneering the next era of patient care.

Keep an eye on Genprex (NASDAQ: GNPX) as it navigates the frontier of gene therapy, offering hope, innovation, and value to patients and shareholders alike.

Genprex Expands Clinical Trial Sites for Acclaim-3 Clinical Study of Reqorsa® Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer

"With the majority of oncology patients treated by community-based oncology practices, this collaboration to expand our Acclaim-3 clinical study to additional trial sites is important as it may accelerate patient enrollment, provide access to our innovative clinical trial treatment for patients outside of major urban or academic settings, broaden the geographic reach of our study to more ES-SCLC patients in need and potentially benefit ES-SCLC patients who currently have limited benefit from existing treatment options,"

"This collaboration leverages the broad network of oncologists and enables patients to access our promising treatment at the office of their primary oncologist, while allowing Genprex to more efficiently and expeditiously accelerate our Acclaim-3 clinical trial."

By Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.

Company Overview

Genprex's Breakthrough Gene Therapies for Cancer and Diabetes

Our mission is to develop life-changing gene therapies for patients with cancer and diabetes through unique, innovative science.

Tackling a Global Challenge: Addressing a Prevalent Problem with Innovative Solutions

Amidst the realms of cancer and diabetes treatment lies a daunting challenge: the limitations of conventional therapies in meeting the multifaceted needs of patients. Lung cancer patients often confront restricted options, grappling with drug resistance to common medications like Tagrisso®, Keytruda®, and Tecentriq®.

Simultaneously, the diabetes crisis persists, with millions enduring compromised quality of life due to outdated treatment methods, unchanged since insulin's inception in 1922. This glaring disparity underscores the urgent need for effective, sustainable solutions— a void that Genprex endeavors to bridge through its groundbreaking gene therapies.

Our unwavering dedication to reshaping patient care via innovative technologies serves as a glimmer of hope for those impacted by these debilitating illnesses. By addressing this widespread challenge head-on, we herald a new epoch of transformative healthcare, promising renewed hope and improved outcomes for patients worldwide.

Revolutionizing Healthcare: Genprex's Innovative Solutions for Cancer and Diabetes

Genprex leads the charge in transformative healthcare, providing pioneering solutions to the prevalent obstacles in cancer and diabetes treatment. Through our cutting-edge non-viral gene therapy platform, we introduce a revolutionary method to combat lung cancer by systematically replacing tumor suppressor genes. REQORSA®, our flagship product candidate, symbolizes a beacon of optimism, showcasing promising results in clinical trials, including instances of tumor regression and enhanced patient responses.

In the realm of diabetes, our gene therapy contenders, GPX-002 and GPX-003, exhibit unparalleled potential. Designed to tackle both Type 1 and Type 2 diabetes, these candidates, delivered via an innovative infusion process, strive to restore normal blood glucose levels for extended durations. With a mission to redefine the landscape of cancer and diabetes treatment, Genprex is dedicated to propelling these groundbreaking gene therapies forward, bridging the divide in conventional therapies and steering towards a future where patients can embrace life with revitalized hope and heightened quality.

TECHNOLOGIES

Innovative Technologies for Advancing Cancer and Diabetes Gene Therapies – Explore the Future of Healthcare Innovation!

21st Century Gene Therapies

Our 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. Our teams work closely with world-class researchers, institutions and industry collaborators to expand our pipeline of gene therapies and provide a wider range of novel treatment approaches for patients with cancer and diabetes.

Systemic Gene Therapy Platform for Cancer

Genprex’s oncology drug development program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. Using this system, we encapsulate plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells.

REQORSA® Immunogene Therapy

REQORSA® Immunogene Therapy, Genprex's flagship product candidate for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), utilizes the innovative ONCOPREX® Nanoparticle Delivery System, delivering the TUSC2 tumor suppressor gene. This therapy aims to disrupt cancer cell signaling pathways, induce cancer cell death, and enhance the immune response against cancer, serving as a blend of gene therapy and immunotherapy. Notably, REQORSA received Fast Track Designations from the FDA in 2020 and 2021 for its combinations with AstraZeneca's Tagrisso® and Merck & Co's Keytruda®, respectively, and in 2023 for its combination with Genentech, Inc.'s Tecentriq® in extensive-stage small cell lung cancer (ES-SCLC) patients.

Administered intravenously, REQORSA's non-viral nanoparticles target cancer cells specifically, delivering the TUSC2 gene while minimizing uptake by normal tissues. Tumor biopsy studies revealed significantly higher uptake of TUSC2 in tumor cells compared to normal cells, demonstrating REQORSA's targeted delivery efficacy.

Unlike many gene therapies requiring permanent DNA changes, REQORSA does not integrate into the patient's DNA, simplifying administration.

REQORSA boasts a multimodal mechanism of action, disrupting cancer cell replication and survival pathways, inducing apoptosis, and modulating the immune response. This versatility extends to combination therapies, where REQORSA has shown promising results in preclinical and clinical studies, potentially offering effective treatment options for a wide range of lung cancer patients.

GPX-002 and GPX-003

Genprex's diabetes gene therapy program introduces GPX-002, a groundbreaking solution developed in collaboration with the University of Pittsburgh. This therapy employs a novel infusion method using an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas. In Type 1 diabetes models, these genes prompt alpha cells to transform into functional beta-like cells, capable of producing insulin while evading immune detection. Similarly, in Type 2 diabetes, GPX-003 aims to revitalize exhausted beta cells, offering potential long-term relief.

The innovative approach of Genprex's gene therapies extends to both Type 1 and Type 2 diabetes, utilizing the same AAV vector technology for targeted delivery. Preclinical studies conducted at the University of Pittsburgh are optimizing these therapies, paving the way for future clinical trials. GPX-002's efficacy in restoring normoglycemia and increasing insulin-producing cell mass has shown promising results in diabetic mouse models and nonhuman primates.

Recent presentations of preclinical data at international conferences underscore the therapeutic potential of GPX-002 and GPX-003. Statistically significant outcomes in nonhuman primates include decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance. These findings suggest a transformative breakthrough in diabetes treatment, with the potential to eliminate the need for insulin replacement therapy in both Type 1 and Type 2 diabetic patients.

ONCOPREX® Nanoparticle Delivery System

Genprex's ONCOPREX® Nanoparticle Delivery System marks a pioneering advancement in oncology, revolutionizing the delivery of anti-cancer genes. Developed through collaborative research with esteemed institutions like the University of Texas MD Anderson Cancer Center and the National Institutes of Health, this non-viral platform delivers DNA plasmids containing cancer-fighting genes encapsulated in lipid nanoparticles intravenously to patients.

The ONCOPREX® system is optimized to deliver therapeutic payloads systemically, targeting cancer cells with precision. Utilizing positively charged nanoparticles, it selectively binds to negatively charged cancer cells and enters them through selective endocytosis. This unique approach ensures efficient delivery of therapeutic genes while minimizing uptake by normal cells.

Key to the efficacy of Genprex's delivery system is the optimized particle size, designed to navigate tight barriers in the lung while avoiding accumulation in vital organs like the liver, spleen, and kidney. Phase 1 clinical trials have demonstrated selective targeting of tumor cells, resulting in significant anticancer activity with minimal immunogenicity, allowing for repetitive therapeutic dosing.

With over 50 patients enrolled in Phase 1 and 2 clinical trials, Genprex has established the safety and efficacy of REQORSA® therapy using the ONCOPREX® Nanoparticle Delivery System. The therapy has shown promising results in selectively targeting tumor cells, demonstrating clinically significant anticancer activity while being well tolerated in humans. This groundbreaking approach represents a significant milestone in systemic gene therapy, offering new hope in the fight against cancer.

GENPREX EXPANDS NONCLINICAL PROGRAMS INTO NEW THERAPEUTIC INDICATIONS WITH RESEARCH

"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," "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."

By Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.

PROGRAMS

Explore Oncology and Diabetes Programs, Gene Therapies for Unmet Medical Needs and Transformative Patient Outcomes!

Oncology Combination Treatment Approach

Genprex's oncology program adopts a cutting-edge combination treatment approach, merging REQORSA® immunogene therapy with our proprietary ONCOPREX® nanoparticle delivery system alongside approved targeted therapies and immunotherapies. This strategy offers renewed hope to large patient populations ineligible for these therapies or those who develop resistance.

Research demonstrates the synergistic effect of REQORSA when combined with targeted therapies like Tarceva or Tagrisso, and immunotherapies such as Opdivo or Keytruda. By leveraging this synergy, we aim to extend the benefits of these drugs to patients previously ineligible or resistant due to molecular profiles or drug tolerance.

Our combination trials pave the way for expanding treatment options, addressing the limitations of targeted therapies which require specific genetic mutations. In January 2020, FDA granted Fast Track Designation for REQORSA in combination with Tagrisso for NSCLC patients with EFGR mutations post-progression.

Additionally, our preclinical studies explore REQORSA's potential in combination with checkpoint inhibitors like Keytruda, indicating promising synergistic effects. This innovative approach holds promise for enhancing treatment efficacy beyond conventional therapies, ushering in a new era in cancer care.

Lung Cancer

Cancer is a multifaceted illness characterized by uncontrolled cell growth, disrupting normal bodily functions. Lung cancer, Genprex's primary focus, encompasses non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). According to the World Health Organization, lung cancer is the foremost cause of cancer-related deaths globally, surpassing colorectal, breast, liver, and stomach cancers in mortality rates.

In 2020, over 2 million new cases of lung cancer were reported worldwide, with 1.8 million resulting in fatalities. In the United States alone, projections by the American Cancer Society estimate more than 236,000 new lung cancer cases and over 130,000 deaths in 2022. NSCLC comprises 84% of lung cancer cases, with a five-year survival rate of merely 7% for those with distant metastasis. SCLC accounts for around 13% of lung cancer cases, with a dismal five-year survival rate of 3% in cases with distant spread.

Given the limited efficacy of existing therapies, there exists a substantial unmet medical need for innovative treatments for both NSCLC and SCLC globally. Genprex believes its lead candidate, REQORSA, holds promise as a viable option for the majority of lung cancer patients, addressing this critical gap in care.

Genprex Announces First Patient Dosed in Phase 2a Expansion of Acclaim-1 Clinical Study of Reqorsa® Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer

  • Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024
  • Acclaim-1 Study Has FDA Fast Track Designation

"We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso," "We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints."

By Mark Berger, Chief Medical Officer of Genprex.

Diabetes

Our diabetes gene therapy candidate, GPX-002, is being developed for the treatment of diabetes. According to the U.S. Center for Disease Control, 37 million Americans, or approximately 11% of the population, have diabetes. It is also believed that more than 96 million Americans have prediabetes, which represents approximately 38% of the U.S. population. The prevalence of this chronic disease is continuing to rise.

Chronic diabetes conditions include Type 1 diabetes and Type 2 diabetes, both of which lead to excess sugar in the blood and can cause serious health problems. Left untreated, high blood sugar levels can damage eyes, kidneys, nerves, and the heart, and can also lead to coma and death.

Clinical Trials of REQORSA and Advanced Diabetes Therapies — Paving the Way for Groundbreaking Treatments Across Cancers and Diabetes.

Genprex pioneers cutting-edge technologies, aiming to revolutionize cancer and diabetes treatments. REQORSA, our lead product for lung cancer, is explored in tandem with targeted therapies and immunotherapies. Ongoing research extends the application to diverse tumors. Our non-viral ONCOPREX platform underpins these advancements. In diabetes, GPX-002 and GPX-003 promise breakthroughs. Our dynamic pipeline signifies our commitment to transforming patient care with innovative gene therapies.

In Summary…

Revolutionizing Healthcare: Genprex stands at the forefront of transformative healthcare, pioneering gene therapies that redefine the treatment landscape for cancer and diabetes. Leveraging cutting-edge technologies and innovative science, we are committed to addressing the prevalent challenges in traditional therapies, offering groundbreaking solutions to patients worldwide.

Unmet Medical Needs: In the realm of cancer and diabetes treatment, significant unmet medical needs persist, affecting millions globally. With lung cancer ranking as the leading cause of cancer deaths and diabetes prevalence on the rise, there is a pressing demand for novel treatments that can provide hope and improve patient outcomes.

Breakthrough Therapies: Our lead product candidate, REQORSA® Immunogene Therapy, represents a paradigm shift in cancer care, demonstrating promising outcomes in clinical trials. By leveraging our proprietary ONCOPREX® Nanoparticle Delivery System, REQORSA offers a targeted approach to combatting cancer, potentially reversing tumor growth and enhancing patient responses.

Expanding Opportunities: In addition to our oncology pipeline, Genprex is spearheading innovative gene therapies for diabetes, addressing both Type 1 and Type 2 diabetes with our GPX-002 and GPX-003 candidates. These therapies offer hope to millions by targeting the root causes of the disease and restoring normal function to pancreatic cells.

Investment Potential: With upcoming milestones in clinical trials, promising preclinical data, and strategic partnerships, Genprex presents an enticing investment opportunity in the rapidly evolving field of biotechnology. Join us as we pave the way for groundbreaking treatments that have the potential to transform lives and generate significant value for shareholders.

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(Last updated: May 04, 2024 @ 9:15 AM)