BioMedWire Editorial Coverage: Pharmaceutical companies are now employing advanced medical breakthroughs and new technologies, including gene therapies and nanoparticle engineering, to fight every type of cancer.
- Gene therapies are being developed to more effectively target the treatment of cancer.
- Non-small cell lung cancer (NCSLC) is the leading cause of cancer death.
- Genprex Inc. is advancing Oncoprex, shown to benefit lung cancer patients in early trials.
A multiplicity of potential breakthrough treatments to fight cancer are in varying stages of clinical development, and many are focused on the promise of advanced gene therapies. Genprex Inc. (NASDAQ: GNPX) (GNPX Profile) is working to bring its potentially life-changing immunogene therapy, Oncoprex, to market. Pfizer Inc. (NYSE: PFE) just gained Food and Drug Administration (FDA) approval for TRAZIMERA(TM), and Tocagen Inc. (NASDAQ: TOCA) is studying Toca 511. Novartis AG (NYSE: NVS) scientists are exploring immunotherapy matchmaking. Other biotechnology companies such Audentes Therapeutics Inc. (NASDAQ: BOLD) are developing innovative gene therapy products for patients living with life-threatening rare diseases.
Targeting Cancer with Advanced Gene Therapies
According to Dr. C.H. Weaver, most cancers result from abnormal genes or gene regulation, and cancer drugs that target those genes or the consequences of those genes can be used to target the cancer. Weaver writes, “Because precision cancer medicine seeks to define the genomic alterations that are driving a specific cancer, rather than relying on a simple broad classification of cancer solely based on its site there is no longer a ‘one-size-fits-all’ approach to cancer treatment.”
The first human gene therapy trial was approved in 1989. Between 1989 and 2015, more than 2,300 gene therapy clinical trials were completed, in progress, or approved to begin. The United States undertook 67 percent of these gene therapy clinical trials, with most of them targeting cancer. The first gene therapy was approved for use in the European Union (EU) in 2012, and that approval spurred enormous investment into developing what many believe to be the answer to cancer: gene therapeutics.
Targeted Treatment for Cancer’s Biggest Killer
Genprex Inc. (NASDAQ: GNPX) is on the cusp of potentially delivering life-changing therapeutics for cancer patients by utilizing the company’s novel proprietary technology platform. Genprex’s initial product candidate, Oncoprex, an immunogene therapy for non-small cell lung cancer (NSCLC), addresses the world’s leading cause of cancer death, which kills more than 140,000 patients in the United States each year alone.
Oncoprex encapsulates TUSC2, a powerful proven tumor suppressor gene, in a cholesterol nanoparticle engineered to target cancer cells. As Genprex chairman and CEO Rodney Varner explained, “It’s a systemic targeted approach. We say that the treatment is ‘targeted’ because the lipid nanoparticles are designed to be attracted like a magnet to the cancer cells, and have an opposite charge.”
Administered intravenously and absorbed into tumor cells, Oncoprex then expresses proteins that are missing or found in low quantities. Oncoprex interrupts cell signalling pathways that cause the replication and proliferation of cancer cells, re-establishes pathways for programmed cell death in cancer cells, and modulates the immune response against cancer.
Genprex’s collaborators have demonstrated through tumor biopsies that its patented, targeted, nanoparticle delivery system provides up to 25 times greater uptake of the TUSC2 tumor suppressor gene, which is the active ingredient in Oncoprex, in tumor cells than in normal cells. Research has also shown that Oncoprex, in combination with targeted or immunotherapies, may be more effective than single drugs alone. As well as being a tumor suppressor, Oncoprex has shown to have a favorable safety profile relative to other lung cancer drugs, and to block mechanisms that create drug resistance.
Genprex states that “we believe that by combining Oncoprex with approved targeted therapies and immunotherapies, we can potentially expand the benefit of these approved lung cancer drugs into the large majority of patients who do not now benefit from them, either because the patients’ tumors do not have the molecular profiles that indicate effectiveness of those drugs, or because the patients have developed resistance to those drugs after receiving them for some period of time.”
In addition, the company notes that current targeted therapies generally only benefit patients with particular epidermal growth factor receptor (EGFR) mutations, which are a minority of patients. Pre-clinical and clinical trials suggest that Oncoprex, combined with existing targeted treatments, may be effective in fighting cancer in the population at large, regardless of EGFR mutation.
Patents and Beyond
Genprex already has 30 issued patents for its platform technologies and gene therapies. The company’s Oncoprex immunogene therapy combined with the targeted therapy erlotinib is in the Phase II portion of a Phase I/II clinical trial, and the combination of Oncoprex with immunotherapies is in preclinical development. The company is also conducting research to find biomarkers to identify patients most likely to benefit from Genprex treatments, as well as other drugs that will be synergistic with Genprex gene therapies.
Given the enormous potential and unmet medical need, Genprex plans to apply for Fast Track, Breakthrough or RMAT designation from the FDA.
In 2008, Varner recognized the enormous potential in the science behind Genprex’s lead drug candidate, Oncoprex. A corporate lawyer for several biotech start-ups and a cancer survivor himself, Varner, along with several leading scientists, rescued what they believed was the most promising, undeveloped science of a bankrupt biotech: the TUSC2 tumor suppressor gene delivered to tumor cells through a novel nanoparticle delivery system. The group became the foundation of what is today Genprex.
Lead by Varner, Genprex boasts some of the world’s best scientific minds. Internationally renowned cancer expert and oncology pioneer Jack A. Roth, MD, FACS, is the chairman of Genprex’s Scientific Advisory Board. Genprex president Julien L. Pham, MD, MPH, was on the faculty at Harvard Medical School’s Brigham and Women’s Hospital (BWH) prior to founding a healthcare IT company.
Employing cutting-edge science, Genprex is establishing a new paradigm in the fight against lung cancer. Given the vast unmet global need and the breakthrough potential of Genprex’s pipeline, investors may want to keep the company on their watch list.
Other Gene Therapy Approaches
The FDA recently approved Pfizer’s (NYSE: PFE) TRAZIMERA for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. A biosimilar to Herceptin, TRAZIMERA targets certain proteins preventing cancer cell division and growth targeting breast cancer treatments. The company sees this as an “important milestone” in the United States. Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development.
Tocagen’s (NASDAQ: TOCA) Toca 511 is a retroviral replicating vector (RRV) that selectively targets cancer cells in aggressive brain tumors. It delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. The second part of Tocagen’s treatment is an investigational small molecule, Toca FC. This is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.
Immunotherapy matchmaking exploration by Novartis AG (NYSE: NVS) could enable the company to better pair the right immunotherapy with the right patient. Novartis aims to answer the question: why do some patients respond to a therapy when other seemingly similar patients do not? Novartis AG scientists are using artificial intelligence (AI) to find clues. Novartis focuses on five key cancer areas where it has identified patient needs and promise within the company’s portfolio. Those areas are breast cancer, lung cancer, melanoma, kidney cancer and hematology.
Audentes Therapeutics Inc. (NASDAQ: BOLD) is working on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases. The company has four products in development: AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar Syndrome, AT307 for the treatment of CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and AT845 for the treatment of Pompe disease.
With advancing technological and research capabilities, pharmaceutical companies are looking to identify breakthrough treatments, including gene therapies and nanoparticle engineering, to tackle cancer of every kind. Genprex is working to establish its place as a leader in the field.
For more information on Genprex, visit Genprex Inc. (NASDAQ: GNPX)
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