Genprex™ is a clinical stage gene therapy company developing a new approach to treating cancer, based on our novel proprietary technology platform, including our initial product candidate – Oncoprex™ immunogene therapy – or, Oncoprex. Our platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (or programmed cell death) in cancer cells, and modulates the immune response against cancer. Oncoprex has also been shown to block mechanisms that create drug resistance. We are currently conducting the second phase of a Phase I/II clinical trial at The University of Texas MD Anderson Cancer Center in Houston, Texas.
Cancer is a complex disease that can start in any site in the body when a tissue grows out of control and inhibits the body’s normal functioning. At the cell level, cancer often involves the dysregulation of multiple genes and cellular pathways, leading to the cell’s inability to maintain proper cellular functions. Re-establishing or blocking these pathways can be done through many therapeutic approaches, including gene therapy. More general information about cancer can be found at The American Cancer Society.
Genprex’s research and development projects are focused on developing new treatments for cancer. Our initial therapeutic target is non-small cell lung cancer (NSCLC). Lung cancer is one of the most prevalent and deadly cancers worldwide, and NSCLC comprises about 85% of lung cancers . The five year survival rate for late stage lung cancer has not improved significantly in the past 25 years despite advances in drug development and novel therapeutic standards. Our objective at Genprex is to develop 21st century gene therapies to improve patient outcomes.
We are developing gene therapies for treatment of cancer, including our initial drug candidate Oncoprex immunogene therapy. Our gene therapies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Our research indicates that when Oncoprex is combined with targeted therapies (such as Tarceva or Iressa) or immunotherapies (such as Opdivo and Yervoy), Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining Oncoprex with targeted therapies and immunotherapies, we can extend 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.
We hold a portfolio of 30 issued and 2 pending patents covering our technologies and targeted molecular therapies.
We are also conducting pre-clinical research to identify biomarkers that will identify patients most likely to benefit from our gene therapies; and to identify additional cancer drugs that will be synergistic with our gene therapies.
As targeted therapies and immunotherapies supplant conventional chemotherapies in lung cancer, many lung cancer patients who do not meet specific genomic profiles are unable to benefit from these new therapies. In fact, a majority of lung cancer patients cannot benefit from targeted therapies or immunotherapies. Genprex seeks to bridge a critical gap by combining its gene therapies with targeted therapies and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those important drugs.
In a phase I/II clinical trial, Genprex’s leading drug candidate, Oncoprex, is being combined with the EGFR TKI drug Tarceva® (erlotinib) in Stage IIIb/IV non-small cell lung cancer (NSCLC) patients without an activating EGFR mutation and in patients with an activating EGFR mutation who progressed on erlotinib, whether or not they had prior chemotherapy. Patients without an activating EGFR mutation represent the vast majority of lung cancer patients, however these patients are usually not candidates for EGFR TKI therapies due to the absence of this mutation.
Oncoprex is being developed to overcome this genomic limitation and provide a new treatment solution to this majority of lung cancer patients who do not have the activating EGFR mutation that would allow them to benefit from EGFR TKI therapies such as Tarceva.
In addition, patients who have the EGFR activating mutation and do receive an EGFR TKI inhibitor such as Tarceva usually become resistant to these drugs at some point, and no longer benefit from them. Data indicate that Oncoprex may re-sensititize these patients to EGFR TKI drugs such as Tarceva, allowing the patients to benefit for a longer period time.