A Potential NSCLC Treatment for Large Patient Populations
July 18, 2019
Today’s cancer treatment options are not one-size-fits-all. But Genprex, a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based on a unique proprietary technology platform, is working on developing its initial drug candidate for NSCLC that would potentially benefit a large patient population who cannot currently benefit from approved therapies.
In non-small cell lung cancer (NSCLC), gene and biomarker testing remain an important aspect of treatment. Cancer treatments are often tailored to the patient based on the patient’s genetic makeup. But oftentimes patients’ genetic makeup are not the right fit to be able to benefit from approved drugs. And many patients who have the right genetic makeup to be able to take these approved drugs eventually build up a resistance to these drugs over time, rendering the drugs inneffective.
Genprex’s initial drug candidate, Oncoprex™ immunogene therapy, aims to target the majority of NSCLC patients who, due to their genetic profiles, do not qualify for other approved drugs. Additionally, for patients who do qualify for certain approved drugs but develop a resistance to them, Genprex’s drug candidate may re-sensitize these patients and allow continued benefit from these drugs.
Biomarker tests are used to help learn more about the patient’s genetic makeup, which can lead to a more personalized approach to treatment. Specific to NSCLC, there are a number of genetic mutations the patient could be tested for in order to learn which treatments they will likely respond to the best. However, the vast majority of lung cancer patients do not have the “druggable” mutations found in lung cancer that qualify them for targeted therapies, such as the EGFR or ALK gene. One study found that only about 10 percent of NSCLC patients had the EGFR mutation1. Additionally, there are not enough approved targeted and immunotherapies to treat all of the gene mutations.
Patients can also be tested for PD-1/PD-L1 checkpoint inhibitor proteins. High levels of these proteins would signify that the body’s immune system has turned on the brakes for those cancer-fighting checkpoint inhibitors, which does not allow the immune system to work as well as it should. These patients could qualify for approved immunotherapies, however, only about 25 percent of NSCLC patients have high enough levels of PD-L1 proteins to be able to benefit from immunotherapies2, and few patients respond to approved immunotherapies when taking these drugs alone.
Building Resistance to Drugs
The few patients who do have the right genetic mutation to receive some of the available targeted and immunotherapies may develop resistance to these drugs over time3. Cancer can change and grow, which can lead to therapies that once worked for the patient, to stop working. In some cases, patients may change their treatment approach after trying first-line or second-line treatment.
Bridging the Gap
Genprex is bridging a critical gap in cancer treatment by combining its immunogene therapies with targeted and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those drugs, or who have developed resistance to those drugs.
The company is conducting Phase I/II clinical trial to evaluate the effectiveness of Oncoprex in combination with erlotinib in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on erlotinib therapy. Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients are generally not candidates for erlotinib therapy.
Preclinical and clinical data show that Oncoprex works synergistically with erlotinib to help destroy the cancer cells and may help patients who have become resistant to erlotinib alone.
Genprex is also conducting preclinical studies to evaluate Oncoprex in combination with checkpoint inhibitors.
Preclinical data shows that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy and could result in a stronger antitumor response compared to either agent alone.
*Oncoprex is currently in development and is not FDA approved.
- US National Library of Medicine National Institutes of Health; Journal of Genes & Cancer https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527990/
- Utswmed.org. (2019). Not a cure, but an extension: How immunotherapy works for advanced lung cancer | Cancer | UT Southwestern Medical Center. [online] Available at: https://utswmed.org/medblog/advanced-lung-cancer-immunotherapy/ [Accessed 22 Apr. 2019].
- Meyers DE, Bryan PM, Banerji S, Morris DG. Targeting the PD-1/PD-L1 axis for the treatment of non-small-cell lung cancer. Curr Oncol. 2018;25(4):e324–e334. doi:10.3747/co.25.3976