- Clinical Trials
Our oncology program uses a modern combinational treatment approach to fight cancer, utilizing our lead drug candidate, GPX-001 and our unique, proprietary, non-viral Oncoprex™ nanoparticle delivery platform combined with approved targeted therapies and immunotherapies. This enables us to offer hope to large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them.
Our research indicates that when GPX-001, our lead drug candidate for non-small cell lung cancer (NSCLC), is combined with targeted therapies (such as Tarceva® (erlotinib) or Tagrisso® (osimertinib)) or immunotherapies (such as Opdivo® (nivolumab) or Keytruda® (pembrolizumab)), GPX-001 is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining GPX-001 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.
Targeted therapies work by targeting the cancer or disease’s specific gene, protein or tissue that contributes to the disease while sparing normal tissue. Unfortunately, targeted therapies require patients to have an activating genetic mutation specific to the drug. In NSCLC, the vast majority of lung cancer patients do not have the genetic mutations 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 mutation. In addition, the few patients who do have the genetic mutation qualifying them to receive targeted therapies are likely to develop resistance to these drugs over time.
In January 2020, we received a United States FDA Fast Track Designation for use of GPX-001 in combination with EGFR inhibitor osimertinib (AstraZeneca’s Tagrisso®) for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. The median length of time that patients are treated with osimertinib before their tumors progress is approximately eighteen (18) months.
Immunotherapy is a type of treatment that helps the immune system fight disease. Biomarker testing can help determine if high levels of PD-1/PD-L1 proteins are detected in the patient, signifying that the body’s immune system is not working to fight cancer or disease as it should. These patients could qualify for approved immunotherapies, however, only about 12 percent of patients benefit from immunotherapies.
Genprex is conducting preclinical studies to evaluate GPX-001 in combination with checkpoint inhibitors. Preclinical data indicate that Genprex’s lead drug candidate is synergistic with checkpoint inhibitors, such as pembrolizumab (Merck’s Keytruda®), meaning that the combination of drugs may be more effective than checkpoint inhibitors alone. Preclinical data also indicates that a three-drug combination of a checkpoint inhibitor, chemotherapy, and GPX-001 may be more effective than the two-drug combination of a checkpoint inhibitor and chemotherapy.
Osimertinib (AstraZeneca’s Tagrisso®) had more than $3 billion in worldwide gross sales in 2019, and Tagrisso is AstraZeneca’s highest grossing product. Given Genprex’s Fast Track Designation and Tagrisso’s status as the current standard of care in EGFR-mutated NSCLC, we have prioritized the clinical development of GPX-001 in combination with Tagrisso. We believe this regulatory pathway positions us well in the $17.9 billion global lung cancer market, especially given the advantages of our Fast Track Designation status.
Pembrolizumab (Merck’s Keytruda®) generated $11.1 billion in worldwide sales in 2019, and Keytruda is Merck’s highest grossing product. Keytruda is the standard of care in non-EGFR mutated NSCLC. Genprex plans to initiate a Phase I clinical trial evaluating GPX-001 in combination with pembrolizumab.
Tarceva® is a registered trademark of Astellas and the Roche Group of companies.
Tagrisso® is a registered trademark of AstraZeneca.
Opdivo® is a registered trademark of Bristol-Myers Squibb.
Keytruda® is a registered trademark of Merck.