Oncology

Mutations that lead to cancer are usually present in two major classes of genes: oncogenes, which are involved in functions such as signal transduction and transcription; and tumor suppressor genes, which play multiple roles in governing cell growth and proliferation.

The most common genetic alterations present in lung cancer are in tumor suppressor genes.  No targeted small molecule drugs have successfully been developed against tumor suppressor gene mutations in NSCLC or SCLC.

Our Method for Treating Cancer

Using tumor suppressor genes expressed in a DNA plasmid, which are then encapsulated in non-viral lipid nanoparticles in a lipoplex form, we reintroduce tumor suppressor genes to patients systemically to specifically target cancer cells.

Oncology Platform

We believe that our ONCOPREX Delivery System may be applicable to delivery of a range of therapeutic and prophylactic plasmid DNA and RNA interference constructs and shows efficacy in cancers beyond lung cancer. We also believe that the manufacturing methods we have developed for REQORSA may be useful for a wide array of disease treatments. Clinical data from the use of REQORSA has shown that the ONCOPREX Delivery System is well tolerated in humans and can be delivered at high therapeutic doses.

Combination Therapies

Our lead oncology drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is initially being developed in combination with prominent, approved cancer drugs to treat non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

REQORSA also has been shown to be complementary with targeted drugs and immunotherapies. Our preclinical and clinical data indicate that REQORSA is well tolerated and may be effective alone or in combination with targeted small molecule therapies. Preclinical data indicate that REQORSA may also be effective with immunotherapies, and in a three-drug combination with immunotherapy and chemotherapy. These data suggest that REQORSA, when combined with other therapies, may be effective in a large population of lung cancer patients.

Our strategy is to develop REQORSA in combination with currently approved therapies, and we believe that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Addressing the Entire Lung Cancer Market

Targeting both NSCLC and SCLC allows Genprex to address virtually the entire lung cancer market. Approximately 82% of all NSCLCs and 100% of all SCLCs express decreased amounts of TUSC2 tumor suppressor protein. 

Lung Cancer

According to the World Health Organization in 2023, lung cancer was the leading cause of cancer deaths worldwide. According to the American Cancer Society in 2023, lung cancer accounts for about one in five of all cancer deaths in the United States, and causes more deaths in the U.S. with more people dying of lung cancer in the U.S. than of colon, breast and prostate cancers combined. In 2020, there were more than 2 million new lung cancer cases and approximately 1.8 million deaths from lung cancer worldwide. In the U.S., according to the American Cancer Society, it is estimated that in 2024 there will be more than 234,000 new cases of lung cancer and more than 125,000 deaths from this disease. NSCLC represents about 82% of all lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 9 percent. SCLC represents about 14% of lung cancer patients and the five-year survival rate for patients with SCLC with distant spread is 3 percent. 

With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC and SCLC in the U.S. and globally, and we believe REQORSA may be suitable for the majority of lung cancer patients.