GNPX stock closed up more than 20% in after-hours trading on January 21, 2020, after the company announced that the FDA assigned Genprex’s Oncoprex, Fast Track Designation.

Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, today announced that the U.S Food and Drug Administration (FDA) has granted Fast Track Designation for Genprex’s Oncoprex™ immunogene therapy in combination with EGFR inhibitor osimertinib (AstraZeneca’s Tagrisso®, which had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first 9 months of 2019 and is currently AstraZeneca’s highest grossing product) for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone. Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle. TUSC2 is the active agent in Oncoprex.

Genprex has treated more than 50 lung cancer patients with Oncoprex in Phase I and II clinical trials. The company believes the data from these trials are encouraging as to both safety and efficacy.

“Genprex is excited to receive this important FDA designation,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment.”

FDA may award Fast Track Designation if it determines that a drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

Fast Track drug candidates must show advantages over available therapies, such as superior effectiveness, avoiding serious side effects, improving diagnosis and outcome, decreasing significant toxicity, and the ability to address public health needs.

Fast Track Designation recipients may also be eligible for accelerated approval or rolling review of the recipient’s Biologics License Application (BLA). In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.

The initial disease indication for Oncoprex is NSCLC. Lung cancer is the world’s leading cause of cancer death, taking more lives each year than colon, breast and prostate cancers combined. Each year, there are more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide. In the United States, there are more than 228,000 new cases of lung cancer and more than 142,000 deaths from lung cancer each year. NSCLC represents 84 percent of all lung cancers, and the five-year relative survival rate for metastatic lung cancer is less than 5 percent.

Genprex is preparing to initiate a Phase I/II clinical trial evaluating Oncoprex in combination with osimertinib, as well as a new Phase I clinical trial evaluating Oncoprex in combination with a checkpoint inhibitor.

Back on November 19, 2019, Genprex (NASDAQ: GNPX) reported that its collaborators from The University of Texas MD Anderson Cancer Center (“MD Anderson”) presented positive preclinical data for the combination of TUSC2 immunogene therapy with an anti-PD1 antibody, pembrolizumab, and for the combination of TUSC2 immunogene therapy, pembrolizumab, and chemotherapy for the treatment of some of the most resistant metastatic lung cancers, including the KRAS and LKB1 mutations, at the American Association of Cancer Research Tumor Immunology and Immunotherapy Meeting 2019. The TUSC2 gene is a tumor suppressor gene and is the active agent in Genprex’s Oncoprex™ immunogene therapy.

  • Company’s TUSC2 gene therapy found to increase effectiveness of anti-PD1 immunotherapy and anti-PD1 immunotherapy combined with platinum chemotherapy in humanized mouse model
  • TUSC2 in combination with anti-PD1 and chemotherapy resulted in complete eradication of anti-PD1 resistant lung metastases
  • Company’s Oncoprex™ immunogene therapy may improve on first-line standard of care for lung cancer

The poster, entitled “Efficacy of Novel Immunogene-Combinations for KRAS and LKB1 mutant NSCLC in a Humanized Mouse Model” shows that TUSC2 confers sensitivity to checkpoint blockade for some of the most resistant metastatic human cancers, including the KRAS and LKB1 mutations, in mice with human immune cells (humanized mice) with lung metastases. When TUSC2 was combined with anti-PD1 therapy, pembrolizumab, in humanized mice with KRAS and LKB1 lung metastases, there was significantly increased antitumor activity than when compared to either agent alone. This combination and model also demonstrated TUSC2-related NK (Natural Killer) cell activation. A significantly higher percentage of CD56+ NK and CD56+CD59+ active NK cells, which are immune cells that have been activated to kill cancer cells, were found in the mice that received TUSC2 alone and in those that received the combination of TUSC2 and pembrolizumab than in those that received pembrolizumab alone.

The poster also shows that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with platinum chemotherapy in humanized mice with lung metastases with KRAS and LKB1 mutations, thus demonstrating that TUSC2 may improve on first-line standard of care for lung cancer. The combination of TUSC2 with pembrolizumab and carboplatin, a platinum chemotherapy, in humanized mice with KRAS and LKB1 lung metastases resulted in metastasis regression significantly greater than either TUSC2 alone or pembrolizumab combined with carboplatin treatments. This model showed significantly fewer or no visible tumor nodules after treatment with the TUSC2 combination as compared with other groups, and it showed strong antitumor efficacy. The combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in the humanized mouse model.

“These data not only further support existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy, but they also offer new data demonstrating that Oncoprex improves on the combination of anti-PD1 therapy and chemotherapy, today’s first line standard of care for lung cancer,” said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. “In a sophisticated humanized mouse model, the combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in some of the most resistant cancer mutations. This is highly encouraging and provides us with a strong indication that the combination could lead to similar results in the clinic.”

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