Genprex's shares spiked 380% higher in morning trading as the company reported that the FDA granted Fast Track Designation for its Oncoprex immunogene therapy in combination with EGFR inhibitor osimertinib.
This morning, Genprex Inc. (GNPX:NASDAQ), which "utilizes a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells," announced that "the U.S Food and Drug Administration (FDA) has granted Fast Track Designation for Genprex's Oncoprex™ immunogene therapy in combination with epidermal growth factor receptor (EGFR) inhibitor osimertinib (AstraZeneca's Tagrisso®)" for the treatment of non-small cell lung cancer (NSCLC). According to the report, Tagrisso is AstraZeneca Plc's (AZN:NYSE) highest grossing product, which had $2.31 billion in sales worldwide during the first nine months of 2019. The company reported that Oncoprex is composed of the active agent Tumor Suppressor Candidate 2 (TUSC2) gene complexed with a lipid nanoparticle.
The firm advised that it has already treated more than 50 lung cancer patients in total with Oncoprex in both phase 1 and phase 2 clinical trials and believes the trial data results are encouraging as to safety and efficacy. Genprex further indicated that it is currently preparing to initiate a phase 1/2 clinical trial in order to evaluate Oncoprex in combination with osimertinib and also a separate new phase 1 clinical trial evaluating Oncoprex in combination with a checkpoint inhibitor.
The company's Chairman and CEO Rodney Varner commented, "Genprex is excited to receive this important FDA designation...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."
The firm explained "the 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 and that the 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."
The company stated that the initial disease indication for Oncoprex is non-small cell lung cancer and advised that "lung cancer is the world's leading cause of cancer death, taking more lives each year than colon, breast and prostate cancers combined."
Genprex is a clinical-stage gene therapy company headquartered in Austin, Tex., that develops technologies for cancer patients using its proprietary technology platform. The company stated that "its lead product candidate, Oncopre immunogene therapy for NSCLC, has a multimodal mechanism of action whereby it has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells, re-establish pathways for apoptosis, or programmed cell death, in cancer cells, and modulate the immune response against cancer cells."
Genprex began the day with a market capitalization of around $6.9 million with approximately 19.26 million shares outstanding. GNPX shares opened more than 230% higher today at $1.20 (+$0.84, +233.33%) compared to Friday's $0.36 closing price. The stock has traded today on extremely high volume between $1.04 and $1.74 per share and is presently trading at $1.23 (+$0.87, +241.67%).
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