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%).
[NLINSERT]Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
