When companies see their shares rise by 100% or more in a single day, it’s usually because of a buyout or an extremely positive change in a company’s future prospects. For Genprex Inc. (NASDAQ: GNPX), all it took was the U.S. Food and Drug Administration (FDA) to issue a Fast Track Designation for the company’s gene therapy treatment that is targeting lung cancer.

Investors need to understand that, while lung cancer is a huge opportunity, Genprex is a micro-cap stock that is not worth $50 million, even after its monumental gain on Tuesday. The company also very recently had a small capital raise of about $200,000 and its “use of proceeds” was shown to be for working capital and other general corporate purposes.

Genprex announced on Tuesday that the FDA issued a Fast Track Designation for the company’s use of tumor suppressor genes to cancer cells for its Oncoprex immunogene therapy in combination with EGFR inhibitor osimertinib from AstraZeneca.

While a Fast Track is not an outright approval, the excitement here is that the press release showed that AstraZeneca’s Tagrisso was shown to have global sales of $1.86 billion in 2018 and that sales had reached $2.31 billion in just the first nine months of 2019. The treatment is also shown to be AstraZeneca’s highest selling product. Its target is to treat non-small cell lung cancer (NSCLC) patients with EFGR mutations who have progressed after treatment with osimertinib alone. The press release also indicated that Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle.

As for the treatment, lung cancer is generally considered to be the world’s number-one cause of cancer deaths, with over 2 million new cases and about 1.7 million deaths per year. Genprex showed that this is a higher number of deaths than from colon cancer, breast cancer and prostate cancer combined. In the United States alone, the figures are closer to 228,000 new lung cancer cases and over 142,000 deaths per year attributed to lung cancer. In the target group, NSCLC is shown to represent some 84% of all lung cancers, with a five-year relative survival rate for metastatic lung cancer being less than 5%.

This has yet to be tested with results from a very large pool of candidates. Genprex said that it has treated more than 50 lung cancer patients with Oncoprex in Phase 1 and 2 clinical trials and that the data are encouraging on safety and efficacy. Genprex also still has a long road ahead of it. The company is preparing to begin a Phase 1/2 clinical trial evaluating Oncoprex in combination with osimertinib, and it is preparing to begin a new Phase 1 clinical trial evaluating Oncoprex in combination with a checkpoint inhibitor.

As for what the FDA Fast Track Designation can mean for a company, it can create an expedited review by the FDA and can be approved quicker than other traditional FDA reviews. For the drug or treatment to qualify, it must demonstrate the potential to address unmet medical needs for a serious or life-threatening disease or condition, and the treatments must show advantages over available therapies (superior effectiveness, fewer side effects, superior diagnosis and outcome, lower toxicity, or address public health needs). Fast Track designations also come with an accelerated approval or rolling review of a company’s Biologics License Application (BLA), and they can be eligible for priority review if supported by clinical data at the time of BLA submission.

The long and short of the matter, if all goes well, is that a Fast Track can lead to a much faster approval at a lower cost than traditional FDA approvals.

Rodney Varner, chair and chief executive officer of Genprex, said of the news:

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.

Genprex shares surged by nearly 300% at $1.43 shortly after Tuesday’s opening bell. Its prior close was $0.36, and it has a 52-week trading range of $0.23 to $2.26. Even after this exponential gain, it has a mere $26 million market cap.

The only analyst call that has been seen on this company was an Outperform rating and $5.00 target issued by Noble Financial back in April of 2019.

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