Shares of thinly-traded gene therapy company Genprex Inc (NASDAQ: GNPX) are soaring on more than 50 times their average volume Tuesday.
Genprex, which uses a non-viral, proprietary platform to deliver tumor suppressor genes to cancer cells, said the FDA has granted Fast Track Designation to its Oncoprex immunogene therapy in combination with AstraZeneca plc's (NYSE: AZN) Tagrisso, for the treatment of non-small cell lung cancer, or NSCLC.
Oncoprex consists of tumor suppressor candidate 2, or TUSC2, gene, complexed with a lipid nanoparticle, the company said in the release.
Why It's Important
Fast Track Designation is accorded to experimental drugs that possess the potential to address unmet medical needs for a serious or life-threatening disease or condition. This provision makes the candidate eligible for accelerated approval or rolling review of its BLA as well as priority review, provided clinical data supports it at the time of BLA submission.
NSCLC represents about 84% of all lung cancers, with five-year relative survival rate for metastatic lung cancer at less than 5%, the company said, citing estimates. In the U.S., more than 228,000 new cases of lung cancer are reported every year and over 142,000 deaths occur.
Genprex said it's planning to initiate a Phase 1/2 clinical trial to evaluate Oncoprex in combination with Tagrisso as well as a new Phase 1 trial to evaluate it in combination with a checkpoint inhibitor.
Genprex's stock was skyrocketing 261% to $1.30 per share at time of publication.