On January 22, 2020 Genprex Inc (NASDAQ:GNPX) reported that the US Food and Drug Administration has granted Fast Track Designation for its Oncoprex immunogene therapy to treat lung cancer (Press release, Genprex, JAN 22, 2020, View Source [SID1234553519]).
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Investors cheered the news, pushing the company’s stock up by 276% to $1.35 a share in recent morning trading in New York.
The FDA gave its approval to the therapy combination with EGFR inhibitor osimertinib — AstraZeneca PLC’s (NYSE:AZN) Tagrisso. The drug had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first nine 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 said it 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 Genprex CEO Rodney Varner.