Genprex finishes production ramp up of REQORSA ahead of lung cancer clinical trials

Genprex Inc (NASDAQ:GNPX) has completed a manufacturing scale-up of its non-small cell lung cancer (NSCLC) immunogene therapy candidate REQORSA in advance of a pair of clinical trials, the company announced Tuesday. The production is expected to supply the upcoming Acclaim-1 and Acclaim-2 clinical NSCLC trials, subject to passing final testing that is currently underway. The trials will evaluate REQORSA in combination with AstraZeneca’s drug Tagrisso and Merck & Co’s Keytruda, and both are on track to be initiated in the first half of 2021. Earlier this month, Genprex completed the technology transfer of its REQORSA manufacturing process from the major cancer research institution where it was previously manufactured to commercial Contract Development and Manufacturing Organizations (CDMOs). READ: Genprex says successfully completes technology transfer of the manufacturing process for production of its REQORSA immunogene therapy For the first time, REQORSA was manufactured in a scaled-up clinical production in accordance with the current Good Manufacturing Practices (cGMP) required by the US Food and Drug Administration (FDA) in advance of commercial approval.  “The scaled-up production of clinical-grade REQORSA is yet another significant manufacturing milestone for the company,” COO Michael Redman said in a statement. “Utilizing advanced processes, we were able to successfully improve our production yield multi-fold with significantly improved economies of scale.” Upon completion of testing and lot release, REQORSA will be transported to cold storage depots, which will facilitate shipments to clinical trial sites following FDA clearance. Unlike some biologicals that require shipment and storage at -80 degrees Celsius, REQORSA requires storage at only 2-8 degrees Celsius, the company said. REQORSA consists of TUSC2 plasmid DNA encapsulated in non-viral nanoparticles that are administered intravenously and designed to target tumor cells. The ramp up in production will also help Genprex address the broader lung cancer market, the company said. “This achievement positions Genprex with the manufacturing capability for potential future commercialization in the rapidly growing lung cancer therapeutics market, which is projected to grow to $26.3 billion by 2023,” Redman said.  Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel