December 8, 2020 -- Genprex said that it has completed the technology transfer of the manufacturing process for its Reqorsa lead immunogene therapy candidate to commercial contract development and manufacturing organizations.
The manufacturing technology was transferred from a cancer research institution where Reqorsa was discovered and had previously been manufactured. It has now been manufactured at commercial scale in a current good manufacturing practices-compliant facility for the first time, according to Genprex.
Reqorsa is comprised of a tumor suppressor candidate 2 (TUSC2) plasmid DNA that's encapsulated in nonviral nanoparticles that are administered intravenously and designed to target tumor cells.
The firm said it believes production and process improvements will result in a scalable, reproducible, and stable drug product suitable for storage, shipment, and patient use. In addition, Genprex also believes it's on track to complete manufacturing of clinical-grade Reqorsa to supply the company's upcoming Acclaim-1 and Acclaim-2 clinical trials. These trials, which will combine Reqorsa with, respectively, AstraZeneca's Tagrisso and Merck's Keytruda drugs, are expected to begin in the first half of 2021.