8 December 2020 - - US-based gene therapy company Genprex, Inc. (NASDAQ: GNPX) has completed the technology transfer of its manufacturing process for the production of Reqorsa immunogene therapy, the company's lead drug candidate, from the major cancer research institution where it was previously manufactured to experienced, commercial Contract Development and Manufacturing Organizations (CDMOs).

For the first time, Reqorsa was manufactured at commercial scale in a current Good Manufacturing Practices compliant facility, outside of the research institution where Reqorsa was discovered.

The company believes production and process improvements will result in a reliable, scalable, reproducible and stable drug product suitable for storage, shipment and patient use.

The company believes that it is on track to complete manufacturing of clinical grade Reqorsa to supply the company's upcoming Acclaim-1 and Acclaim-2 clinical trials that combine Reqorsa with Tagrisso (marketed by AstraZeneca) and with Keytruda (marketed by Merck and Co., Inc.), respectively, both of which are on track to be initiated in the first-half 2021.

All components of the manufacturing processes, including the final drug product, have been manufactured at commercial CDMOs.

Furthermore, Genprex's engineering run met all specifications.

Reqorsa is comprised of TUSC2 plasmid DNA (the active agent in REQORSA) encapsulated in non-viral nanoparticles that are administered intravenously and designed to target tumor cells.

Earlier this year, Genprex announced an agreement with Aldevron, LLC to manufacture the TUSC2 plasmid DNA used in Reqorsa.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.

Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.

Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.

The company's lead product candidate, Reqorsa (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC).

Reqorsa has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells.

Reqorsa has also been shown to block mechanisms that create drug resistance, the company said.

In January 2020, the US Food and Drug Administration granted Fast Track Designation for Reqorsa for NSCLC in combination therapy with osimertinib (AstraZeneca's Tagrisso) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone.