Genprex, Inc. (NASDAQ:GNPX) said it has successfully completed the technology transfer of its manufacturing process for the production of its REQORSA immunogene therapy from the major cancer research institution where it was previously manufactured to experienced, commercial Contract Development and Manufacturing Organizations (CDMOs).
The clinical-stage gene therapy company, which is focused on developing life-changing therapies for patients with cancer and diabetes, said the completed technology transfer marks a significant achievement for it.
For the first time, REQORSA was manufactured at commercial scale in a current Good Manufacturing Practices (cGMP) compliant facility, outside of the research institution where it was discovered.
The company said it believes production and process improvements will result in a reliable, scalable, reproducible and stable drug product suitable for storage, shipment and patient use.
Genprex added that it 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 & Co., Inc.), respectively, both of which are on track to be initiated in the first-half 2021.
“The successful completion of our manufacturing technology transfer represents a major milestone for Genprex,” said Rodney Varner, the company's president and chief executive officer in a statement.
“We are delighted to collaborate with leading, global CDMOs that have enabled us to complete the successful engineering batch. We are now focused on the completion of commercial-scale production of REQORSA, for use in our two upcoming clinical trials. At the same time, our clinical group is engaging with clinical trial sites who will recruit and treat patients related to our clinical trials.”
All components of the manufacturing processes, including the final drug product, have been manufactured at commercial CDMOs, the company said, furthermore, Genprex’s engineering run met all specifications.
The company’s lead product candidate, 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.
REQORSA (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). It 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.
In January 2020, the US Food and Drug Administration (FDA) 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.
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. The company 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.
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