On June 16, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron") (Press release, Genprex, JUN 16, 2020, View Source [SID1234561135]). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company’s manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.
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Genprex’s upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda) in NSCLC is also planned.
"We are pleased with continued progress in the scale-up of our manufacturing processes. This new agreement with Aldevron increases our manufacturing capabilities in support of our clinical trials utilizing Oncoprex immunogene therapy in combination with targeted therapies and immunotherapies against lung cancer," said Rodney Varner, Chairman and Chief Executive Officer of Genprex.
"Our team is excited about the expansion of our manufacturing agreement and elevation of our long-standing relationship with Genprex," said Michelle Berg, President of GMP Nucleic Acids at Aldevron. "Aldevron’s GMP facility and campus buildout ensures we can meet the future manufacturing demands of companies experiencing significant growth such as Genprex; thereby enabling our ultimate goal of impacting the lives of patients."
Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data indicate that the resultant product when transfected into cancer cells both induces cell signaling that triggers programmed cell death and modulates the immune system so that the cancer cells are more susceptible to treatment.