Genprex Completes Manufacturing Technology Transfer for Novel Gene Therapy
December 8, 2020
Successful Completion of Engineering Batch with Transfer from Research Institution to Commercial Contract Development and Manufacturing Organizations with Clinical Production Underway
Manufacturing Technology Transfer Marks Major Company Milestone
AUSTIN, Texas — (December 8, 2020) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has successfully 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).
The completed technology transfer marks a significant achievement for Genprex. 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 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 & 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, President and Chief Executive Officer of Genprex. “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. 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.
About Genprex, Inc.
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. In January 2020, the U.S. 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.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of REQORSA™ immunogene therapy drug, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of REQORSA and our other potential product candidates including whether we receive or benefit from fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.