Promotion follows the Company’s achievement of key manufacturing milestones to support upcoming clinical trials
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 the promotion of Eric Chapdelaine to Vice President of Manufacturing. Mr. Chapdelaine’s promotion is a result of the Company’s achievement of key manufacturing milestones to support upcoming clinical trials of the Company’s lead drug candidate, GPX-001 (quaratusugene ozeplasmid). Upcoming trials include a Phase I/II trial combining GPX-001 with AstraZeneca’s Tagrisso® (osimertinib) in non-small cell lung cancer (NSCLC) patients who progressed on Tagrisso, which received U.S. Food and Drug Administration (FDA) Fast Track Designation in January 2020.
"The appointment of Eric to our senior team is a hallmark of our manufacturing achievements and highlights the progress we have made in scaling up our manufacturing to commercial scale, which will further supply our upcoming clinical trials," said Michael Redman, Genprex’s Executive Vice President and Chief Operating Officer.
In June of 2020, Genprex announced the expansion of its commercial development program for the manufacture of TUSC2 (Tumor Supressor Candidate 2) plasmid DNA, the active agent in GPX-001. The program expansion provides for full commercial scale plasmid DNA manufacturing with a key manufacturing partner. This relationship is supporting the manufacture of the drug product, GPX-001, to supply the Company’s upcoming clinical trials in which GPX-001 is combined with Tagrisso and Keytruda® (marketed by Merck), respectively.
Mr. Chapdelaine has more than 15 years of experience in the pharmaceutical and biotech industries. He joined Genprex in 2019 as Senior Director of Pharmaceutical Sciences and Manufacturing, where he has been responsible for leading the Company’s Manufacturing Operations and Supply Chain functions. Prior to joining Genprex, Mr. Chapdelaine was Director of Quality Control and Analytical Development at Cognate BioServices, responsible for management and oversight of a large Quality Control and Analytical Development staff and multiple laboratories in a Cell and Gene Therapy CDMO facility. Prior to Cognate, he served as Quality Control Manager of Specifications at Alnylam Pharmaceuticals, where he led as Specification Committee Chairperson and authored CMC-related sections of regulatory filings for the first ever approved RNAi therapeutic for commercial use. Mr. Chapdelaine spent the prior six years at Sanofi Genzyme.
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, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 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. GPX-001 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 GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.
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 GPX-001, 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 GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. 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.
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