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Genprex Appoints William E. Gannon, Jr., MD, MBA, as Vice President of Regulatory Affairs

September 2, 2020 Off By BusinessWire

Dr. Gannon will oversee and manage regulatory matters for the Company’s upcoming clinical trials, including its lead drug candidate in combination with Tagrisso® for which Fast Track Designation was received earlier this year

AUSTIN, Texas–(BUSINESS WIRE)–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, today announced the appointment of William Gannon, MD, MBA as the Company’s Vice President of Regulatory Affairs. Dr. Gannon brings more than 30 years of experience in the biotech and pharmaceutical industries to the Company, with expertise in clinical development, regulatory affairs and commercialization of products, and a strong background in oncology and gene therapy.

“We are pleased to have Dr. Gannon join our team. His extensive experience in the management of clinical trials, from designing trials to building operational teams, will be an important asset for us as we work toward initiating our upcoming trials and seeing them through to successful completion,” said Rodney Varner, Genprex’s Chairman and Chief Executive Officer.

Dr. Gannon will be responsible for managing the Company’s regulatory affairs for its upcoming clinical trials that combine its lead drug candidate, GPX-001 for non-small cell lung cancer (NSCLC), with AstraZeneca’s targeted therapy Tagrisso® (osimertinib) and with immunotherapy Keytruda® (pembrolizumab). Genprex received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for use of GPX-001 in combination with Tagrisso in late-stage lung cancer patients with EGFR mutations whose tumors progress on Tagrisso. Alongside his responsibility of advising on regulatory matters, Dr. Gannon will also serve as the Medical Monitor, interfacing with medical personnel at trial sites and assisting with FDA communication throughout the clinical trials.

Dr. (Read more…) Gannon currently serves as Chief Scientific Officer and Medical Director at Capital City Technical Consulting, where he has led clinical trial development and operations management for various clients across the biotech and pharmaceutical industries and through which he will carry out his new Genprex role. Prior to Capital City, Dr. Gannon served as Vice President of Clinical and Medical Affairs for Celsion Corporation, an oncology biotech and medical device firm, where he led its clinical trial development and operations, data management, regulatory affairs and FDA submissions. He has held several executive roles at various biotech, pharmaceutical and medical device companies, overseeing regulatory affairs, both U.S. and international, for filings, meetings, submissions and approvals.

He has served on the Institutional Review Board (IRB), Board of Directors and Clinical Advisory Board of several organizations and is an active member of research and professional affiliations, including the AdvaMed (Advance Medical Technology Association), the Drug Information Association, the Regulatory Affairs Professional Society and the American Academy of Pharmaceutical Physicians and Investigators.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options 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.

Forward-Looking Statements

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.