Genprex Announces Formation of Clinical Advisory Board
World reknowned medical and clinical experts to guide Genprex’ novel gene therapy clinical development programs in cancer and diabetes, including its two upcoming clinical trials in lung cancer
AUSTIN, Texas--(BUSINESS WIRE)--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, today announced the formation of a Clinical Advisory Board (CAB) to support its oncology and diabetes development programs. Comprised of preeminent clinical specialists, the CAB will lead and advise Genprex as it advances its REQORSA™ immunogene therapy program, including its Acclaim clinical trials in non-small cell lung cancer, and its preclinical diabetes gene therapy program. Some of the members also serve in additional roles at the Company.
“We are pleased to bring together this group of seasoned practitioners in the field of oncology and diabetes to guide and advise Genprex in advancing our clinical development programs,” said Genprex’s Chief Executive Officer, Rodney Varner. “The Clinical Advisory Board’s experience in clinical trials of cancer and diabetes therapies, combined with their expertise in consulting with small and large biotechnology companies, is invaluable as our drug candidates progress into the clinic.”
The members of Genprex’ Clinical Advisory Board include:
- Michael Morse, MD, MHS, FACP – Dr. Morse is a Professor of Medicine in the Division of Medical Oncology and Professor in the Department of Surgery at Duke University Medical Center, Durham, NC. His clinical expertise includes management of gastrointestinal malignancies including colon, hepatobiliary, gastroesophageal and pancreatic cancer. His research expertise includes the development of targeted therapies including immunotherapies for cancer. He has published extensively on topics in cancer immunotherapy, targeted therapies and gastrointestinal malignancies, including textbooks on Cancer Vaccines and Liver Tumors. Dr. Morse is Editor for Current Opinions in Biologic Therapies. He has been the principal investigator of a number of investigator-initiated and industry-supported phase 1 and 2 clinical trials of cancer immunotherapy and therapies for gastrointestinal malignancies. He is a member of the American Association of Cancer Research, the American Society of Clinical Oncology, the American Society for Clinical Investigation, American College of Physicians, and the Society for the Immunotherapy of Cancer.
- Col. George E. Peoples, MD, FACS– Dr. Peoples served 30 years of active duty as a surgeon and research scientist in the military. He is the Founder and Director of the Cancer Vaccine Development Program (CVDP), which has been focused on the discovery, development, and clinical testing of cancer vaccines for more than 20 years. Four of the program’s cancer vaccines have been licensed for commercial development. Dr. Peoples currently serves as the CEO of Cancer Insight, LLC, CVDP’s commercial counterpart, which is a boutique cancer immunotherapy Contract Research Organization conducting multiple Phase 1 and 2 clinical trials. He also serves as Professor of Surgery at the Uniformed Services University of the Health Sciences and Professor (adjunct) of Surgical Oncology at MD Anderson Cancer Center (MDACC). Dr. Peoples is the past Chair of the Cancer Care Program, San Antonio Military Medical Center and the past Military Director of the United States Military Cancer Institute. He is a graduate of the United States Military Academy, West Point and the Johns Hopkins School of Medicine. Dr. Peoples completed his surgical training at Harvard’s Brigham and Women’s Hospital and a surgical oncology fellowship at MDACC.
- Andrew B. Becker, MD, PhD – Dr. Becker is President and Founder of Becker Pharmaceutical Consulting, a market research, competitive intelligence and strategic planning consulting firm that provides analytic and strategy services to companies ranging from small biotechnology and medical device companies up to large multinational pharmaceutical companies on a global basis. Dr. Becker received both his medical degree and PhD in Molecular Pharmacology from Stanford University. At Stanford, Dr. Becker's research focused on signaling pathways for the insulin and IGF–1 receptors, deciphering the structure and function of the insulin degrading enzyme and its role in insulin processing.
- William E. Gannon, Jr., MD, MBA– Dr. Gannon serves as Genprex’s Vice President of Regulatory Affairs. He is responsible for managing the Company’s regulatory affairs for its upcoming clinical trials. He also will serve as the Medical Monitor, interfacing with medical personnel at trial sites and assisting with FDA communication throughout the clinical trials. Dr. Gannon has more than 30 years of experience in the biotech and pharmaceutical industries, with expertise in clinical development, regulatory affairs and commercialization of products, and a strong background in oncology and gene therapy.
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, 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 any FDA approvals of REQORSA and our other potential product candidates including whether we receive necessary approvals to commence clinical trials 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.
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