Genprex Inc. (NASDAQ: GNPX)
Genprex Inc. (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes. The company’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations 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 was founded in 2009 and is headquartered in Austin, Texas.
Genprex’s oncology pipeline aims to reprogram the course of cancer. The company is evaluating its proprietary, non-viral ONCOPREX®Nanoparticle Delivery System, believed to be the first systemic gene therapy delivery platform used for cancer in humans, in multiple clinical programs.
ONCOPREX uses plasmids containing tumor suppressor genes encapsulated within lipid nanoparticles. The resultant product is administered intravenously to the patient to re-express the deleted tumor suppressor genes, which are deleted early in the development of cancer.
REQORSA® Immunogene Therapy
The company’s lead product candidate, REQORSA® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for non-small cell lung cancer (NSCLC), and a third clinical trial for small cell lung cancer (SCLC) will open for enrollment in 2023. Notably, both of its NSCLC clinical programs received a Fast Track Designation from the U.S. Food and Drug Administration.
REQORSA consists of the TUSC2 gene (a tumor suppressor gene) expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge.
Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to be complementary with targeted drugs and immunotherapies.
Genprex’s R&D pipeline for REQORSA in NCSLC includes the Acclaim-1 phase I/II trial in combination with Tagrisso (osimertinib), the Acclaim-2 phase I/II trial in combination with Keytruda (pembrolizumab), the completed ONC-001 phase I dose escalation trial evaluating REQORSA as a monotherapy and the completed ONC-002 phase I trial in combination with Tarceva (erlotinib). In SCLC, Genprex is advancing the Acclaim-3 phase I/II trial in combination with Tecentriq (atezolizumab).
Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The candidates in Genprex’s pipeline have demonstrated potential to stabilize glucose levels and reduce insulin requirements in non-human primate studies.
The company’s R&D pipeline for diabetes includes its preclinical candidates, GPX-002 for Type 1 diabetes and GPX-003 for Type 2 diabetes.
The Market for Cancer and Diabetes
Genprex’s cancer-fighting technologies seek to bridge a critical gap by combining with targeted therapies and immunotherapies to provide treatments to large patient populations who have become resistant to them. Genprex technologies are being developed to overcome genomic limitations which are inherent in targeted therapies and immunotherapies in order to provide new treatment solutions to large cancer populations, such as those with lung cancer.
Each year, more people die of lung cancer than of colon, breast and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for about 82 percent of all lung cancers, according to the American Cancer Society (ACS). Despite radical advances in drug development and novel therapeutic standards, the five-year survival rate for patients with NSCLC with distant spread is 7%.
Developed resistance to leading drugs such as Tagrisso, Keytruda and Tecentriq is inevitable for most patients, putting the average five-year lung cancer survival rate at just 18.6% and highlighting the importance of REQORSA’s demonstrated potential to block the mechanisms that create drug resistance. In terms of healthcare spending, the global lung cancer market is projected to exceed $48.7 billion by 2026.
The diabetes market represents another serious need in the healthcare industry. Roughly 537 million people around the globe are living with diabetes – a figure that is expected to rise to 783 million by 2045. In the U.S., spending relating to Type 1 diabetes is expected to hit $20.3 billion by 2029, while Type 2 diabetes market sales in the U.S. are expected to climb to $57 billion by that same year.
Despite certain advancements in treatment, quality of life remains highly compromised for many with diabetes. Diabetes gene therapies like those being developed by Genprex could hold the potential to provide long-term effectiveness or change the course of the disease.
Chairman, President and Chief Executive Officer Rodney Varner, JD, is a co-founder of Genprex and has served in these roles since August 2012. He has more than 35 years of legal experience with large and small law firms and as outside general counsel of a Nasdaq-listed company. Mr. Varner has served as counsel in company formation, mergers and acquisitions, capital raising, other business transactions, protection of trade secrets and other intellectual property, real estate and business litigation. He is a member of the State Bar of Texas and has been admitted to practice before the U.S. Court of Appeals for the Fifth Court and the U.S. Tax Court.
Catherine M. Vaczy is the company’s Executive Vice President, General Counsel and Chief Strategy Officer and has served with the company for over three years. She has more than 20 years of experience as a founder and senior executive of life science companies, serving as a strategic partner and business and legal advisor to senior leadership teams and boards. Immediately prior to Genprex, Ms. Vaczy provided strategic advisory services to early-stage biotechnology companies. Prior to that, Ms. Vaczy co-founded and served for 10 years on the senior leadership team of NeoStem Inc., then a Nasdaq-listed clinical stage biotechnology company that combined a leading cell and gene therapy process development and manufacturing organization (sold to Hitachi Chemical) with a development pipeline of cell therapy products. Prior to NeoStem, Ms. Vaczy served as Vice President, Legal of ImClone Systems Incorporated, a pioneer in targeted cancer drug development. Ms. Vaczy received a BA degree from Boston College and a JD degree from St. John’s University School of Law.
Ryan M. Confer, MS, has served as Genprex’s Chief Financial Officer since September 2016. Mr. Confer has more than 10 years of executive experience in planning, launching, developing and growing emerging technology companies and has served in the chief operating and chief financial roles for non-profit and for-profit entities since 2008. Mr. Confer has also served as an international business development consultant for the University of Texas at Austin’s IC2 Institute, where he focused on evaluating the commercialization potential of nascent technologies in domestic and international markets applicable to technology incubator programs associated with the university. He holds a BS in finance and legal studies from Bloomsburg University of Pennsylvania and an MS in technology commercialization from the McCombs School of Business at the University of Texas at Austin.
Mark S. Berger, MD, is the company’s Chief Medical Officer. He is a senior executive with 25 years of biotech and pharmaceutical company experience in the development of oncology therapeutics. Prior to joining Genprex in September 2021, Dr. Berger served as Chief Medical Officer for Actinium Pharmaceuticals Inc., where he was responsible for clinical strategy and development of radioisotope-labeled antibodies for therapy in oncology. Before that, Dr. Berger was Senior Vice President-Clinical Research at Kadmon Corporation, where he led all aspects of the company’s new drug development, including clinical trial design and management of the oncology programs in non-small cell lung cancer and breast cancer, among others. Dr. Berger holds a B.A. in biology from Wesleyan University and an M.D. from the University of Virginia School of Medicine.
Hemant Kumar, Ph.D., CPM, EMBA is the company’s Chief Technology and Manufacturing Officer. Dr. Kumar is a recognized global expert in chemistry, manufacture and controls (CMC) technical development and GMP manufacturing. Prior to joining Genprex in September 2021, Dr. Kumar was Vice President, Global Head of Manufacturing, Supply Chain, and Strategy for Arcturus Therapeutics, Inc. Prior to that, Dr. Kumar was Vice President of CMC Technical Development & Manufacturing Operations at Oncoimmune Therapeutics, Inc., a private company that was acquired by Merck & Co. during his tenure there. Before that, he was Vice President, Head of Global Process Sciences and Clinical Manufacturing Operations at Rentscher BioPharma, SE. Dr. Kumar has held senior level positions of increasing manufacturing and technical operations leadership in global biopharmaceutical companies including Merck & Co., Inc., Sanofi Genzyme, Inc., Lonza Biologics, Inc., Sanofi Pasteur, Janssen Biotech (a Johnson & Johnson company) and Wyeth Lederle Vaccines, Inc. Dr. Kumar earned his Ph.D. in Biochemistry at J.N. Medical College, Aligarth India through a collaboration with the U.S. National Institute of Health. He holds a graduate certificate in Project Management from Lehigh University.