The Projected $26.3 Billion Non-Small Cell Lung Cancer Treatment Market Could Have a Transformational Year(1)
With FDA Fast Track Approval, Genprex Inc. (NASDAQ:GNPX) Aims to Treat the Most Common Form of Lung Cancer as It Nears Two Clinical Trials
Did you know that lung cancer is the world’s leading cause of cancer deaths?(2)
The death counts of breast, colon, kidney, liver, prostate, and skin cancer all seem to pale in comparison. Each year, there are more than approximately two million lung cancer diagnoses, with about 1.7 million deaths.(2)
Plus, according to the National Cancer Institute, around 57% of lung cancer diagnoses “are distant, or have metastasized, and the five-year survival rate for distant diagnoses is approximately 5 percent.”(2)
But out of all forms of lung cancer, the majority of cases appear to be non-small cell lung cancer (NSCLC). This condition makes up about 84% of overall lung cancer cases, and it could have an estimated five-year relative survival rate of 24%.(2)
Not to mention, with such an unmet medical need, this market could potentially grow to roughly $26.3 billion by 2023.(2)
It’s a dire condition, and for me personally, it hits close to home. However, there is hope.
Several companies may be nearing a treatment. But with two clinical trials for NSCLC treatment in 2021, coupled with a U.S. FDA Fast Track Designation, pharma company Genprex (NASDAQ:GNPX) looks as promising as any.
Bulls Should Pay Attention to Genprex Inc.’s (NASDAQ:GNPX) Momentum and Technicals
The Genprex stock has had an eventful 2021 thus far. After breaking out from its year-to-date low of approximately $3.51, Genprex Inc. found an initial peak of around $7.72- suitable for a strong return of roughly 119.94%. However, when the market saw a downturn at the end of February, the stock pulled back to a low of about $4.32. Yet, since then, the stock reversed and advanced about 16.9% to approximately $5.05. From here, the stock could have the potential to retest those peaks from the last month-especially with a good deal of excitement about its cancer treatments.
Also, the stock is displaying bullish indicators, including its 20 – 50 Day MACD Oscillator, 20 – 100 Day MACD Oscillator, 20 – 200 Day MACD Oscillator, 50 Day Moving Average, 50 – 100 Day MACD Oscillator, 50 – 150 Day MACD Oscillator, 50 – 200 Day MACD Oscillator, 100 Day Moving Average, 150 Day Moving Average, 200 Day Moving Average, and 100 – 200 Day MACD Oscillator.(8)
Plus, let’s take a look for comparison’s sake at how the stock’s valuation compares to its peers. Judging from this graphic, the stock could be significantly undervalued.
Why Pay Attention to Genprex Inc. (NASDAQ:GNPX)
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.
The company is harnessing the power of breakthroughs in lung cancer treatment, using cutting-edge technology and research to bring potentially life-changing therapies to patients.
In fact, its lead drug candidate, REQORSA immunogene therapy, is initially targeting non-small cell lung cancer (NSCLC). REQORSA utilizes a unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System combined with approved targeted therapies and immunotherapies, such as Tagrisso and Key-tru-da.
The Company’s Acclaim-1 and Acclaim-2 clinical trials, which combine REQORSA with Tagrisso and Key-tru-da, respectively, could be on track to be initiated in the first half of 2021.
But most importantly? Its Acclaim-1 trial already has FDA Fast Track Approval.
More on the Acclaim Trials
Acclaim-1 plans to combine REQORSA with Tagrisso, AstraZeneca’s highest grossing product with approximately $3 billion in worldwide sales during the first nine months of 2020.(4)
This trial will be an open-label, multi-center Phase 1/2 clinical trial using REQORSA combined with Tagrisso in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. The trial is expected to be conducted at approximately 10 U.S. clinical sites and enroll around 100 patients (9-18 patients in the Phase 1 component and 82 patients in the Phase 2 component). An interim analysis will be performed after 53 events (i.e., disease progression or death).
The primary endpoint of the Phase 1 component of the trial is dose-limiting toxicity. The primary endpoint of the Phase 2 component of the trial is progression-free survival compared with Tagrisso monotherapy.
Acclaim-2 plans combine REQORSA with Key-tru-da, Merck’s highest grossing product with approximately $10 billion in worldwide sales in the first nine months of 2020.(4)
This trial will be a Phase 1/2 clinical trial using REQORSA combined with Key-tru-da in NSCLC patients who are low expressors (1% to 49%) of the protein programmed death-ligand 1.
Going forward, the company expects to:
- Dose the first patient in each of the clinical trials.
- Announce interim data from the clinical trials.
- Report pre-clinical data related to its sponsored research agreement with a major cancer research center and from the ongoing pre-clinical studies of GPX-002 with the University of Pittsburgh.
- Explore new cancer indications and expand its pipeline.
- Pursue pharmaceutical partnerships and collaborate with partners.
- Expand and strengthen its global IP portfolio.
Strong Management, Strong Results – (NASDAQ:GNPX)
A powerhouse team of experts is leading Genprex Inc. (NASDAQ:GNPX) on its hopeful path to clinical success and revolutionary treatments to solve an unmet medical need.
President & Chief Executive Officer
Rodney Varner is a co-founder of Genprex and has served as our President, Chief Executive Officer, Secretary, and chairman of our board of directors since August 2012. Mr. Varner has served as a partner of the law firm Wilson & Varner, LLP, since 1991. Mr. Varner has more than thirty-five years of legal experience with large and small law firms and outside general counsel of a Nasdaq-listed company. Mr. Varner has represented for-profit and non-profit companies at the board of directors or senior management levels in a wide variety of contractual, business, tax, and securities matters, including technology transfers, licensing, collaboration and research agreements, clinical trial contracts, pharmaceutical, and biologics manufacturing and process development contracts, state and federal grants, including NIH and SBA grants, corporate governance and fiduciary issues, and real estate matters.
Vice President of Manufacturing
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. Before joining Genprex, Mr. Chapdelaine was Director of Quality Control and Analytical Development at Cognate BioServices, responsible for management and oversight of an extensive Quality Control and Analytical Development staff and multiple laboratories in a Cell and Gene Therapy CDMO facility. Before 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.
Director of Clinical Trials
Kate Combs joined Genprex as the Director of Clinical Trials in October 2020, where she is responsible for the management and oversight of all operational aspects of clinical trial implementation. Ms. Combs brings more than 10 years of clinical operations experience in various general medicine and oncology indications from both the CRO and biotech industries. Before joining Genprex, she spent three years working in clinical project management for Cell Medica (now Kuur Therapeutics) on multiple global, early-phase, cell therapy, oncology trials. She has held other clinical management and operations roles for Mirna Therapeutics, PPD, INC Research (now Syneos Health), and ICON. Ms. Combs began her career in clinical operations as a Clinical Research Associate for Lexicon Pharmaceuticals. Ms. Combs holds a BS in biomedical science from Texas A&M University, and she is a Registered Nurse.
Ryan M. Confer, MS
Chief Financial Officer
Ryan M. Confer, MS, has served as our Chief Financial Officer since September 2016. From December 2013 through September 2016, he served as our Chief Operating and Financial Officer, and from June 2011 to December 2013, as our business manager. Mr. Confer has aided the company in a variety of strategic, operations, and finance capacities since our inception in 2009, both as a consultant through his own firm, Confer Capital, Inc., and as an employee.
Mr. Confer has more than ten years of entrepreneurial experience in planning, launching, developing, and growing emerging technology companies. He has served in c-level and vice president roles for a variety of early-stage technology companies since 2008. Most notably, Mr. Confer served as VP of Customer Experience and then later as VP of Strategy for KaiNexus, Inc., an emerging technology company that develops continuous improvement software.
Senior Manager of Communications and Marketing
Kalyn Dabbs joins Genprex as Senior Manager of Communications and Marketing. Kalyn is responsible for developing and implementing internal and external communication and marketing plans, managing the company’s website and social media strategy, drafting and updating communication materials, and providing organizational leadership on communication and marketing initiatives.
Thomas Gallagher, Esq.
Senior Vice President of Intellectual Property & Licensing
Thomas C. Gallagher, Esq. joined Genprex as the Company’s Senior Vice President of Intellectual Property and Licensing. Mr. Gallagher has extensive experience in biotechnology intellectual property (IP) law, business development, and licensing transactions with industry and academic institutions. He also has more than 20 years of experience as an intellectual property attorney.
William E. Gannon, Jr., MD, MBA
Vice President of Regulatory Affairs
William Gannon, MD, MBA, joins Genprex 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 the commercialization of products. He also has a strong background in oncology and gene therapy.
Dr. Gannon is responsible for managing the company’s regulatory affairs for its upcoming clinical trials, and he also serves as the Medical Monitor, interfacing with medical personnel at trial sites and assisting with FDA communication throughout the clinical trials.
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 (Advanced Medical Technology Association), the Drug Information Association, the Regulatory Affairs Professional Society and the American Academy of Pharmaceutical Physicians and Investigators.
Vice President of Global Clinical Operations
Shannon joined Genprex as Vice President of Clinical Operations in April 2020, where she is responsible for defining clinical developmental strategies, clinical protocol design, study conduct, and managing risk assessment. She brings more than 20 years of experience to the company leading international clinical operations at biotechnology companies and research institutions.
Michael T. Redman
Executive Vice President & Chief Operating Officer
Mr. Redman brings more than 30 years of experience in the life sciences industry to Genprex. He has held various key executive roles at clinical-stage companies, focusing on strategic business development and the U.S. and worldwide manufacturing and clinical operations. He has also been instrumental in the consummation of multiple strategic transactions in the biotechnology and pharmaceutical industries.
Catherine M. Vaczy
Executive Vice President, General Counsel & Chief Strategy Officer
Ms. Vaczy 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. Most recently, Ms. Vaczy has provided strategic advisory services to early-stage biotechnology companies. In 2005, Ms. Vaczy co-founded and served for ten years on the senior leadership team of NeoStem, Inc. (now Caladrius Biosciences). This Nasdaq-listed clinical-stage biotechnology company combined a leading cell and gene therapy process development and manufacturing organization (sold to Hitachi Chemical) with a development pipeline of cell therapy products.
Manager of Manufacturing
Aubrie Vannasse joined Genprex as the Manager of Manufacturing in January 2021, where she is responsible for managing and organizing manufacturing shipping logistics with our manufacturers and our clinical trial sites and the development of the Genprex Quality Management System. Most recently, she was the production manager for Piaggio Fast Forward, where she led manufacturing for the company’s product line. Before joining Genprex, Aubrie has held several roles in the medical device, healthcare, and product development space. She completed a fellowship with Boston Medical Center, serving as the administrative coordinator, where she helped establish Boston Medical Center’s Anesthesia Department, working directly with the Chief of Anesthesiology. Before joining Genprex, Aubrie has held several quality engineering roles, giving her overall product development, quality assurance, and project management experience. Aubrie graduated from Worcester Polytechnic Institute with a BS in biomedical engineering concentrating on tissue engineering.
Board of Directors
James E. Rothman, PhD
Strategic Advisor to the Board of Directors
Dr. Rothman is an internationally renowned scientist. He was awarded the 2013 Nobel Prize in medicine and has received numerous other honors, including the Lasker Basic Research Award. Dr. Rothman is also a biopharmaceutical company founder, life science industry executive, and prestigious academic leader. Dr. Rothman served as chief scientist and executive committee member at GE Healthcare, a $15B unit of General Electric Corporation. Before Amersham Biosciences PLC’s acquisition by GE Healthcare, Dr. Rothman served as chief scientist at Amersham. His distinguished academic career includes endowed chairs at Memorial Sloan-Kettering Cancer Center. He served as vice-chair of the Sloan-Kettering Institute, Columbia University’s College of Physicians and Surgeons, and Yale University, where he is currently professor and chair of cell biology and executive director for high throughput cell biology. He is a member of the National Academy of Sciences, a member of the Institute of Medicine of the National Academy of Sciences, and a fellow of the American Academy of Arts and Sciences.
Brent Longnecker has more than 30 years of corporate governance experience, executive compensation, and risk management consulting for public, private, and non-profit organizations. Mr. Longnecker built one of the country’s leading privately-held executive compensation and corporate governance consultancies, serving domestic and international markets. Mr. Longnecker has deep expertise in healthcare, energy, real estate, manufacturing, and financial companies, regularly consulting with boards of directors, CEOs, key executives, and advisors in many major industries. He is a prolific author on the subjects of executive compensation and corporate governance.
Jose A. Moreno Toscano
Jose A. Moreno Toscano brings over 20 years of experience in the pharmaceutical and biotechnology industries, building, developing, and transforming organizations. Mr. Moreno Toscano has a successful track record of identifying and capitalizing on opportunities to drive exponential revenue growth and market expansion, revitalizing underperforming operations, and establishing foundations for successful start-up operations. His experience includes strategic planning, corporate restructuring, business development, M&A, investor relations, and general management.
William Wilson, Jr.
William R. Wilson, Jr. has more than 40 years of experience as an attorney, with legal experience spanning health care regulation, biotechnology, clinical trial management, nursing home licensing and regulation, physician accreditation, securities, corporate governance, and contractual matters. He previously served as Judge of the 250thDistrict Court of Travis County, Texas, where he presided over civil litigation and Assistant District Attorney for Dallas County, Texas.
Scientific Advisory Board
Jack A. Roth, MD, FACS
Jack A. Roth, MD, FACS, is the Chairman of our SMA Board. Dr. Roth is an internationally renowned cancer expert and oncology pioneer. He is Professor and Distinguished Chair of Thoracic Surgery, Professor of Molecular & Cellular Oncology, Director of the Keck Center for Innovative Cancer Therapies, and Chief of Section of Thoracic Molecular Oncology at The University of Texas MD Anderson Cancer Center. Dr. Roth is a prolific inventor and the author of more than 600 peer-reviewed publications. He is a pioneer in the clinical use of DNA as a therapeutic agent. He is the first clinical investigator approved by the FDA and NIH-RAC to conduct direct patient gene therapy clinical trials. Dr. Roth has over 20 years of experience developing new cancer therapeutics for commercial application and is an inventor of Genprex’s critical intellectual property.
George K. Gittes, MD
SAB Board Member
George K. Gittes, MD, serves as the Chief of Pediatric Surgery and Surgeon-in-Chief Emeritus at the UPMC Children’s Hospital of Pittsburgh. He was also appointed Director of the Richard King Mellon Foundation Institute for Pediatric Research and Co-Scientific director at UPMC Children’s Hospital in 2018. Before UPMC, Dr. Gittes served as the Director of Surgical Research at Children’s Mercy Hospital in Kansas City and held the Thomas M. Holder and Keith W. Ashcraft Chair in Pediatric Surgical Research. During his time in Kansas City, he was also elected as President of the Society of University Surgeons.
Pasi Antero Jänne, MD, PhD
SAB Board Member
Pasi Antero Jänne, MD, Ph.D., is an Associate Professor of Medicine at Harvard Medical School and a clinician at Dana-Farber Cancer Institute Lowe Center for Thoracic Oncology. Dr. Jänne is a leading researcher in medical oncology and lung cancer and is the Lung Cancer Program’s Co-Leader at Dana-Farber Harvard Cancer Center. His research includes the study of epidermal growth factor receptor mutations in non-small cell lung cancer and their impact on the efficacy of EGFR-targeted therapeutic agents, as well as mechanisms of sensitivity and resistance, targeted cancer therapies.
Tony S.K. Mok, MD, FRCP
SAB Board Member
Tony S.K. Mok, BMSc, MD, FRCPC, FHKCP, FHKAM (Medicine), is a professor in the Department of Clinical Oncology at the Chinese University of Hong Kong in Prince of Wales Hospital in Hong Kong. Dr. Mok formerly served as President of the International Association for the Study of Lung Cancer (IASLC), Vice-Secretary General of the Chinese Society of Clinical Oncology (CSCO), and Co-Founder of the Lung Cancer Research Group, a multi-center organization serving the Asian-Pacific region.
George Simon, MD, FACS
SAB Board Member
George Simon, MD, is a Professor of Medicine and Section Chief, Translational Research, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, where his principal focus includes translational research in lung cancer to predict the most effective therapeutic options based upon a tumor’s molecular profile.
Clinical Advisory Board
Andrew B. Becker, MD, PhD
Clinical Advisory Board Member
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 to large multinational pharmaceutical companies on a global basis. Dr. Becker received both his medical degree and Ph.D. in Molecular Pharmacology from Stanford University.
Michael Morse, MD, MHS, FACP
Clinical Advisory Board Member
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 managing gastrointestinal malignancies, including colon, hepatobiliary, gastroesophageal, and pancreatic cancer. His research expertise includes the development of targeted therapies, including immunotherapies for cancer. He has extensively published 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 several 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, the American College of Physicians, and the Society for the Immunotherapy of Cancer.
Col. George E. Peoples, MD, FACS
Clinical Advisory Board Member
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, 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 United States Military Cancer Institute’s past Military Director. 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.
William E. Gannon, Jr., MD, MBA
Clinical Advisory Board Member
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. He also has a strong background in oncology and gene therapy.
Source 1: https://www.genprex.com/news/genprex-completes-manufacturing-scale-up-for-clinical-grade-production-of-reqorsa-immunogene-therapy-for-upcoming-acclaim-1-and-acclaim-2-clinical-trials-for-lung-cancer/
Source 2: https://www.genprex.com/programs/lung-cancer/
Source 3: https://www.genprex.com/downloads/investor-presentation.pdf
Source 4: https://www.genprex.com/downloads/january-2021-shareholder-letter.pdf
Source 5: https://www.genprex.com/news/genprex-completes-manufacturing-scale-up-for-clinical-grade-production-of-reqorsa-immunogene-therapy-for-upcoming-acclaim-1-and-acclaim-2-clinical-trials-for-lung-cancer/
Source 6: https://www.genprex.com/news/genprex-is-on-the-cutting-edge-of-lung-cancer-treatment-development/
Source 7: https://stockcharts.com/h-sc/ui?s=GNPX&p=D&yr=0&mn=3&dy=0&id=p40387643195&a=922390122&listNum=3
Source 8: https://www.barchart.com/stocks/quotes/GNPX/opinion
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Address: 1601 Trinity Street, Building B Suite 3.322 Austin TX 78712-1885 US
Phone: (877) 774-4679
Genprex Inc is a clinical stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.