Robert LeBoyer is a Senior Equity Research Analyst with over 16 years of industry experience focusing on the Biotechnology and Specialty Pharmaceuticals industry. Robert joined Noble Capital Markets in 2021 to cover the Biotechnology and Specialty Pharmaceuticals industry.
Mr. LeBoyer began his research career at Prudential Securities, and has previously been a Senior Biotechnology Analyst at Brown Brothers Harriman and Leerink Swann, joining Noble from Ladenburg Thalmann. Robert holds a BA in Economics from Tulane University and an MBA from Columbia Business School.
Mr. LeBoyer reiterated a $5.00 target on Genprex, Inc. (Nasdaq: GNPX) after the company announced its Phase 1/2 Acclaim-1 trial in non-small cell lung cancer (NSCLC) had received approval to treat a second cohort at a higher dose.
The approval was based on a review of data from the first cohort by the Safety Review Committee (SRC).
The Phase 1/2 Acclaim-1 trial is testing the combination of REQORSA™ with Tagrisso (osimertinib) in non-small cell lung cancer. This combines Tagrisso’s action as an EGF inhibitor with REQORSA™’s delivery of the TUSC2 cancer suppressor gene.
The TUSC2 gene leads to inhibition of several pathways leading to tumor growth and proliferation, and restores pathways that defend against cancer. The REQORSA™ combination has received Fast-Track designation for NSCLC from the FDA.
The open-label study enrolled patients with late-stage NSCLC that had progressed after treatment with Tagrisso. Patients in the first cohort were treated with a 21-day cycle combining Day-1 intravenous dose of 0.06 mg/kg REQORSA™ with 80 mg of Tagrisso taken daily.
The planned REQORSA™ dose for the second cohort increases to 0.09 mg/kg, followed by 0.12 mg/kg in the third cohort. Phase 1 will enroll up to 18 patients to identify the maximum tolerated dose and select the best dose for Phase 2.
Phase 2 is designed as a double-blind study testing the REQORSA™-Tagrisso combination against Tagrisso alone. The a primary endpoint is progression-free survival (PFS).
Planned enrollment is 74 patients, with an interim analysis planned after 25 patient progressions or deaths.
The ACCLAIM-2 Study Test REQORSA™ With Keytruda. REQORSA™ has also been shown to have effects on the immune response to cancer, including downregulation of the PDL-1 (Programmed death ligand-1) receptor. The interaction of the PD-1/PDL-1 is the target of the checkpoint inhibitor category that is widely used in immunotherapy.
Preliminary data has shown that REQORSA™ improved the response and efficacy in combination with checkpoint inhibitors.
In March 2022, Genprex began enrollment of the Phase 1/2 ACCLAIM-2 study testing REQORSA™ in combination with Keytruda.
This combination has received Fast-Track designation from the FDA.
We are watching for an impulsive break out of this wedge for our squeeze potential
Watch for a volume over 25k the first hour of market open for possible move, and over 200k on daily close.
Volume will precede the move, key indication of our push coming and an impulsive break to the upside.
The global gene therapy market was valued at $2.9 billion (US) in 2021 and is expected to reach over $15.68 billion (US) by 2030, poised to grow at a registered CAGR of 20.2% from 2022 to 2030.
Gene therapy is described as the treatment of an illness by changing, replacing, or supplementing a missing or defective genetic combination that is responsible for the disease.
Gene therapy has become one of the most desirable research goals in the fight against degenerative illnesses. The need for gene therapy is being driven by an increase in the number of cases of cancer and other chronic diseases all across the world.
The advancements in gene therapies are projected to be approved in the upcoming years, contributing to the gene therapy market’s growth from now and into the future.
The gene therapies are designed to treat diseases by altering genetic information, such as inactivating malfunctioning genes or replacing a disease-causing gene with a healthy copy of the gene.
The gene therapy is being utilized to treat a variety of disorders and has demonstrated to be effective. This form of treatment can/could have the potenital to cure diseases such as diabetes, cancer, heart disease, and AIDS.
The growth of the gene therapy market is influenced by factors such as a strong product portfolio, the expanding investments by key market players, and a high prevalence of target diseases and interest in innovative and new therapy.
Furthermore, the increased investment in research and development by government and private organizations will create further prospects for the growth of the gene therapy market during the forecast period as noted in the graph above.
The advanced therapeutic solutions for chronic diseases are being used in developed countries. As a result, traditional treatment methods like chemotherapy, which have adverse side effects and long-term repercussions, are being replaced with this treatment. For the development of such medicines, there is also a shift in trend towards the use of viral vectors, which have a low toxicity and high immunology.
The rapid technological advancements in cellular and molecular biology in genomics research, have contributed greatly to the growing gene therapy market in recent years. The academicians, researchers, and in-house researchers of major market companies with significant funding have all played critical roles.
In many industrialized countries, the frequency of cardiovascular diseases is increasing, and there is a growing need to cure these diseases in less time, resulting in players investing extensively in research and development of highly effective and innovative therapeutics such as gene therapy. The prevalence of rare diseases such as cardiovascular and cancer diseases will have a positive impact on the demand for gene therapy applications.
Currently, only a few market players are dominating the gene therapy market.
These market players are significantly contributing to the market’s expansion.
The core members who are working on item dispatching and other important coordinated activities to strengthen their market reach globally.
To increase their cancer gene therapy research and product portfolio, local and small market players are increasingly partnering and developing alliances with large market players.
Despite the small number of approved drugs, cell and gene therapy companies attract a growing amount and proportion of private and public investment.
Although all private investment in life sciences has grown substantially over the past 10 years, the rapid growth of investment in cell and gene therapy companies is remarkable.
One way to contextualize the substantial growth in investment in cell and gene technologies is to look at forecasted revenue growth for the therapies that are in development.
Based on worldwide sales forecasts from Evaluate Pharma, including both approved drugs and ones forecast to be approved, it is expected that conventional drug sales will grow at a compound annual growth rate (CAGR) of 6% from 2021 to 2026 and biologic sales excluding cell and gene therapies are forecast to grow from $415 billion to $541 billion, a CAGR of 5%.
Cell and gene therapies, in comparison, are expected to grow from $4 billion a year in sales to over $45 billion over that same period, a significantly higher CAGR of 63%.
While the total dollar amount invested in cell and gene is only a fraction of what is put into conventional drugs and biologics, it is important to recognize the spillover effects of this growing capital. Investor interest drives innovation, encourages startups, and attracts experienced talent from competing sectors.
This in turn drives results in the lab and portfolios.
Many saw this happen in the early days of biotechnology, and today traditional pharmaceutical companies continue to lose ground to their biotech peers in terms of investment, talent, and pipeline.
Some anticipate a similar story will play out as cell and gene emerges as its own defined sector in the life sciences ecosystem.
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.
Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans.
ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body.
The Company’s lead product candidate, REQORSA™ is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer.
Genprex’s diabetes gene therapy approach consists of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.
In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.
In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.
Genprex, Inc. (Nasdaq: GNPX) recently announced it has entered into an exclusive license agreement with the University of Pittsburgh, granting the company a worldwide, exclusive license to certain patent applications and related technology and a worldwide, non-exclusive license to use certain related know-how, all related to modulating autoimmunity in Type 1 diabetes by using gene therapy. The preclinical technology transforms macrophages enabling them to reduce autoimmune activity in Type 1 diabetes and could be complementary to the Company’s existing diabetes technology.
“Gaining exclusive access to technology that modulates the immune system by transforming macrophages could prove to be significant to our broader research partnership with the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine,”
Mark Berger, MD, Chief Medical Officer of Genprex.
“We are making significant strides in our program with Dr. Gittes’s innovative approach to treating diabetes by the transformation of alpha cells into beta-like cells and are excited to add to our arsenal this additional technology also out of Dr. Gittes’s lab, in collaboration with the laboratory of Dr. Xangwei Xiao, Assistant Professor of Surgery, also in the Division of Pediatric Surgery at the University of Pittsburgh’s School of Medicine. Not only could this new approach be used to reduce autoimmune activity in Type 1 diabetes by modulating the immune system but potentially it could also work in conjunction with the technology we have licensed previously.”
“With diabetes reaching epidemic proportions around the world, the work Dr. Gittes is pursuing in diabetes is absolutely critical. In the U.S. alone, there are more than 37 million people with diabetes (approximately 1.9 million of whom have Type 1 diabetes) and another approximately 96 million Americans who are pre-diabetic, or have abnormally elevated blood sugar levels. The opportunity to change the course of this disease with gene therapy is extremely compelling, and increasing our exclusive access to intellectual property could prove to be pivotal to our pathway forward,”
Rodney Varner, President and Chief Executive Officer of Genprex.
The Company signed an exclusive license agreement with the University of Pittsburgh in 2020. The gene therapy approach under the original license is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.
In models of Type 1 diabetes, these genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.
In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells will be rejuvenated and replenished.
This gene therapy approach was developed by Dr. Gittes. His preclinical research in this area has been published in peer-reviewed scientific publications, and he is the recipient of several research grants, including a $2.59 million grant awarded by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases.
Earlier studies in diabetic mouse models showed that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months.
It is believed that the duration of restored blood glucose levels in mice could translate to decades in humans. Preliminary data from a more recent study in a non-human primate model of Type 1 diabetes also have been promising. Data from this study are expected to be presented at a scientific meeting during the first quarter of 2023.
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