REQORSA® Immunogene Therapy
The First Systemically Delivered Gene Therapy Used for Cancer in Humans
The company's lead product candidate, REQORSA®, immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which they believe is the first systemic gene therapy delivery platform used for cancer in humans.
In 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® (osimertinib) in late-stage NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso.
In 2021, the FDA granted Fast Track Designation for REQORSA in combination with Merck & Co’s Keytruda® (pembrolizumab) in late-stage NSCLC patients whose disease progressed after treatment with Keytruda.
The company believes that REQORSA, unlike other gene therapies, which either need to be delivered directly into tumors or require cells to be removed from the body, re-engineered and then reinserted into the body, is the first systemic gene therapy used for cancer in humans.
Diabetes Gene Therapy
GPX-002, a gene therapy for diabetes, is the most recent addition of the company's licensed technologies. GPX-002 was developed by researchers at the University of Pittsburgh. Diabetic mice studies have shown that GPX-002 restored normal blood glucose levels for an extended period of time, which could translate to decades in humans.
This gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.
The diabetes gene therapy, GPX-002, is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. 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.
Diabetic mice studies show that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.
The diabetes gene therapy was developed by Dr. George Gittes, a researcher at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, where preclinical research is ongoing. GPX-002 has been tested in vivo in mice and nonhuman primates. Once sufficient preclinical data has been generated, they expect to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.
ONCOPREX® Nanoparticle Delivery System
The oncology drug development program utilizes our unique, proprietary non-viral ONCOPREX Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. This platform, originally developed through collaborative research between the University of Texas MD Anderson Cancer Center and the National Institutes of Health, has been optimized to work with our initial product candidate, REQORSA® immunogene therapy.
Designed to Deliver Cancer-Fighting Genes Systemically
The ONCOPREX platform has been designed and optimized to deliver cancer-fighting genes into the patient’s body systemically. Using this system, the company encapsulates plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells. Their nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and have been clinically shown to deliver molecular kinase inhibitors effectively.
Company Website. Company Presentation.
And right now, based on multiple potential catalysts, past champ GNPX needs to be on your radar. Check them out:
No. 1 GNPX Potential Catalyst - Noble Capital Markets Slaps GNPX With $5.00 Target (Over 200% Potential Upside)
Back in August of 2022, Noble tagged a $5.00 target on GNPX.
From Tuesday's closing valuation, that provides GNPX with a staggering 200+% of potential upside.
And just to throw this tidbit in, GNPX also has a 52-week high of $3.62 providing 100+% potential upside.
In other words, GNPX could be trading at extremely undervalued levels.
Could that be why it's been running so hot in recent sessions? Has Wall Street finally picked up on GNPX's scent?
Now, I'm not saying that GNPX is going to go surging to either of those levels this week, but the potential upside needs to be noted.
No. 2 GNPX Potential Catalyst - A Potential Squeeze Near Term?
Check out GNPX's 6-month chart: