Genprex (NASDAQ: GNPX)
What is Genprex?
Genprex (GNPX) is a biotechnology company out of Austin, Texas that is focused on developing life-changing gene therapies for patients with cancer and diabetes through unique, innovative science.
Proprietary Technology Delivery Platform (ONCOPREX)
Oncoprex is a nanoparticle delivery platform, which delivers cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.
Non-Viral Vectors vs. Viral Vectors
A big issue with gene therapies is the need for viral vectors in order to go in and edit the genes. Viral vectors are the currently the most effective way to administer gene therapies, but pose many unwanted side effects.
Genprex's non-viral vector delivery platform(Oncoprex) gives them an advantage against viral vector gene therapies.
The nanovesicles are taken up by tumor cells after Oncoprex immunogene treatment at 10 to 25 times the rate at which they are taken up by normal cells.
REQORSA is their lead product candidate (non-proprietary name quaratusugene ozeplasmid).
FDA Fast Track on January 14, 2020 specifically for non small cell lung cancer (NSCLC).
The active ingredient is TUSC2 (Tumor Suppressor Gene 2).
On May 5, 2020 GNPX entered into an exclusive agreement with University of Texas MD Anderson Cancer Center. Read more here.
GPX-002 is a gene therapy for Type 1 & 2 Diabetes and the most recent licensed technology addition.
Developed by a team led by Dr. George Gittes at University of Pittsburgh.
On February 11, 2020 signed an exclusive license agreement with University of Pittsburgh.
Diabetic mice studies have shown restored normal glucose levels for up to 4 months which could translate to decades in humans. (checked the date of these studies... 2018).
Currently finishing up non-human (primate) preclinical trials and to collect final data in preparation for human trials.
Dr. Gittes awarded $2.59 million from NIH NIDDK to assist development for his research project titled, “Alpha Cell Conversion to Beta Cells in Non-human Primates” and will build upon his accumulating groundbreaking gene therapy work toward finding a cure for diabetes.
more info on GPX-002 here.
Connecting the Dots (Manufacturing)
On June 16, 2020 announced manufacturing partnership with Aldevron to advance Oncoprex clinical development.
On June 3, 2020 (13 days prior), Aldevron announced plans to expand manufacturing capacity 10x with new 14-acre campus.
Plans to be fully operational by Q1 2021.
QUOTE: “This plan is designed to serve the biopharmaceutical industry with the world’s most advanced manufacturing platforms for gene and cell therapy,” - Michael Chambers, CEO of Aldevron.
QUOTE: "Upon completion of the campus, the annual capacity will exceed $1 Billion of plasmid DNA, RNA, gene editing enzymes, and other biologics."
Interview with Rodney Varner, CEO of Genprex, confirms GNPX and Aldevron relationship dates back to 2012.
Aldevron scaling up tenfold while Genprex is in the midst of a FDA fast track approval AND both parties locking in that partnership gives me the sense both are fairly confident in the data.
Added to Russell 3000 index
Potential of entering ALL CANCER MARKETS as they have stated the technology is not isolated to one specific cancer type.
GNPX was trading at .37 before it was FDA fast tracked in Jan 2020. That plus the following catalyst sent it all the way to $7. It has since dropped to the $3 area and found a base. I believe there are 15+ catalysts in the next 5 years that could easily send this stock way above $7. A few would be
A $78 billion market for diabetes therapeutics in 2026.
A $26 billion market for lung cancer in 2024.
Have obtained preclinical data showing TUSC2 could be effective against Triple Negative Breast Cancer, Thyroid cancer, Glioblastoma, Kidney cancer, head & neck cancer, and tissue sarcomas.
File IND application to initiate clinical trial of Oncoprex in combination with pembrolizumab (Merck's Keytruda).
Possible FDA Fast Track Designation for Oncoprex & Dr. Gittes GEN-002 diabetes treatment.
Update on data from current FDA Fast Track Designation for Oncoprex in combination with Osimertinib (AstraZeneca's Tagrisso).
3 offerings for approx. $40 million combined in 2020 to help fund clinical trials and have received other additional fundings ($2.6 million NIDDK). They have no outstanding debt as of March 30, 2020.
Market Cap: $273.51 million
OS: 43.28 million
Float: 33.05 million
% held by Insiders: 17.55%
% held by Instituions: 23.36%
October 29, 2020
Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small Cell Lung Cancer
October 30, 2020
Genprex Unveils New Branding for Upcoming Combination Clinical Trials in Non-Small Cell Lung Cancer
November 10, 2020
Genprex Strengthens Scientific Advisory Board with Appointment of Lead Researcher of University of Pittsburgh, George K. Gittes, MD
November 30, 2020
Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer
December 8, 2020
Genprex Completes Manufacturing Technology Transfer for Novel Gene Therapy
December 22, 2020
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
Genprex Achieves Major Manufacturing Milestone for REQORSA™ Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer
I am bullish for GNPX in the next 2-5 years specifically as the majority of these trials will take time. All of this information is provided within the links attached above. I invite comments, concerns, and additional information I missed. Hope everyone enjoys. Best of luck to everyone with their trades/research