- Developing potentially life-changing technologies for cancer patients, based upon unique proprietary technology platform
- Initial product candidate, immunogene therapy Oncoprex designed for non-small cell lung cancer.
- Study of Oncoprex, completed at the University of Texas in April, showed positive results
- Partner Aldevron has successfully completed manufacturing of Tumor Suppressor Candidate 2 (TUSC2) gene DNA
What Genprex does:
Genprex, Inc. (NASDAQ:GNPX) is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy for non-small cell lung cancer.
The Austin, Texas-based firm’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.
Oncoprex works partly by interrupting the cell signaling pathways that prompt cancer cells to multiply as well as controlling the immune response against cancer cells.
It is basically the tumor suppressor candidate 2 (TUSC2) gene wrapped in a cholesterol nanoparticle that is engineered to target cancer cells.
The nanoparticles are attracted by the opposite electrical charge of tumors, and they pass more easily through immature blood vessels that grow quickly around tumors.
That’s a big advantage because the nanotechnology can be injected intravenously, so it goes through the whole body, as opposed to many traditional gene therapies using viral delivery systems that have been injected directly into tumors.
Thus, Oncoprex can attack metastatic tumors in hard to reach places or are too small to detect.
The Nanoparticles are absorbed by tumor cells at rate 10 times to 25 times higher than normal cells, but have little or no effect on normal cells, so toxicity to patients is low relative to other lung cancer drugs.
Genprex went public in April 2018, listing on the Nasdaq under the ticker “GNPX” and raising US$6.4 million. A private investment in public equity, or PIPE, in May that year raised an additional US$10 million.
The firm currently has a market cap of around $13.6 million based on its current price of $0.8223 per share.
How’s it doing:
At the start of July, Genprex said a study of Oncoprex, completed at the University of Texas in April, showed positive results.
The study had examined the effects of the tumor suppressor gene TUSC2 found in Oncoprex in combination with immunotherapy treatment.
The study was part of a sponsored research agreement between the company and the UT MD Anderson Cancer Center, and research is still ongoing.
At the American Association of Cancer Research meeting in April, MD Anderson shared a poster titled, “Development of an improved humanized patient-derived xenograft, Hu-PDX, mouse model for evaluation of antitumor immune response in lung cancer.”
The poster demonstrated that TUSC2 combined with a checkpoint blockade was more effective than a checkpoint blockade alone in increasing the survival of mice with human immune cells that had metastatic lung cancer.
The data showed that TUSC2 treatment with the checkpoint inhibitor pembrolizumab “slowed tumor growth significantly.”
Researchers are also looking into TUSC2 used in concert with small molecule drugs and immunostimulatory adjuvants, which activate the body’s immune system.
“Recent studies have shown that less than half of cancer patients qualify for approved immunotherapies based on the patient’s PD-1 or PD-L1 protein expression level,” said Genprex’s Chief Operating Officer Julien Pham.
“Current immunotherapy treatment is only benefitting a small number of cancer patients. We are working to fill this gap by combining our lead drug candidate with approved immunotherapies to give patients more treatment options,” he added.
On August 6, Genprex revealed that its partner, Aldevron has successfully completed manufacturing of the TUSC2 plasmid DNA for Oncoprex.
The gene therapy treatment consists of a TUSC2 plasmid DNA gene encapsulated in a nanovesicle made from lipid molecules with a positive electrical charge.
Historically, the manufacturing steps of combining the plasmid DNA with the lipid nanovesicles of Oncoprex has been done for Genprex at the MD Anderson Cancer Center, which has been undertaking research studies on the gene therapy.
Since Genprex’s IPO, the company has been working to transfer and scale up these processes through other contract manufacturers.
The company pointed out that that the US Food and Drug Administration (FDA) has made manufacturing a top priority for cell and gene therapy companies.
Senior team strengthened
Earlier this year, the company strengthened its senior team with the appointment of Eric Chapdelaine as senior director of Pharmaceutical Sciences and Manufacturing to support the company’s manufacturing, technical operations, and supply chain management.
He joined Genprex from Cognate BioServices where he served as the director of quality control and analytical development and oversaw a staff of more than 40 working on cell and gene therapy in laboratories.
Aside from Chapdelaine, Genprex also added to its management team in February with the appointment of Kalyn Dabbs as a senior manager of communications and marketing.
Dabbs took responsibility for communications as well as marketing plans and the company’s digital strategy. Before signing on at Genprex, Dabbs spent six years working in various communications and marketing roles in the healthcare and wellness industries.
And earlier in the same month Genprex appointed pharma veteran Dr John N. Bonfiglio to its board of directors.
Bonfiglio brought more than 30 years of experience in the pharmaceutical and biotech industries, starting as a scientist at Allergan PLC (NYSE:AGN) and holding executive roles at Peregrine Pharmaceuticals Inc, Cypress Bioscience Inc, The Immune Response Corporation and Argos Therapeutics Inc, among others.
First phase of branding
On July 31, Genprex revealed that it has initiated the first phase of branding for its lead drug candidate and has completed the creation and submission of non-proprietary drug name selections to the American Medical Association’s United States Adopted Names (USAN) Council.
The group said, upon receiving feedback from the USAN Council - which is expected later this year – it will submit its non-proprietary drug name selections to the World Health Organization for International Nonproprietary Names (INN) status.
The company expects to obtain an approved non-proprietary drug name by mid-year 2020.
The development of non-proprietary and proprietary drug names is based on regulatory requirements by several governing bodies, including the American Medical Association’s USAN Council, the World Health Organization’s INN Programme, the European Medicines Agency (EMA) and the FDA.
Non-proprietary drug names are typically designated based on the active ingredient or molecular composition of the drug.
Specific to gene therapy, the nomenclature for products produced by insertion of genetic material into a vector where altered genetic material is administered to patients as a biologic drug is based on the drug candidate’s gene composition and the vector used to deliver the gene, thus requiring a two-word nomenclature scheme.
- Further research studies for Oncoprex to come from the UT MD Anderson Cancer Center,
- More news on scaling up of the manufacturing processes from Aldevron
- Non-proprietary drug name approval by mid-year 2020.
What the boss says
Rodney Varner, chairman and chief executive officer of Genprex commented in July: “Developing and obtaining regulatory approval of a non-proprietary drug name is a requirement for bringing our lead drug candidate to market.”
“We’re one step closer to achieving this regulatory milestone. An approved non-proprietary drug name will also make our lead drug candidate more widely recognizable to clinicians and physicians and most importantly, to patients living with non-small cell lung cancer.”