Lung cancer causes more deaths among men and women than any other form of cancer. According the World Health Organization, lung cancer is the leading cause of cancer deaths worldwide as of 2015, killing more people than breast and liver cancers. Each year there are over 1.8 million new lung cancer cases and 1.6 million deaths from lung cancer worldwide, and in the United States there are over 225,000 new cases and more than 150,000 deaths from lung cancer per year. Non-small cell lung cancer (NSCLC) represents 80% of all lung cancers.
Now, despite great advancements in medical technology and drug development, according to a 2016 American Cancer Society Report, the five-year survival rate for Stage IV (metastatic) NSCLC is about 1%. That said, medical professionals should not give up their efforts and should stay open to new ideas and approaches.
For example, targeted cancer therapy is starting to gain favor over conventional chemotherapies in some clinical oncology practices. Chemotherapy is the standard treatment for the majority of NSCLC patients; but because it is a systemic, rather than a targeted approach to treating cancer, chemotherapy also kills healthy cells and has a number of other side effects. There are differences between cancer cells, which has lead researchers to develop targeted drugs that zone in on these differences.
Unfortunately, many cancer patients who do not meet a specific genomic profile and are unable to access these targeted therapies. That means many lung cancer patients never get to experience the potential benefits of targeted cancer therapy.
However, there’s this tiny company based out of Austin, Texas… that aims to change that. Now, if you haven’t heard of them yet, that’s okay because the company has just held its initial public offering (IPO) and began trading on the NASDAQ exchange on March 29th, 2018.
Genprex, Inc. (NASDAQ: GNPX)
Genprex was founded in 2009 and is headquartered in Austin, Texas. Today, “Genprex technologies are being developed to overcome genomic limitations” existing “in targeted therapies and provide new treatment solutions to large cancer patient populations.”
“Genprex is a clinical stage gene therapy company developing a new approach to treating cancer, based on its novel proprietary technology platform.” This includes its “initial product candidate – Oncoprex™ immunogene therapy.”
The company has a portfolio consisting of “30 issued and 2 pending patents”, covering its technologies.
Its “platform technologies are designed to deliver cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles.” After that, they are delivered “intravenously and taken up by tumor cells where they express proteins that have been found to be missing or in low quantities.”
Promising First Candidate With A Cutting-Edge Gene Therapy Platform
Oncoprex has multimodal mechanism of action whereby it interrupts cell signaling pathways that are known to cause cancer cell replication and proliferation. Oncoprex re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells.
In addition, “Oncoprex has also been shown to block mechanisms that create drug resistance.” The firm is in the process of conducting “the second phase of a Phase I/II clinical trial” at an internationally renowned cancer center in Houston, Texas.
Using its proprietary nanovesicle delivery technology, a Phase I clinical trial showed that Oncoprex therapy selectively and preferentially targeted primary and metastatic tumor cells, resulting in anticancer activity.
Genprex Has A Growing Pipeline and is Tapping into an Unmet Market
Genprex’s clinical stage candidate targets treatment of non-small cell lung cancer. According to a November, 2016 GlobalData report on NSCLC, the non-small cell lung cancer therapeutics market is projected to grow to $26.8B by 2025, or a compound annual growth rate of 15.7%. Some of the largest players in the market are involved in the space; they include: Novartis, AstraZeneca, and Pfizer.
There is a large unmet medical need for lung cancer patients. Each year there are over 1.8 million new lung cancer cases and 1.6 million deaths from lung cancer worldwide, and in the United States there are over 225,000 new cases and more than 150,000 deaths from lung cancer per year. Non-small cell lung cancer (NSCLC) represents 80% of all lung cancers. Studies have shown the 5-year survival rate of Stage IV non-small cell lung cancer (NSCLC) to be approximately 1%, and the median survival rate is approximately 4 months. The outcomes for late-stage lung cancer patients have not improved significantly in over two decades. However, with Oncoprex, Genprex is looking to address this substantial need for treatment.
If Oncoprex receives FDA approval, it could potentially have a substantial share of the non-small cell lung cancer treatment market. Following its recent IPO, market participants may catch wind of its treatment and potentially drive significant interest towards the company.
The company’s therapy is already in clinical trials.
A Phase I clinical trial evaluating Oncoprex as a monotherapy against NSCLC has been completed, and the Company is now in the Phase II portion of a Phase I/II clinical trial in order to evaluate intravenous Oncoprex in combination with erlotinib (Tarceva®) in stage IIIB/IV lung cancer patients without an activating EGFR mutation, as well as patients with an activating EGFR mutation whose cancer has progressed on erlotinib therapy.
Now, if this clinical trial is successful, Genprex would be one step closer to bringing its product to the market. Consequently, the company would be closer to generating revenues. If this trial has a positive outcome, Genprex could see a significant surge in investor interest towards the company.
A Team Of World Class Medical Professionals Is Behind Genprex (NASDAQ: GNPX)
CEO, Rodney Varner brings over 30 years of experience, including corporate law and governance in the biotech industry. Julien Pham, COO of Genprex, brings over 15 years of experience in clinical medicine and research to the team. He was a former faculty member at Harvard Medical School. CFO, Ryan Confer, has years of experience in financial analysis and corporate management. Elizabeth Han, Corporate Counsel, comes from an international law firm with a background in healthcare regulatory matters.
The company’s Board of Directors is equally impressive. The Strategic Advisor to the Board, Dr. James E. Rothman, PhD won the 2013 Nobel Prize in Medicine and Physiology.
Not only that, but the company has a highly accomplished scientific advisory board.
It’s this type of leadership that has investors excited about Genprex’s prospects for the future. Ultimately, such world-class medical professionals may help build a bridge between the company and larger players in the industry.
Genprex is Building Synergies with FDA-Approved Therapies
It’s common to see drug companies form synergies by combining their investigational drug candidates with FDA-approved therapies. Genprex is no different. The company is conducting a Phase I/II clinical study of Oncoprex in combination with Tarceva®, a successful marketed drug, and its research collaborators have conducted, and continue to pursue, pre-clinical research investigating Oncoprex in combination with other investigational and marketed drugs. These combinations may significantly increase the strategic importance of Oncoprex, the company’s main therapy candidate.
The Company’s academic collaborators(researchers a ta major cancer research center located in Houston, Texas) have conducted preclinical studies combining Oncoprex with:
- TKI gefitinib(marketed as Iressa® by AstraZeneca Pharmaceuticals) in animals and in human NSCLC cells
- MK2206in animals (MK2206 is an inhibitor of AKT kinases, which affect cell signaling pathways downstream from tyrosine kinases)
- anti-PD-1 antibody-equivalent to the checkpoint inhibitor nivolumab(marketed as Opdivo® by Bristol-Myers Squibb Company) in animals
- anti-CTLA4 antibody-equivalent to ipilimumab(marketed as Yervoy® by Bristol-Myers Squibb Company) in animals.
If Oncoprex is approved and these studies show strong data, it could further push R&D with the treatment. This should increase the staying power, as well as marketing, of the therapy.
The Bottom Line
There is a large unmet need for non-small cell lung cancer treatment (NSCLC), and Genprex (NASDAQ: GNPX) could fill the void. Outcomes for late-stage lung cancer patients have not changed significantly in many years, but Genprex aims to fix this problem. The non-small cell lung cancer treatment market was valued at $6.2B in 2016 and is projected to grow with CAGR of 7.5%, presenting Genprex with a significant opportunity to expand its business and market value if it continues to successfully execute its vision.
Genprex (NASDAQ: GNPX) could become one of the leaders in NSCLC market with its innovative approach to “personalized” medicine. The company is looking to change the industry and improve outcomes with cutting-edge gene therapy. Genprex is a newly listed publicly traded company as of March 29th, 2018 and could witness increased interest from investors and Wall Street as more investors become familiar with the company.
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