Genprex gene therapy candidate Oncoprex fast-tracking for non-small cell lung cancer treatment

Developing potentially life-changing technologies for cancer patients, based upon unique proprietary technology platform Initial product candidate, immunogene therapy Oncoprex fast-tracked by FDA for non-small cell lung cancer combination use Also has a licensing agreement with the University of Pittsburgh for a diabetes gene therapy 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. How is it doing: Genprex had a great start to 2020, announcing on January 21 that the US Food and Drug Administration had granted Fast Track Designation for its Oncoprex immunogene therapy to treat lung cancer. The FDA gave its approval to the therapy combination with EGFR inhibitor osimertinib - AstraZeneca PLC’s (NYSE:AZN) Tagrisso. That drug had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first nine months of 2019 and is currently AstraZeneca’s highest grossing product for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone. FDA may award Fast Track Designation if it determines that a drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite the review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Genprex said a few weeks later on February 5 that it planned to initiate a Phase I/II clinical trial of Oncoprex combined with osimertinib in mid-2020 at multiple cancer centers across the US. It added that it did not at that time intend to reopen enrollment in its current Phase I/II trial using a combination of Oncoprex and EGFR inhibitor erlotinib (marketed by Genentech in the US and elsewhere by Roche as Tarceva) against NSCLC. However, the group noted that tumor shrinkage in patients resistant to erlotinib enrolled in that trial showed that Oncoprex can overcome resistance to TKIs and provided support for the Fast Track Designation for the combination with osimertinib. Genprex also said it planned to file an amendment to its Investigational New Drug (IND) application with the FDA for the Oncoprex and osimertinib combination therapy trial within the first quarter of 2020. The group said it would also proceed with a plan to file an Investigational New Drug (IND) application for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab -- marketed as Keytruda by Merck & Co Inc (NYSE:MRK) in the US for NSCLC. The FDA fast track designation for NSCLC came after a good run of data for Oncoprex use against other cancers. In September last year, a study by an independent researcher reported that the active ingredient in Oncoprex had been shown to prevent tumor growth in triple-negative breast cancer (TNBC). The study, published in the medical journal 'Nature', showed that researchers found TUSC2, the lead component of the drug, acts as a tumor-preventing gene. Then in November, Genprex revealed positive preclinical data for the treatment of some of the most resistant metastatic lung cancers using its immunogene therapy.  Its collaborators from The University of Texas MD Anderson Cancer Center presented the data at the American Association of Cancer Research Tumor Immunology and Immunotherapy 2019 Meeting.   And at the end of January, Genprex noted that independent researchers had reported in a study that TUSC2, a tumor suppressor gene and the active agent in Oncoprex, is a potential target and biomarker for thyroid carcinoma. Published in the ‘International Journal of Molecular Sciences,’ the study found that TUSC2 overexpression decreased thyroid cancer proliferation, migration and invasion. Cell proliferation, migration and invasion ability are essential steps in tumor metastasis Away from cancer, in February, Genprex also revealed that it has signed a licensing agreement with the University of Pittsburgh for a diabetes gene therapy that could have the potential to cure Type 1 and Type 2 diabetes. The gene therapy, developed at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, allowing them to replenish insulin levels. Cash and board boosts Genprex has also added to its cash coffers. At the end of February, the company closed a $17.5 million offering of 5 million shares, at a price of $3.50 per share, and said it planned to use the proceeds to advance its drug development programs, for working capital and for general corporate purposes. That followed an at-the-market stock offering at the end of January that raised $8 million through the sale of 7.6 million shares at a price of $1.05 per share. On the management front, near the end of March, Genprex appointed two experienced life sciences executives, with Catherine M Vaczy becoming executive vice president and chief strategy officer, while Michael T Redman was appointed executive vice president and chief operating officer. Vaczy has over 20 years' experience as a founder and senior executive of life science companies. Her CV includes experiences with NeoStem Inc (now Caladrius Biosciences), a Nasdaq-listed clinical-stage biotechnology company and ImClone Systems Incorporated (sold to Eli Lily and Company). Meanwhile, Redman brings more than 30 years of experience in the life sciences industry, having been president, CEO and director of Oncolix Inc, a publicly-traded clinical-stage biopharma focused on developing therapies for women’s and children’s cancers. In 2001, he co-founded Opexa Pharmaceuticals, a company developing immunotherapies for a variety of diseases, and served as its president and CEO until 2005. He has worked at Zonagen (now Repros Therapeutics, which is a part of Allergan), Aronex Pharmaceuticals, Biovail Corporation and American Home Products (acquired by Pfizer). A few days later, the group bolstered its board further with the appointment of three new directors. The trio were Brent Longnecker, CEO of Longnecker & Associates; Jose A. Moreno Toscano, CEO at LFB USA Inc; and William R. Wilson, Jr, chairman, president and CEO of Wilson Land & Cattle Co. Inflection points: Start of Phase I/II clinical trial of Oncoprex combined with osimertinib at multiple cancer centers across the US Investigational New Drug application for the additional combination therapy of Oncoprex combined pembrolizumab More news on licensing agreement with the University of Pittsburgh for a diabetes gene therapy What the boss says: In a statement with the FDA Fast Track news in January, CEO Rodney Varner said: “Genprex is excited to receive this important FDA designation.” “In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment,” he added.