Before U.S. markets opened for trading this morning, clinical-stage gene therapy company Genprex Inc. (GNPX:NASDAQ), which in engaged in developing treatments for cancer and diabetes, announced that "the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the company's lead drug candidate, REQORSA™ Immunogene Therapy, in combination with Merck & Co. Inc.'s (MRK:NYSE) Keytruda® in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda."
Genprex advised that it plans to commence its Phase 1/2 Acclaim-2 clinical trial of REQORSA in combination with Keytruda in Q1/22. The multi-center study as designed will focus on patients who have been diagnosed with unresectable stage III or IV NSCLC who have demonstrated disease progression following prior treatment with Keytruda.
The firm pointed out that this marks the second FDA issued FTD for REQORSA. Genprex listed that "it previously received its first FTD for REQORSA in combination with AstraZeneca Plc.'s (AZN:NYSE; AZN:LON) Tagrisso® in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso."
The company's President and CEO Rodney Varner commented, "We are thrilled to receive a second Fast Track Designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor Keytruda…This Fast Track Designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC."
"With a strong balance sheet of $42 million in cash as of the end of Q3/21 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, M.D. who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022, CEO Varner added."
Dr. Berger explained that receipt of Fast Track Designation from the FDA offers companies greater interaction FDA regarding a drug candidate's development program and path toward priority review. "Advanced NSCLC represents a large patient population that is in desperate need of new therapies, Dr. Berger remarked."
The company indicated that data from preclinical animal studies in mice with humanized immune systems showed that when REQORSA was used in combination with Keytruda, it demonstrated greater effectiveness than Keytruda by itself in those mice having metastatic lung cancers. Genprex mentioned that in the prior studies, "mice with a humanized immune system also documented multiple effects of REQORSA on the immune system, such as an increase in Natural Killer cells and a decrease in PD-L1 expression on tumor cells, that is believed likely to contribute to the synergy seen with Keytruda."
In general, companies that have been granted Fast Track Designation for new medicines by the FDA may also benefit from accelerated drug approval and quicker timeframes for processing Biologics License Applications (BLAs) and may also receive priority review status if definitive clinical data is achieved.
The company stated that REQORSA is primarily being developed to address NSCLC. The firm advised that the World Health Organization lists lung cancer as the leading cause of global cancer deaths. Worldwide lung cancer results in more than 1.8 million deaths which is higher than the combined annual totals from breast, colorectal, liver and stomach cancers. The firm stated that NSCLC accounts for approximately 84% of all lung cancer cases.
Genprex is a clinical-stage gene therapy firm based in Austin, Tex. that develops technologies for cancer and diabetes patients. The company listed that "its technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options."
Genprex started off the day with a market cap of around $62.6 million with approximately 47.8 million shares outstanding and a short interest of about 4.5%. GNPX shares opened 15% higher today at $1.51 (+$0.20, +15.27%) over last Friday's $1.31 closing price. The stock has traded today between $1.51 and $3.49 per share and is currently trading at $3.47 (+$2.16, +164.89%).
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