Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced that it has received fast track designation (“FTD”) from the U.S. Food and Drug Administration (“FDA”) for its lead drug candidate: REQORSA(TM) Immunogene Therapy. The designation is for REQORSA in combination with Merck & Co’s Keytruda(R) in patients with histologically confirmed unresectable stage III or IV non-small cell lung cancer (“NSCLC”) whose disease progressed after treatment with Keytruda. According to the announcement, GNPX plans to start its Acclaim-2 clinical trial Q1 2022. The trial open-label, multicenter Phase 1/2 clinical trial is designed to evaluate REQORSA in combination with Keytruda for this patient population. This is the second FTD the company has received for REQORSA. “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,” said Genprex president and CEO Rodney Varner in the press release. “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 the third quarter of 2021 and expert clinical trial management led by chief medical officer and industry veteran Mark Berger, MD, 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.”
To view the full press release, visit https://ibn.fm/Uxz6k
About Genprex Inc.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s 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 works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX(R) Nanoparticle Delivery System, which the company believes is the first systemic, gene-therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The company’s lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer. REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In 2020, the U.S. Food and Drug Administration granted fast track designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso(R) (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. For more information, please visit the company’s website at www.Genprex.com.
NOTE TO INVESTORS: The latest news and updates relating to GNPX are available in the company’s newsroom at http://ibn.fm/GNPX
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