Genprex (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes. The company has announced that the Safety Review Committee (“SRC”) approved continuation to the third and final cohort in the dose escalation Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial of REQORSA(R) in combination with Tagrisso(R) (osimertinib) to treat late-stage non-small cell lung cancer (“NSCLC”). In 2020, the REQORSA/osimertinib combination received U.S. Food and Drug Administration’s (“FDA”) Fast Track Designation for treatment of the Acclaim-1 patient population. “The SRC’s recommendation to increase the dosing of REQORSA is further confirmation of its favorable safety profile and it enables us to advance Acclaim-1 into the final cohort of the Phase 1 dose escalation portion of the study,” said Genprex Chief Medical Officer Mark Berger, M.D. “We look forward to completing enrollment of this final cohort in the first quarter of 2023.”
In addition, the company today announced its entry into a license agreement with the University of Pittsburgh. The agreement grants Genprex a worldwide, exclusive license to certain patent applications and related technology and a worldwide, non-exclusive license to use certain related know-how, all related to modulating autoimmunity in type 1 diabetes by using gene therapy. “Gaining exclusive access to technology that modulates the immune system by transforming macrophages could prove to be significant to our broader research partnership with the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine,” Genprex CMO Dr. Berger said in the news release. “We are making significant strides in our program with Dr. Gittes’s innovative approach to treating diabetes by the transformation of alpha cells into beta-like cells and are excited to add to our arsenal this additional technology also out of Dr. Gittes’s lab, in collaboration with the laboratory of Dr. Xangwei Xiao, Assistant Professor of Surgery, also in the Division of Pediatric Surgery at the University of Pittsburgh’s School of Medicine. Not only could this new approach be used to reduce autoimmune activity in type 1 diabetes by modulating the immune system, but potentially it could also work in conjunction with the technology we have licensed previously.”
About Genprex Inc.
Genprex is a clinical-stage gene therapy company focused on developing life-changing treatments 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 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 administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The company’s lead product candidate, REQORSA(TM) (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (“NSCLC”) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (“AAV”) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished. For more information, 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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