Genprex, Inc. has received notices of allowance from both the U.S. Patent and Trademark Office and the European Patent Office for patents covering the use of its lead gene therapy candidate Reqorsa in combination with immune checkpoint inhibitors. The U.S. patent covers combinations with PD-L1 antibodies such as Tecentriq, while the European patent covers combinations with PD-1 antibodies. Both patents will expire in 2037 at the earliest.
Expanding Global Patent Portfolio
The Austin-based clinical-stage gene therapy company has been building a comprehensive intellectual property estate around its oncology program. Genprex has already secured patents for Reqorsa combinations with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel.
For PD-1 antibody combinations, Genprex has been granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore. These patents would be applicable to the company's ongoing Acclaim-3 clinical trial should the pending applications be granted.
"We are very proud to continue building a fortress of intellectual property protection around our oncology program for REQORSA, and these newly granted patents strengthen and expand our intellectual property estate for REQORSA in combination with immune checkpoint inhibitors applicable to our Acclaim-3 clinical trial," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex.
Clinical Development in Small Cell Lung Cancer
The Acclaim-3 study is a Phase 1/2 clinical trial evaluating the combination of Reqorsa and Genentech's Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). The trial targets patients who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as initial standard treatment.
The Acclaim-3 clinical trial has received significant regulatory recognition, including U.S. Food and Drug Administration Fast Track Designation for this patient population and FDA Orphan Drug Designation, highlighting the unmet medical need in this indication.
Gene Therapy Technology Platform
Genprex's oncology program utilizes its systemic, non-viral Oncoprex Delivery System, which encapsulates gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The product is administered intravenously and is taken up by tumor cells, which then express tumor suppressor proteins that were deficient in the tumor.
The company's lead product candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Each of Genprex's lung cancer clinical programs has received Fast Track Designation from the FDA for the treatment of their respective patient populations.
PD-L1 and PD-1 antibodies represent a type of targeted immunotherapy and are part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-L1 and PD-1 immune checkpoint proteins present on the surface of cells. The combination approach aims to leverage both gene therapy and immunotherapy mechanisms to enhance treatment efficacy in lung cancer patients.
