Genprex, Inc. (NASDAQ:GNPX) said the company has been issued a patent that covers using REQORSA Immunogene Therapy in conjunction with immune checkpoint inhibitors for lung cancer.
Thomas Gallagher, senior vice president of Intellectual Property and Licensing at Genprex, said the United States Patent and Trademark Office has granted US Patent No. 11,278,592 B2.
"This new patent provides critical protection for our REQORSA gene therapy in combination with a checkpoint inhibitor, for example an anti-PD1 antibody, to treat cancer. This is important as our ongoing Acclaim-2 phase 1/2 clinical trial combines REQORSA with Keytruda, an anti-PD1 antibody, to treat non-small cell lung cancer," Gallagher said in a statement.
READ: Genprex secures higher dose approval for REQORSA in combination with Tagrisso Phase 1 clinical trial
The patent will safeguard Genprex’s gene therapy, deter would-be competitors, and create value around the company’s core competencies.
Acclaim-2 is an open-label, multi-centre phase 1/2 clinical trial evaluating the company's lead drug candidate, REQORSA Immunogene Therapy, in combination with Keytruda (pembrolizumab) in patients with late-stage, non-small cell lung cancer whose disease progressed after treatment with Keytruda.
In 2021, Genprex received the US Food and Drug Administration's (FDA) Fast Track Designation for the treatment of the Acclaim-2 patient population.
Keytruda is a registered trademark of Merck & Co, and is its largest selling drug with 2021 sales of more than US$17 billion.
Genprex anticipates enrolling patients at approximately 15 clinical sites and estimates phase 1 of the Acclaim-2 trial will enroll up to 30 patients and that phase 2 will enroll approximately 126 patients.
Patients enrolled in phase 2 of the study will be randomly assigned 2:1 to either the REQORSA and Keytruda combination therapy or to chemotherapy (docetaxel with or without ramucirumab).
Patients will be treated until disease progression or unacceptable toxicity is experienced. Patients must have histologically confirmed unresectable stage 3 or 4 non-small cell lung cancer with radiological progression on Keytruda and an ECOG performance status of 0 to 1. Genprex expects to complete phase 1 of Acclaim-2 by mid-2023.
REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer uses Genprex's proprietary ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials.
The active ingredient in REQORSA is the TUSC2 gene, a tumour suppressor gene. REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge.
Once REQORSA is taken up into a cancer cell, the TUSC2 gene is activated, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell.
REQORSA has a multimodal mechanism of action whereby it interrupts cell signalling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.
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.
Contact the author at susie@proactiveinvestors.com