GNPX News & Events

Genprex announced that the Japanese Patent Office has issued a favorable Appeal Decision to grant a patent claiming the use of Reqorsa Gene Therapy in combination with PD-L1 antibodies to treat cancer. Also, the European Patent Office has issued a Decision to Grant relating to a patent for the combination of Reqorsa and PD-1 antibodies to treat cancer. Genprex maintains an exclusive license to these patents. The company already holds granted patents for the use of Reqorsa in combination with PD-L1 antibodies in the U.S. and Korea, with a pending grant in Australia. Genprex also holds granted patents for the combination of Reqorsa and PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and Europe.

Genprex announced preliminary in vivo preclinical proof-of-concept data for GPX-002, the company's diabetes gene therapy drug candidate which may have the potential for long-term control of Type 1 diabetes and Type 2 diabetes, in a non-human primate model of T2D and in a mouse model of T2D. Genprex's research collaborators are conducting preclinical studies of GPX-002 in naturally occurring T2D NHP models. The first NHP was treated with a novel infusion process whereby GPX-002 is administered directly into the pancreatic duct using an adeno-associated virus vector containing the Pdx1 and MafA genes and an insulin promoter. The second NHP was treated with GPX-002 by direct injection into the pancreas. "The progression from mouse model studies into NHP studies demonstrates the progression of preclinical drug development of GPX-002 toward human clinical trials," said Mark Berger, MD, Chief Medical Officer at Genprex. "We have demonstrated proof-of-concept in Type 1 diabetic mouse models, where GPX-002 converted alpha cells into beta-like cells that appropriately produced insulin and normalized blood glucose levels, as well as in Type 2 diabetic mouse models, where beta cells are rejuvenated. Moving into NHP studies in both Type 1 and Type 2 diabetes has enabled us to establish critical proof-of-concept advancements in models that share significant metabolic similarities with humans."

Genprex announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy in combination with Tagrisso in patients with advanced non-small cell lung cancer, NSCLC, in the peer-reviewed journal Clinical Lung Cancer. The reported results showed no Dose Limiting Toxicities, DLTs, established a Recommended Phase 2 Dose, RP2D, of 0.12 mg/kg and provided data showing early efficacy of REQORSA in combination with osimertinib. Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.