On July 5, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the China National Intellectual Property Administration has granted Genprex China Patent No: 201780076886.X (Press release, Genprex, JUL 5, 2023, View Source [SID1234633051]). The broad patent covers the use of Genprex’s lead drug candidate, REQORSA Immunogene Therapy, in combination with PD1 antibodies through 2037.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is a very important patent because it provides Genprex with additional protection for our REQORSA gene therapy in combination with PD1 antibodies, such as Keyruda, which is the subject of our ongoing Acclaim-2 clinical trial for the treatment of lung cancer," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "Genprex has already received this patent protection in the U.S., Japan, Australia, Russia and Mexico. Now with the same patent protection in China, we have secured exclusivity for this drug combination for the treatment of cancer in many of the largest markets. This patent protection prevents others from making, using or selling this drug combination."

Acclaim-2 is an open-label, dose escalation and clinical response study of REQORSA in combination with Keytruda in patients with advanced, metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. More information on Acclaim-2 can be found at www.clinicaltrials.gov Identifier NCT05062980.

In 2022, Genprex received a U.S. patent granting protection for the combination of REQORSA with PD1 antibodies for the treatment of cancer. In 2021, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-2 patient population.

About Acclaim-2

The Acclaim-2 trial is a Phase 1/2 open-label, dose-escalation and clinical response study of REQORSA in combination with Keytruda in patients with advanced, metastatic non-small-cell lung cancer who have progressed after treatment with Keytruda. The Company anticipates enrolling patients at approximately 10 clinical sites and estimates that the Phase 1 dose escalation portion of the Acclaim-2 trial will enroll up to 18 patients, the Phase 2 expansion portion will enroll approximately 36 patients, and the Phase 2 randomized portion will enroll approximately 126 patients. Patients enrolled in the Phase 2 randomized portion of the study will be randomized 2:1 to either 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 III or IV NSCLC (any histology) with radiological progression on Keytruda and an ECOG performance status of 0 to 1. Genprex expects to complete enrollment for the Phase 1 dose escalation portion of Acclaim-2 by the first quarter of 2024.