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news.The US Patent and Trademark Office (USPTO) has granted a patent to Genprex for the use of its Reqorsa gene therapy in conjunction with programmed death-ligand 1 (PD-L1) antibodies such as Tecentriq (atezolizumab) for cancer treatment.
Genprex has obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea. Credit: National Cancer Institute on unsplash
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The protection for this patent will last until 2037.
Genprex has also obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea, and is advancing additional applications in Canada, China, Brazil, Europe and Israel.
If approved, they will also apply to the Phase I/II Acclaim-3 clinical trial.
Acclaim-3 is assessing the company’s lead drug candidate Reqorsa combined with Genentech’s Tecentriq as maintenance treatment for those with extensive stage small cell lung cancer (ES-SCLC).
The trial is intended for subjects who have received the initial standard of care treatment with Tecentriq and chemotherapy.
Participants will receive Reqorsa and Tecentriq until they experience either progression of the disease or unacceptable toxicity.
The Phase II expansion trial comes after the conclusion of the Phase I dose escalation part of the trial, which indicated that the gene therapy was well-tolerated.
In the Acclaim-3 study, Phase II subjects are given the same dose of the gene therapy as administered in the Acclaim-1’s Phase II portion.
50 subjects are anticipated to be enrolled in the Phase II expansion segment. The primary goal is to assess the 18-week progression-free survival rate from the start date of maintenance treatment involving Reqorsa and Tecentriq in ES-SCLC patients.
Survival outcomes will also be monitored throughout the duration of the study.
An interim analysis is planned after the enrolment and treatment of the 25th subject reaches 18 weeks of follow-up.
Genprex intellectual property and licensing senior vice-president Thomas Gallagher stated: “We continue to build protection around our lead drug candidate, Reqorsa, and this new patent provides the necessary technology protection applicable to our Acclaim-3 clinical trial in small cell lung cancer.”
Genprex anticipates completing enrolment for interim analysis in the study’s Phase II expansion portion in the initial half of 2026. The Acclaim-3 study benefits from US Food and Drug Administration orphan drug and fast track designations.
