• Expands on the previously granted patents covering the use of REQORSA in combination with immune checkpoint inhibitors

AUSTIN, Texas, Aug. 13, 2024 /PRNewswire/ -- 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, today announced that the Singapore Patent Office has granted a patent to Genprex that covers the use of the Company's lead drug candidate, Reqorsa^® Gene Therapy, in combination with anti-PD-1 antibodies through 2037.

This patent expands on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile, China and Korea to cover the use of REQORSA in combination with an immune checkpoint inhibitor, i.e., PD-1 antibodies. The granted Korean patent also claims the use of REQORSA in combination with PD-L1 antibodies. Genprex will be pursuing additional patent applications with claims to combinations of REQORSA and PD-L1 antibodies in the US, Brazil, Canada, China, Europe and Israel. Should these applications grant, they would be applicable to Genprex's Acclaim-3 clinical trial.

PD-1 inhibitors and PD-L1 inhibitors are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.

"This patent expands our intellectual property portfolio, providing us with additional protection and exclusivity for our drug combinations with REQORSA and furthering our patent protection in the Asian markets where lung cancer is the most prevalent," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex.

According to GLOBOCAN, in 2022 Asia accounted for 63% of new lung cancer cases worldwide, which is equal to more than 1.5 million new cases of lung cancer per year. In 2022, China alone had more than 1 million new cases of lung cancer.

The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech's Tecentriq^® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who developed tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 clinical trial has received U.S. Food and Drug Administration (FDA) Fast Track Designation for this patient population, and Acclaim-3 has received FDA Orphan Drug Designation.

About Genprex, Inc.

Genprex, Inc. 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. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex^® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa^® Gene Therapy (quaratusugene ozeplasmid), is currently being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

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Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2023.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

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