• Expands on the previously granted patents covering the use of REQORSA in combination with immune checkpoint inhibitors applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials

AUSTIN, Texas, March 12, 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 Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex's lead drug candidate, Reqorsa® Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037.

This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1 inhibitors. These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials.

"We continue to secure exclusivity for our drug combinations of REQORSA with PD-1 antibodies, such as Keytruda® and PD-L1 antibodies, such as Tecentriq®, for the treatment of cancer in some of the largest markets," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "It is important that we continue to add to our global intellectual property estate and to build protection around our drug combinations as we advance REQORSA through the clinic."

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.'s Keytruda® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024. Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population.

The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech's Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population.

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 nanoparticles. 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® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three 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-003 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, 2022.

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; 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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