• Provides Additional Protection in Large Markets for Therapeutic Combination in Acclaim-2 Phase 1/2 Clinical Trial
•  Patent Already Granted for Same Combination in U.S. Japan, Australia, Russia and Mexico

AUSTIN, Texas, July 5, 2023 /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 China National Intellectual Property Administration has granted Genprex China Patent No: 201780076886.X. The broad patent covers the use of Genprex's lead drug candidate, REQORSA^® Immunogene Therapy, in combination with PD1 antibodies through 2037.

"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.

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 proprietary, non-viral ONCOPREX^® Nanoparticle 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^® (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Each of Genprex's three lung cancer clinical programs have received a Fast Track Designation from the Food and Drug Administration. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an adeno-associated virus (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 are 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.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.

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; 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 continue 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.

Genprex, Inc.
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