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Genprex In-Licenses Additional Gene Therapy Technologies for Treatment of Lung Cancer

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Genprex, Inc. (GNPX) announced an amendment to its License Agreement with a major cancer research center in Houston, granting the company an exclusive worldwide license for six patents and one patent application. The Newly Licensed IP aims to enhance treatment for non-small cell lung cancer (NSCLC) by combining TUSC2 therapy with EGFR inhibitors or other therapies. The lead candidate, REQORSA™, has been granted Fast Track Designation by the FDA for NSCLC in conjunction with Tagrisso. Genprex is set to launch Acclaim-1 and Acclaim-2 clinical trials combining REQORSA with other therapies.

Positive
  • Exclusive license for six additional patents enhances Genprex's IP portfolio.
  • REQORSA™ has received FDA Fast Track Designation, indicating promising potential.
  • Upcoming Acclaim-1 and Acclaim-2 clinical trials aim to combine REQORSA with established therapies for NSCLC.
Negative
  • None.

Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing technologies for patients with cancer and diabetes, today announced that the Company and a major cancer research center in Houston, Texas, in March 2021, entered into an amendment (the “Amendment”) to their May 2020 License Agreement (the “License Agreement”) to grant to Genprex an exclusive worldwide license to an additional portfolio of six patents and one patent application and related technology (“Newly Licensed IP”). The Newly Licensed IP includes methods for treating non-small cell lung cancer (NSCLC) by administration of a TUSC2 therapeutic in conjunction with EGFR inhibitors or other anti-cancer therapies, in patients who are predicted to be responsive to TUSC2 therapy. A TUSC2 gene-expressing plasmid is the active agent in REQORSA™ immunogene therapy, Genprex’s lead drug candidate.

“We are pleased to continue optimizing and expanding our world-class intellectual property portfolio with the addition of these technologies,” said Rodney Varner, President and Chief Executive Officer of Genprex. “These new technologies further add to our arsenal of combination therapies for REQORSA, and may enable us to improve patient outcomes through the advancement of multiple therapeutic approaches.”

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. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso.

The Company is preparing to initiate its Acclaim-1 and Acclaim-2 clinical trials for the treatment of NSCLC. Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines REQORSA with AstraZeneca’s Tagrisso in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial will combine REQORSA with Merck & Co’s Keytruda for late stage NSCLC patients whose disease progressed after treatment with Keytruda.

For more information, please visit the Company’s web site at www.genprex.com or follow 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. Th

FAQ

What is the significance of Genprex's new patent license related to GNPX?

Genprex's new patent license enhances its treatment options for NSCLC, potentially improving patient outcomes.

What is REQORSA™ and its role in GNPX's therapies?

REQORSA™ is Genprex's lead drug candidate designed to treat NSCLC, now enhanced by additional patented technologies.

What trials are being initiated by Genprex for its NSCLC treatment?

Genprex is initiating Acclaim-1 and Acclaim-2 clinical trials, which will evaluate REQORSA in combination with existing therapies.

When was Fast Track Designation granted for REQORSA™ by the FDA?

The FDA granted Fast Track Designation for REQORSA™ in January 2020.

What combination therapies is Genprex pursuing for REQORSA™ in NSCLC?

Genprex is pursuing combination therapies of REQORSA™ with AstraZeneca's Tagrisso and Merck's Keytruda.

Genprex, Inc.

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