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Genprex Announces Preclinical Data for TUSC2 Immunogene Therapy in Non-Small Cell Lung Cancer to Be Featured in Two Presentations at the 2021 American Association for Cancer Research Annual Meeting

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Genprex has announced that preclinical data on TUSC2 immunogene therapy (REQORSA™) will be presented at the AACR 21 meeting from April 9-14, 2021. This therapy aims to improve treatment outcomes for non-small cell lung cancer (NSCLC) by enhancing the efficacy of chemotherapy and overcoming resistance to osimertinib. The upcoming Acclaim-1 and Acclaim-2 clinical trials will evaluate REQORSA in combination with AstraZeneca’s Tagrisso® and Merck's Keytruda®. The presentations are expected to attract attention from leading cancer researchers.

Positive
  • Preclinical data presentation at AACR 21 highlights REQORSA's potential in NSCLC treatment.
  • Acclaim-1 and Acclaim-2 clinical trials are set to evaluate REQORSA's efficacy in combination with leading therapies.
Negative
  • None.

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 preclinical data of its TUSC2 immunogene therapy (REQORSA™) in combination with chemotherapy and immunotherapies, as well as in combination with targeted therapies to overcome resistance to osimertinib, for the treatment of non-small cell lung cancer (NSCLC), will be featured in two presentations at the upcoming annual meeting of the American Association for Cancer Research (AACR 21) taking place virtually from April 9-14, 2021.

“We look forward to the presentation of these data that highlight the potential of TUSC2 immunogene therapy to enhance chemo-immune combination treatments and overcome resistance to osimertinib in lung cancer, to an audience of the world’s leading cancer researchers,” said Rodney Varner, President and Chief Executive Officer of Genprex. “As lung cancer is the leading cause of cancer deaths worldwide, we remain keenly focused on initiating our Acclaim-1 and Acclaim-2 clinical trials to evaluate REQORSA, our proprietary TUSC2 immunogene therapy, in non-small cell lung cancer.”

Acclaim-1 is a Phase 1/2 combination clinical trial using REQORSA combined with AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. Acclaim-2 is a Phase 1/2 combination clinical trial using REQORSA combined with Merck & Co’s Keytruda® (pembrolizumab) in NSCLC patients who are low expressors of PD-L1.

Featured Genprex-supported abstracts to be presented at AACR 21 include:

 

 

Oral Presentation

 

Session:

MS.IM02.02 - Overcoming Resistance in the Tumor Microenvironment: Novel Immunomodulatory Agents

Title:

“TUSC2 immunogene therapy enhances efficacy of chemo-immune combination therapy and induces robust antitumor immunity in KRAS-LKB1 mutant NSCLC in humanized mice”

Poster Number/Channel:

#76/Channel 03

Presentation Date/Time:

April 10, 2021 from 2:50-3:00 p.m. ET

Presenters:

Ismail M. Meraz, Mourad Majidi, RuPing Shao, Feng Meng, Min Jin Ha, Elizabeth Shpall, Jack A. Roth. University of Texas MD Anderson Cancer Center, Houston, TX

 

Poster Presentation:

 

 

 

Session:

PO.ET03.01 - Drug Resistance in Molecular Targeted Therapies

Title:

“Overcoming resistance to osimertinib by TUSC2 gene therapy in EGFR mutant NSCLC”

Poster Number:

#1105

Presentation Date/Time:

April 10, 2021 from 8:30 a.m. - 11:59 p.m. ET

Presenters:

Ismail M. Meraz, Mourad Majidi, RuPing Shao, Lihui Gao, Meng Feng, Huiqin Chen, Min Jin Ha, Jack A. Roth. University of Texas MD Anderson Cancer Center, Houston, TX

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 osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

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. Because such 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 the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of REQORSA™ immunogene therapy drug, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of REQORSA and our other potential product candidates including whether we receive or benefit from fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

FAQ

What is the focus of Genprex's clinical trials involving GNPX?

Genprex's clinical trials focus on evaluating the effectiveness of REQORSA™ immunogene therapy in combination with other therapies for non-small cell lung cancer.

When will the preclinical data for REQORSA be presented?

The preclinical data for REQORSA will be presented at the AACR 21 meeting, scheduled for April 10, 2021.

What is TUSC2 immunogene therapy and its significance for NSCLC?

TUSC2 immunogene therapy aims to enhance treatment efficacy for NSCLC patients, potentially improving outcomes in combination with chemotherapy and targeted therapies.

What are the primary goals of the Acclaim-1 and Acclaim-2 trials for GNPX?

The Acclaim-1 and Acclaim-2 trials aim to assess the effectiveness of REQORSA in overcoming resistance to osimertinib and enhancing the efficacy of Keytruda in NSCLC.

Genprex, Inc.

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