Genprex Inc. (NASDAQ: GNPX) Announces Positive Data From Phase 1 Clinical Trial Evaluating REQORSA(R) Immunogene Therapy for Late-Stage Non-Small Cell Lung Cancer

• The positive data from the Acclaim-1 Phase 1 portion of the Phase 1/2 clinical trial has been published in an abstract at the 2023 American Society of Clinical Oncology Annual Meeting, which took place in Chicago, IL and online June 2 – 6, 2023
• Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA(R) in combination with Tagrisso(R)
• The Phase 2 expansion portion of the study is expected to enroll approximately 66 patients – half of which will have only received Tagrisso(R) and the other half receiving Tagrisso(R) and chemotherapy
• The global lung cancer treatment market is expected to grow to $48.7 billion by 2026

Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, recently announced that positive data from the Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA(R) Immunogene Therapy in combination with Tagrisso(R) in late-stage non-small cell lung cancer (“NSCLC”) have been published in an abstract at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting, which took place June 2-6, 2023 at McCormick Place in Chicago, IL, and online (https://ibn.fm/tzmZS).

The preliminary results from eight patients show that the combination of REQORSA and Tagrisso was well tolerated at all three dose levels of the Phase 1 trial, with encouraging evidence of efficacy observed. “We are thrilled to have our abstract, which reports positive results from the Phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual meeting,” said Mark Berger, MD, Chief Medical Officer at Genprex. “We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed.  These data supported the Safety Review Committee’s approval of our advancement to the Phase 2 expansion portion of the clinical trial, which we expect to begin in the third quarter.”

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the company’s lead drug candidate in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor mutations whose disease progressed after treatment with Tagrisso. The dose escalation Phase 1 portion of the Acclaim-1 clinical trial has been completed, and the Phase 2 expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment – the other half will have received Tagrisso and chemotherapy treatments.

Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies to provide novel treatment approaches, which includes its lead product candidate REQORSA Immunogene Therapy. REQORSA consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules with a positive electrical charge. The drug candidate is injected intravenously and targets cancer cells.

Developing resistance to drugs like Tagrisso, Keytruda, and Tecentriq is inevitable for many cancer patients. In addition, the average five-year lung cancer survival rate is 18.6%, which highlights the importance of REQORSA’s potential in the global lung cancer industry, which is expected to grow to $48.7 billion by 2026 (https://ibn.fm/8Eqy0).

“It is encouraging that several patients whose disease was progressing on their previous therapy are now having long periods of response and stable disease in the Phase 1 portion of the study,:” said Rodney Varner, Chairman, President, and Chief Executive Officer of Genprex. “We wish to thank the patients and investigators participating in our clinical trials and our investors who make it possible to move our drug candidates forward toward regulatory approval for patients in need.”

For more information, visit the company’s website at www.Genprex.com.

NOTE TO INVESTORS: The latest news and updates relating to GNPX are available in the company’s newsroom at http://ibn.fm/GNPX

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