• Impressive Video Released on Positive Clinical Results with Promising

• Chief Medical Officer Provides Overview of Recent Positive Clinical Patient Outcomes in New Video Presentation.

• Clinical Trial on Combination of Reqorsa® Gene Therapy, and AstraZeneca's Tagrisso® to Treat Late-Stage Non Small Cell Lung Cancer. 

• Patent Granted in Singapore for Reqorsa® Gene Therapy with PD-1 Antibodies to Treat Cancers.  

Genprex, Inc. (Nasdaq: GNPX) is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. GNPX 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. GNPX 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 GNPX oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. 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 GNPX lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of GNPX lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and the GNPX SCLC program has received an FDA Orphan Drug Designation. The GNPX 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-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

New Video Featuring GNPX Chief Medical Officer Discussing Positive Patient Outcomes in Two Lung Cancer Clinical Trials

On August 15th GNPX released a new video featuring the Company's Chief Medical Officer, Mark Berger, MD, discussing positive clinical study updates from its Acclaim-1 and Acclaim-3 Phase 1/2 clinical trials in lung cancer and recent updates to the GNPX oncology clinical development program.

To watch the video, visit the GNPX website at: https://www.genprex.com/videos/.

The Acclaim-1 clinical trial is evaluating the combination of the GNPX lead drug candidate, Reqorsa® Gene Therapy, and AstraZeneca's Tagrisso® to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso.

The Acclaim-3 clinical trial is evaluating the combination of REQORSA and GNPX Tecentriq® as a maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

Dr. Berger remarked on the two positive patient outcomes in Acclaim-1:

"Both of these patients' outcomes are fairly remarkable in terms of their prolonged Progression Free Survival (PFS) among patients in the study who were progressing on their previous treatment when they came into the study. It's very compelling, particularly, that one of those patients has maintained this benefit for more than two years. And over time, the patients' side effects with the combination of REQORSA and Tagrisso have diminished rather than increased over time."

Dr. Berger's commentary on the positive patient outcome in Acclaim-3:

"In the Acclaim-3 study, the first patient treated in the Phase 1 dose escalation portion of the trial has had a positive response since enrollment and starting maintenance therapy. The patient has a partial remission (PR) from the start of maintenance therapy until after the second course, which is when the first CT scan is done. This is the first dose group in this study, and there is a second higher dose group to come. The patient's response is remarkable, and it is very unusual to have a PR during maintenance therapy. We believe these results bode very well for the study."

On recent updates to the GNPX oncology clinical development program, Dr. Berger stated:

"To build on these positive patient results, we are making changes to our clinical development program both in the Acclaim-1 and Acclaim-2 studies. In the Acclaim-1 study, we are removing one of the cohorts in Phase 2a, which will allow us to advance more quickly. The Acclaim-2 study is being closed to further enrollment. It has been slow to enroll patients, mainly because there are hundreds of other very similar studies that evaluate new treatments after patients have progressed on Keytruda®.” 

Patent Granted in Singapore for GNPX Reqorsa® Gene Therapy with PD-1 Antibodies to Treat Cancers

On August 13th GNPX announced that the Singapore Patent Office has granted a patent that covers the use of the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with anti-PD-1 antibodies through 2037.

This GNPX patent expands on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile, China and Korea to cover the use of REQORSA in combination with an immune checkpoint inhibitor, i.e., PD-1 antibodies. The granted Korean patent also claims the use of REQORSA in combination with PD-L1 antibodies. GNPX will be pursuing additional patent applications with claims to combinations of REQORSA and PD-L1 antibodies in the US, Brazil, Canada, China, Europe and Israel. Should these applications grant, they would be applicable to Genprex's Acclaim-3 clinical trial.

PD-1 inhibitors and PD-L1 inhibitors are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.

For more information on $GNPX visit: www.genprex.com and https://compasslivemedia.com/gnpx/

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Company Name: Genprex, Inc.
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Website: https://www.genprex.com/