Chief Medical Officer Provides Overview of Recent Positive Clinical Patient Outcomes
Video Highlights Recent Oncology Clinical Development Program Updates
AUSTIN, Texas, Aug. 15, 2024 /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 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 Company's oncology clinical development program.
The Acclaim-1 clinical trial is evaluating the combination of the Company's 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 Genentech's 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 Company's 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®. We certainly intend to continue to treat patients in this study until they have disease progression. We also believe closing to further enrollment is the right thing to do so that we can focus our limited resources on the fastest way to being able to enroll patients and get clinical data.
We're very excited by these positive patient responses, and we look forward to advancing REQORSA through the clinic. We believe that streamlining our efforts to do so is the best way to use our resources and to move our program forward."
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 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 Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's 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.
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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, 2023.
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: the initial patient responses to REQORSA treatments and the potential and promise of these responses, which are demonstrating early evidence of efficacy with a favorable safety profile; Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; 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; the effects of any strategic research and development prioritization initiatives, and any other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and 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.
