Genprex to Present Trial Design of Acclaim-3 Clinical Trial Evaluating Reqorsa® Gene Therapy in Small Cell Lung Cancer at 2025 ASCO Annual Meeting

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Genprex (NASDAQ: GNPX) will present the trial design of its Acclaim-3 Phase 1/2 clinical trial at the 2025 ASCO Annual Meeting. The trial evaluates Reqorsa® Gene Therapy in combination with Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC). The study aims to improve the current median progression-free survival of 2.6 months in ES-SCLC patients. The trial's Phase 2 portion, which began enrollment in December 2024, will include 50 patients and targets a median PFS of approximately 4.3 months. The presentation will take place on May 31, 2025, featuring research showing that TUSC2, a tumor suppressor gene, is decreased in 100% of SCLC patients and absent in 41% of cases. Preclinical studies demonstrated that the Reqorsa-Tecentriq combination significantly increased tumor cell killing compared to Tecentriq alone.

Insights

Oncology Clinical Trial Expert

Genprex will present its Acclaim-3 trial design targeting TUSC2 deficiency in small cell lung cancer at ASCO 2025, showing scientific rationale but no results yet.

Genprex's upcoming poster presentation at ASCO 2025 highlights the trial design for Acclaim-3, a Phase 1/2 study evaluating Reqorsa® Gene Therapy in combination with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC). The scientific rationale is compelling—Reqorsa delivers the TUSC2 tumor suppressor gene, which is decreased in 100% of SCLC patients and completely absent in 41%.

The trial targets a significant unmet need. While Tecentriq maintenance therapy has improved outcomes in ES-SCLC, the median progression-free survival (PFS) remains only 2.6 months. The Phase 2 portion is powered to detect improvement to 4.3 months median PFS, which would represent a 65% improvement.

Preclinical evidence in xenograft models shows the Reqorsa-Tecentriq combination significantly increased tumor killing versus Tecentriq alone, with improved immune cell infiltration and decreased myeloid-derived suppressor cells—suggesting potential synergy with immunotherapy.

The trial has completed Phase 1 dose-escalation (0.09 and 0.12 mg/kg cohorts) and advanced to Phase 2 in December 2024, enrolling 50 patients. This presentation represents standard progress reporting rather than efficacy data. Investors should recognize this is an early-to-mid stage trial in a challenging cancer type, with efficacy results still pending. The scientific approach is rational but success remains uncertain without clinical outcomes data.

Presentation to Highlight Genprex's Study of Reqorsa^® Gene Therapy in Combination with Tecentriq^® for the Treatment of Extensive Stage Small Cell Lung Cancer

AUSTIN, Texas, May 29, 2025 /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 announced that it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois and online.

Genprex's abstract, which is now available on the 2025 ASCO Annual Meeting conference website, was selected for a poster presentation for the Trials in Progress portion of the conference. The Company will present the trial design of the Acclaim-3 Phase 1/2 clinical trial evaluating Genprex's lead drug candidate, Reqorsa^® Gene Therapy (quaratusugene ozeplasmid), in combination with Tecentriq^® as maintenance therapy for the treatment of extensive stage small cell lung cancer (ES-SCLC).

"We are proud of the work that has gone into our Phase 1/2 Acclaim-3 clinical trial evaluating our lead drug candidate, REQORSA, in combination with AstraZeneca's Tecentriq," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe that by reintroducing the TUSC2 gene, a tumor suppressor gene that is decreased in 100% of SCLCs, we have an opportunity to improve on the median progression free survival rate of only 2.6 months in an effort to help these patients extend their lives and potentially improve their prognosis."

Below are the details for Genprex's poster presentation at the 2025 ASCO Annual Meeting:

Title: A phase 1/2 clinical trial of quaratusugene ozeplasmid gene therapy and atezolizumab maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC)
Session Type: Poster Session
Presentation Date: Saturday, May 31, 2025
Presentation Time: 1:30 – 4:30 p.m. CT
Presenter: Bo Wang, MD, Oncology Associates of Oregon

The featured Genprex-supported abstract to be presented for poster presentation at the 2025 ASCO Annual Meeting:

The addition of Tecentriq (atezolizumab) to both induction therapy and maintenance therapy for patients with ES-SCLC has improved median progression free survival (PFS) and overall survival. However, the median PFS from starting Tecentriq maintenance is only 2.6 months. Expression of TUSC2, a tumor suppressor gene, is absent in 41% of SCLC patients and is decreased in 100% of SCLC patients. Reoqrsa^® Gene Therapy (quaratusugene ozeplasmid) consists of a DNA plasmid expressing the TUSC2 gene encapsulated in a positively charged lipoplex which delivers the TUSC2 gene to cancer cells, restoring TUSC2 expression. Xenograft studies using a SCLC cell line in a humanized mouse model treated with a combination of REQORSA and Tecentriq demonstrated significantly increased tumor cell killing compared to that of Tecentriq alone. In addition, infiltration of immune cells was increased in the tumor tissue, whereas myeloid derived suppressor cells were decreased. Thus, in this study REQORSA is added to Tecentriq maintenance therapy with the aim of improving PFS after the start of maintenance therapy. 

Eligible patients have ES-SCLC and have completed 3-4 cycles of induction therapy with etoposide, a platinum agent, and Tecentriq without disease progression, and are thus eligible for maintenance therapy. REQORSA is administered via IV every 21 days in escalating dose cohorts in Phase 1 and Tecentriq 1200 mg is also administered via IV every 21 days. Dexamethasone, acetaminophen, and diphenhydramine are given prior to each treatment to prevent delayed infusion-related reactions. Efficacy is evaluated after every even cycle of treatment using RECIST 1.1 criteria. Safety is evaluated using CTCAE v5, with dose limiting toxicities generally defined as ≥Gr 3 adverse events (AEs). TUSC2 protein expression is measured by a validated immunohistochemistry assay in paraffin sections to determine if PFS is related to pretreatment TUSC2 levels. A validated assay measures pharmacokinetics in all patients. In Phase 1, two planned dose levels (0.09, and 0.12 mg/kg) of REQORSA were administered, and a standard dose escalation with 3-6 patients/dose level was used. The Phase 2 portion of the trial will enroll 50 patients which provides 80% power at a one-sided alpha level of 0.05 to detect an 18-week PFS rate of 52% compared to a historical 18-week PFS rate of 34% with Tecentriq alone. This corresponds to a median PFS of approximately 4.3 months compared to a historical median PFS of 2.6 months with Tecentriq alone. A Safety Review Committee (SRC) reviewed safety data at the end of each dose level of Phase 1 to make recommendations about dose escalation. The Phase 2 portion of the trial opened for enrollment in December 2024.

Following the poster presentation, a copy of the poster will be made available on Genprex's website.

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 for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following 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. 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, 2024.

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: 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 strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, 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.

Genprex, Inc.
(877) 774-GNPX (4679)

GNPX Investor Relations
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SOURCE Genprex, Inc.

FAQ

What is the purpose of Genprex's Acclaim-3 clinical trial for GNPX stock?

The Acclaim-3 trial evaluates Reqorsa® Gene Therapy combined with Tecentriq® as maintenance therapy for extensive stage small cell lung cancer, aiming to improve the current median progression-free survival of 2.6 months.

When will Genprex (GNPX) present at ASCO 2025 and what will they discuss?

Genprex will present on May 31, 2025, from 1:30-4:30 PM CT, discussing the trial design of Acclaim-3 Phase 1/2 clinical trial for Reqorsa® Gene Therapy in small cell lung cancer.

How many patients will be enrolled in Phase 2 of GNPX's Acclaim-3 trial?

The Phase 2 portion will enroll 50 patients, providing 80% power to detect an 18-week PFS rate of 52% compared to 34% historical rate with Tecentriq alone.

What is the significance of TUSC2 gene in Genprex's GNPX Reqorsa therapy?

TUSC2 is a tumor suppressor gene that is decreased in 100% of SCLC patients and absent in 41%. Reqorsa aims to restore TUSC2 expression in cancer cells.

When did Phase 2 of Genprex's Acclaim-3 trial begin enrollment?

The Phase 2 portion of the Acclaim-3 trial opened for enrollment in December 2024.