Genprex Publishes Positive Phase 1 Data on LNP-Delivered Gene Therapy for Advanced Lung Cancer

AUSTIN, Texas – November 24, 2025- Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, today announced the publication of promising safety and early efficacy data from the Phase 1 portion of its Acclaim-1 clinical trial. The study evaluated Reqorsa® Gene Therapy (quaratusugene ozeplasmid), a novel plasmid DNA construct delivered by Lipid Nanoparticles (LNPs), in combination with Tagrisso® (osimertinib) for patients with advanced, osimertinib-resistant non-small cell lung cancer (NSCLC). The results, highlighting the therapeutic potential of this plasmid-LNP system, were published in the peer-reviewed journal Clinical Lung Cancer.

Reqorsa is a first-in-class non-viral plasmid gene therapy. The therapeutic plasmid DNA, which encodes the TUSC2 tumor suppressor gene, is encapsulated in an LNP for targeted delivery to cancer cells. The use of LNPs provides a crucial non-viral delivery system that shields the fragile plasmid from degradation, facilitates targeting, and enables entry into the cancer cells. This mechanism marks a distinct and innovative approach to cancer treatment, advancing the field of plasmid medicine.

“We believe REQORSA is an innovative plasmid gene therapy, utilizing the powerful LNP delivery platform, that may benefit many lung cancer patients,” said Ryan Confer, President and Chief Executive Officer at Genprex. “We believe this new mechanism and novel approach targeting lung cancer, which comes with a strong safety profile and early signs of efficacy, is paving new ground in the fight against lung cancer with a therapeutic plasmid delivered by LNP.”

LNP-Delivered Plasmid Targets Treatment-Resistant Lung Cancer

The Acclaim-1 trial specifically enrolls patients with late-stage NSCLC whose disease has progressed following prior osimertinib treatment—a population with high unmet clinical need.

The Phase 1 dose escalation primarily focused on safety and established an excellent profile for the LNP-delivered plasmid therapy:

• Safety Profile: The trial reported no Dose Limiting Toxicities (DLTs).

• Recommended Dose: A Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (LNP-plasmid dose) was successfully established.

• Tolerability: Reqorsa administration, involving the plasmid LNP construct, was generally well tolerated. Mild, transient infusion-related reactions were observed, which are similar to those seen with common oncology biologics, and were managed with standard prophylactic medications.

Prolonged Benefit Observed with Reqorsa LNP Plasmid Therapy

Of the 12 patients treated with Reqorsa (the LNP-encapsulated plasmid) and osimertinib, notable signs of clinical benefit were observed, particularly the durable responses in patients who had already failed prior osimertinib regimens:

• Long-Term Partial Response: One patient receiving the 0.06 mg/kg LNP-plasmid dose achieved a partial remission and remained on treatment for 47 cycles over 32 months as of the data cutoff.

• Extended Stable Disease: Another patient, treated at the RP2D of 0.12 mg/kg LNP-plasmid therapy, maintained stable disease for approximately 24 months.

These instances of extended Progression Free Survival (PFS) are considered highly encouraging in this heavily pre-treated population, suggesting that the plasmid-based therapy is overcoming resistance mechanisms typically seen with single-agent osimertinib after progression. The successful clinical deployment of the LNP platform in this trial validates its potential as a superior non-viral method for delivering genetic medicines like plasmid DNA to solid tumors.

The publication provides a strong foundation for the continuation of the Acclaim-1 trial into its Phase 2 stage.