On November 24, 2025 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, reported the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.
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"We believe REQORSA is an innovative gene therapy that may benefit many lung cancer patients, and we are pleased to see these data for REQORSA published and shared with the scientific community," said Ryan Confer, President and Chief Executive Officer at Genprex. "Genprex is thankful to the patients who participated in this study, along with the investigators who made the completion of the study possible. 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."
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with osimertinib in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with osimertinib (osimertinib monotherapy or osimertinib combination therapy).
The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib.
Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.
Specifically, one patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed and osimertinib, had a partial remission by investigator evaluation, and as of the data from April 2025 used in the published manuscript had continued to receive study treatment for 47 cycles over 32 months. The patient continues to receive REQORSA and osimertinib treatment in the trial more than three years after enrolling.A second patient at the 0.12 mg/kg dose level who was previously treated with cisplatin, pemetrexed, carboplatin and osimertinib had stable disease and received REQORSA for 32 cycles, or approximately 24 months, until disease progression occurred.
A third patient who was at the 0.09 mg/kg dose level, previously treated with osimertinib, had stable disease and received 14 cycles over approximately 10 months before disease progression occurred.
The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib.
REQORSA administration was generally well tolerated and there were no DLTs. The administration was associated with a delayed infusion-related reaction of muscle aches, fever and chills in some patients, which we believe is similar to reactions seen with the administration of antibodies routinely used in oncology treatment. This was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.
(Press release, Genprex, NOV 24, 2025, View Source [SID1234660897])