Data from Genprex's Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer
Genprex (NASDAQ: GNPX) reported publication of Acclaim-1 Phase 1 data in Clinical Lung Cancer on Nov 24, 2025, evaluating REQORSA (quaratusugene ozeplasmid) with osimertinib in advanced EGFR-mutant NSCLC after progression on prior osimertinib.
The Phase 1 dose-escalation (12 patients) found no dose-limiting toxicities, set a recommended Phase 2 dose (RP2D) of 0.12 mg/kg, and reported early signs of efficacy including one investigator-assessed partial remission continuing >32 months and two patients with prolonged progression-free survival.
Genprex (NASDAQ: GNPX) ha riferito la pubblicazione dei dati di Fase 1 di Acclaim-1 su Clinical Lung Cancer il 24 novembre 2025, valutando REQORSA (quaratusugene ozeplasmid) insieme a osimertinib in NSCLC avanzato con mutazione EGFR dopo progressione su osimertinib precedente.
La fase 1 di escalation della dose (12 pazienti) ha rilevato assenza di tossicità dose-limitante, ha definito una dose consigliata per la fase 2 (RP2D) pari a 0,12 mg/kg e ha riportato primi segnali di efficacia, tra cui una remissione parziale valutata dall'investigatore che persiste >32 mesi e due pazienti con sopravvivenza senza progressione prolungata.
Genprex (NASDAQ: GNPX) informó la publicación de los datos de la Fase 1 de Acclaim-1 en Clinical Lung Cancer el 24 de noviembre de 2025, evaluando REQORSA (quaratusugene ozeplasmid) con osimertinib en NSCLC avanzado con mutación EGFR tras progresión con osimertinib previo.
La dosis de escalamiento de la Fase 1 (12 pacientes) no encontró toxicidad dosis limitante , estableció una dosis recomendada de la Fase 2 (RP2D) de 0,12 mg/kg, y reportó primeros signos de eficacia, incluida una remisión parcial evaluada por el investigador que continúa >32 meses y dos pacientes con supervivencia libre de progresión prolongada.
Genprex (NASDAQ: GNPX)은 Acclaim-1 1상 데이터가 2025년 11월 24일 Clinical Lung Cancer에 게재되었다고 발표했으며, REQORSA (quaratusugene ozeplasmid)와 오시머티닙(osimertinib)을 진행된 EGFR 변이 NSCLC에서 이전 오시머티닙 진행 후 평가하였다.
1상 용량증강(12명)에서는 용량제한독성(DLT) 없음을 발견했고, 1상에서 2상 권고용량(RP2D) 0.12 mg/kg을 제시했으며, 조사자 평가 부분 반응이 32개월 이상 지속된 사례 1건과 무진행생존기간(PFS)을 연장한 2명의 환자를 포함한 초기 유효성 신호를 보고했다.
Genprex (NASDAQ: GNPX) a publié les données de la phase 1 d'Acclaim-1 dans Clinical Lung Cancer le 24 novembre 2025, évaluant REQORSA (quaratusugene ozeplasmid) avec osimertinib dans un NSCLC avancé muté EGFR après progression sous osimertinib préalable.
La phase 1 d'escalade de dose (12 patients) a montré aucune toxicité limitant la dose, a fixé une dose recommandée pour la phase 2 (RP2D) de 0,12 mg/kg et a rapporté des signes précoces d'efficacité, dont une rémission partielle évaluée par l'investigateur qui se poursuit depuis >32 mois et deux patients avec une survie sans progression prolongée.
Genprex (NASDAQ: GNPX) meldete die Veröffentlichung der Acclaim-1 Phase-1-Daten in Clinical Lung Cancer am 24. November 2025, in der REQORSA (quaratusugene ozeplasmid) mit Osimertinib bei fortgeschrittenem EGFR-mutiertem NSCLC nach Progression unter vorherigem Osimertinib bewertet wurde.
Die Phase-1-Dosiseskalation (12 Patienten) fand keine dosislimitierenden Toxizitäten, setzte eine empfohlene Phase-2-Dosis (RP2D) von 0,12 mg/kg fest und berichtete erste Anzeichen von Wirksamkeit, einschließlich einer vom Untersucher beurteilten partiellen Remission, die >32 Monate anhält, sowie zwei Patienten mit verlängertem progressionsfreiem Überleben.
Genprex (NASDAQ: GNPX) أبلغت عن نشر بيانات المرحلة 1 من Acclaim-1 في Clinical Lung Cancer في 24 نوفمبر 2025، تقيم REQORSA (quaratusugene ozeplasmid) مع osimertinib في NSCLC متقدم مع طفرة EGFR بعد التقدم على osimertinib سابقاً.
وجدت جرعة-تصعيد المرحلة 1 (12 مريضاً) عدم وجود سمّيات مقيدة للجرعة، وحددت جرعة موصى بها للمرحلة 2 (RP2D) قدرها 0.12 mg/kg، وأبلغت عن إشارات مبكرة للفعالية بما في ذلك وجود استجابة جزئية بحسب تقييم المحقق تستمر لأكثر من 32 شهراً واثنان من المرضى مع بقاء التصاعدي المتقدم ممتد.
- No DLTs observed in Phase 1 dose escalation
- Established RP2D 0.12 mg/kg (highest dose tested)
- One patient with partial remission continuing >32 months (47 cycles)
- Early efficacy seen in 3 patients despite prior osimertinib progression
- Small cohort of 12 patients limits generalizability
- Delayed infusion-related reactions (muscle aches, fever, chills) required prophylactic steroids, acetaminophen, diphenhydramine
Insights
Phase 1 publication reports a clean safety profile and early, durable responses for REQORSA plus osimertinib in advanced EGFR‑mutant NSCLC.
Genprex published Phase 1 data showing no Dose Limiting Toxicities and an established Recommended Phase 2 Dose of 0.12 mg/kg for REQORSA given with osimertinib. Of 12 treated patients who had progressed on prior osimertinib regimens, three showed extended disease control, including one ongoing investigator‑assessed partial remission after more than
The key business mechanism is clear: the program advanced from dose‑escalation to an identified RP2D with a tolerability profile that permits repeat dosing; this de‑risking at Phase 1 supports continued clinical development and potential value capture if later trials confirm benefit. Material dependencies include confirmatory efficacy in larger cohorts, durability across more patients, and management of the reported delayed infusion‑related reactions; steroids and premedication reportedly mitigated those events. Watch for publication details and follow‑up data in the Phase 1/2 expansion and any announced timelines for additional cohorts or endpoints over the next 12–24 months.
Phase 1 Study in Non-Small Cell Lung Cancer Combined Reqorsa® Gene Therapy with Tagrisso®
"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.
To read the article published in Clinical Lung Cancer, click here.
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, its intended regulatory submissions and any resulting regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; including as a potential treatment for patients with late-stage NSCLC with activating EGFR mutations whose disease progressed after treatment with osimertinib; 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; Genprex's intellectual property and licenses; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates.
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.
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FAQ
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