Genprex Collaborators Report Positive Preclinical Data on the Use of Reqorsa® Gene Therapy for the Treatment of Ras Inhibitor Resistant Lung Cancer at the 2025 AACR Annual Meeting
Genprex announced positive preclinical data for their Reqorsa® Gene Therapy in treating Ras inhibitor resistant lung cancer at the 2025 AACR Annual Meeting in Chicago. The research focused on treating KRASG12C mutant non-small cell lung cancer (NSCLC).
Key findings showed that Reqorsa effectively overcomes resistance to LUMAKRAS® (sotorasib) in NSCLC mouse models. The therapy demonstrated significant results both alone and in combination with sotorasib:
- Reduced colony formation and increased cancer cell death in resistant cell lines
- Decreased viability of resistant organoids
- Showed strong anti-tumor effects in controlling tumor growth
- Achieved synergistic anti-tumor effects when combined with sotorasib
The research suggests Reqorsa's potential as a treatment for Ras inhibitor resistant lung cancer, either as a standalone therapy or in combination with Ras inhibitors.
Genprex ha annunciato dati preclinici positivi per la loro terapia genica Reqorsa® nel trattamento del cancro polmonare resistente agli inibitori di Ras, presentati al meeting annuale AACR 2025 di Chicago. La ricerca si è concentrata sul trattamento del carcinoma polmonare non a piccole cellule (NSCLC) con mutazione KRASG12C.
I risultati principali hanno mostrato che Reqorsa supera efficacemente la resistenza a LUMAKRAS® (sotorasib) nei modelli murini di NSCLC. La terapia ha mostrato risultati significativi sia da sola che in combinazione con sotorasib:
- Riduzione della formazione di colonie e aumento della morte delle cellule tumorali nelle linee cellulari resistenti
- Diminuzione della vitalità degli organoidi resistenti
- Effetti antitumorali marcati nel controllo della crescita tumorale
- Effetti antitumorali sinergici ottenuti in combinazione con sotorasib
La ricerca suggerisce il potenziale di Reqorsa come trattamento per il cancro polmonare resistente agli inibitori di Ras, sia come terapia autonoma che in combinazione con tali inibitori.
Genprex anunció datos preclínicos positivos para su terapia génica Reqorsa® en el tratamiento del cáncer de pulmón resistente a inhibidores de Ras, presentados en la Reunión Anual AACR 2025 en Chicago. La investigación se centró en tratar el cáncer de pulmón no microcítico (NSCLC) con mutación KRASG12C.
Los hallazgos clave mostraron que Reqorsa supera eficazmente la resistencia a LUMAKRAS® (sotorasib) en modelos murinos de NSCLC. La terapia demostró resultados significativos tanto sola como en combinación con sotorasib:
- Reducción de la formación de colonias y aumento de la muerte celular en líneas celulares resistentes
- Disminución de la viabilidad de organoides resistentes
- Fuertes efectos antitumorales en el control del crecimiento tumoral
- Efectos antitumorales sinérgicos logrados al combinarse con sotorasib
La investigación sugiere el potencial de Reqorsa como tratamiento para el cáncer de pulmón resistente a inhibidores de Ras, ya sea como terapia independiente o en combinación con estos inhibidores.
Genprex는 2025년 시카고에서 열린 AACR 연례 회의에서 Ras 억제제 내성 폐암 치료를 위한 Reqorsa® 유전자 치료제의 긍정적인 전임상 데이터를 발표했습니다. 연구는 KRASG12C 돌연변이 비소세포폐암(NSCLC) 치료에 초점을 맞추었습니다.
주요 결과는 Reqorsa가 NSCLC 마우스 모델에서 LUMAKRAS®(sotorasib)에 대한 내성을 효과적으로 극복한다는 것을 보여주었습니다. 이 치료법은 단독 사용과 sotorasib 병용 모두에서 유의미한 결과를 나타냈습니다:
- 내성 세포주에서 집락 형성 감소 및 암세포 사멸 증가
- 내성 오가노이드 생존율 감소
- 종양 성장 억제에 강력한 항종양 효과 확인
- sotorasib과 병용 시 상승적인 항종양 효과 달성
이 연구는 Reqorsa가 Ras 억제제 내성 폐암 치료에 단독 요법 또는 Ras 억제제와 병용하여 활용될 가능성을 시사합니다.
Genprex a annoncé des données précliniques positives concernant leur thérapie génique Reqorsa® pour le traitement du cancer du poumon résistant aux inhibiteurs de Ras, lors de la réunion annuelle AACR 2025 à Chicago. La recherche s’est concentrée sur le traitement du cancer du poumon non à petites cellules (NSCLC) mutant KRASG12C.
Les résultats clés ont montré que Reqorsa surmonte efficacement la résistance à LUMAKRAS® (sotorasib) dans des modèles murins de NSCLC. La thérapie a démontré des résultats significatifs, seule et en combinaison avec le sotorasib :
- Réduction de la formation de colonies et augmentation de la mort cellulaire dans les lignées résistantes
- Diminution de la viabilité des organoïdes résistants
- Forte activité antitumorale dans le contrôle de la croissance tumorale
- Effets antitumoraux synergiques obtenus en combinaison avec le sotorasib
Cette recherche suggère le potentiel de Reqorsa comme traitement du cancer du poumon résistant aux inhibiteurs de Ras, en monothérapie ou en association avec ces inhibiteurs.
Genprex gab positive präklinische Daten für ihre Reqorsa® Gentherapie zur Behandlung von Ras-Inhibitor-resistentem Lungenkrebs auf dem AACR Jahreskongress 2025 in Chicago bekannt. Die Forschung konzentrierte sich auf die Behandlung von KRASG12C-mutiertem nicht-kleinzelligem Lungenkrebs (NSCLC).
Wichtige Ergebnisse zeigten, dass Reqorsa die Resistenz gegen LUMAKRAS® (Sotorasib) in NSCLC-Mausmodellen effektiv überwindet. Die Therapie zeigte sowohl allein als auch in Kombination mit Sotorasib signifikante Resultate:
- Verringerte Koloniebildung und erhöhte Krebszellsterblichkeit in resistenten Zelllinien
- Reduzierte Lebensfähigkeit resistenter Organoide
- Starke antitumorale Effekte bei der Kontrolle des Tumorwachstums
- Synergistische antitumorale Effekte bei Kombination mit Sotorasib
Die Forschung deutet auf das Potenzial von Reqorsa als Behandlung für Ras-Inhibitor-resistenten Lungenkrebs hin, sowohl als Monotherapie als auch in Kombination mit Ras-Inhibitoren.
- Preclinical data shows REQORSA effectively overcomes LUMAKRAS resistance in lung cancer treatment
- REQORSA demonstrated strong anti-tumor effects both as standalone and combination therapy
- Data supports potential expansion of future clinical studies pipeline
- Synergistic antitumor effect observed when combining REQORSA with sotorasib in resistant tumors
- REQORSA significantly reduced colony formation and increased apoptosis in resistant cell lines
- Results are only preclinical stage, requiring further clinical trials for validation
- Study limited to specific KRASG12C mutant NSCLC, potentially limiting market application
Insights
Genprex's REQORSA shows promising ability to overcome resistance to KRAS inhibitors in lung cancer, potentially expanding treatment options for resistant tumors.
Genprex's announcement of positive preclinical data for REQORSA in KRASG12C mutant non-small cell lung cancer represents a meaningful scientific advancement. The data demonstrates REQORSA's ability to overcome acquired resistance to sotorasib (LUMAKRAS), addressing a significant challenge in targeted cancer therapy. KRAS mutations occur in approximately 25% of NSCLC cases, but resistance to KRAS inhibitors frequently develops, limiting treatment durability.
The preclinical models showed that REQORSA both as monotherapy and in combination with sotorasib effectively controlled tumor growth in resistant models. Particularly notable is the observed synergistic antitumor effect when combining REQORSA with sotorasib in resistant patient-derived xenograft models. Mechanistically, REQORSA's TUSC2 gene therapy appears to induce apoptosis and inhibit colony formation in resistant cancer cells.
These findings are scientifically significant as they suggest REQORSA could potentially address a critical unmet need in KRAS-mutated lung cancer treatment. The presentation at AACR 2025, a prestigious scientific forum, adds credibility to these results. While these preclinical findings still require validation in human clinical trials, they provide a strong rationale for expanding Genprex's clinical program to include patients with acquired resistance to KRAS inhibitors.
Both REQORSA Alone and in Combination with LUMAKRAS® Demonstrated Robust Anti-Tumor Effects in Ras Inhibitor Resistant Non-Small Cell Lung Cancer
"We are pleased to have this positive preclinical data presented before an audience of the world's leading cancer researchers, which provides further support for the therapeutic potential of REQORSA both alone and in combination with targeted therapies in NSCLC," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe REQORSA could be a potential therapeutic treatment for Ras inhibitor resistant lung cancer either alone or in combination with Ras inhibitors, and these studies support the potential expansion of future clinical studies in our pipeline."
The featured Genprex-supported poster presented at AACR 2025:
Title: Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Resistance in Molecular Targeted Therapies 3
Session Date and Time: Tuesday, April 29 from 2-5 p.m. CT
Location: Poster Section 17
Poster Board Number: 12
Abstract Presentation Number: 5517
In the poster, entitled, "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy," researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib (LUMAKRAS®) acquired resistance (AR) in KRASG12C mutant NSCLC mouse xenografts. The data indicate that TUSC2 transfection significantly reduced colony formation and markedly increased apoptosis in two AR cell lines. Re-expression of TUSC2 in AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib. In conclusion, researchers demonstrated that REQORSA, alone or in combination with sotorasib, induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant sotorasib-acquired resistant xenograft and PDX tumors.
This AACR poster has been made available on Genprex's website at www.genprex.com.
About Reqorsa® Gene Therapy
REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company's Oncoprex® Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.
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: REQORSA's potential as a therapeutic treatment for Ras inhibitor resistant lung cancer; 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.
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FAQ
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