Genprex Announces First Patient Dosed in Phase 2 Expansion Portion of Acclaim-3 Clinical Study of Reqorsa® Gene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer
Genprex (NASDAQ: GNPX) has announced the dosing of the first patient in the Phase 2 expansion portion of its Acclaim-3 clinical study, evaluating Reqorsa® Gene Therapy combined with Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC).
The Phase 2 expansion will enroll 50 patients across 10-15 U.S. sites, with an interim analysis planned after the first 25 patients reach 18 weeks of follow-up, expected in the second half of 2025. The study's primary endpoint is to determine the 18-week progression-free survival rate.
Current ES-SCLC patients have a median progression-free survival of 5.2 months, with those receiving Tecentriq maintenance therapy showing 2.6 months. The treatment combination has received both FDA Fast Track and Orphan Drug Designations. Preclinical data from October 2023 showed the combination therapy provided better tumor control than either agent alone.
Genprex (NASDAQ: GNPX) ha annunciato la somministrazione del primo paziente nella fase di espansione di fase 2 del suo studio clinico Acclaim-3, che valuta la Terapia Genica Reqorsa® combinata con Tecentriq® come terapia di mantenimento per il cancro polmonare a piccole cellule in stadio avanzato (ES-SCLC).
La fase di espansione di fase 2 arruolerà 50 pazienti in 10-15 sedi negli Stati Uniti, con un'analisi intermedia pianificata dopo che i primi 25 pazienti avranno raggiunto 18 settimane di follow-up, previsto nella seconda metà del 2025. L'obiettivo primario dello studio è determinare il tasso di sopravvivenza libera da progressione a 18 settimane.
Attualmente, i pazienti con ES-SCLC hanno una sopravvivenza mediana libera da progressione di 5,2 mesi, mentre quelli che ricevono terapia di mantenimento con Tecentriq mostrano 2,6 mesi. La combinazione di trattamenti ha ricevuto sia la designazione Fast Track della FDA che quella di Farmaco Orfano. Dati preclinici di ottobre 2023 hanno dimostrato che la terapia combinata ha fornito un miglior controllo tumorale rispetto a ciascun agente da solo.
Genprex (NASDAQ: GNPX) ha anunciado la dosificación del primer paciente en la parte de expansión de fase 2 de su estudio clínico Acclaim-3, que evalúa la Terapia Génica Reqorsa® combinada con Tecentriq® como terapia de mantenimiento para el cáncer de pulmón de células pequeñas en estadio avanzado (ES-SCLC).
La expansión de fase 2 inscribirá a 50 pacientes en 10-15 sitios de EE. UU., con un análisis intermedio planeado después de que los primeros 25 pacientes alcancen 18 semanas de seguimiento, que se espera que ocurra en la segunda mitad de 2025. El objetivo primario del estudio es determinar la tasa de supervivencia libre de progresión a 18 semanas.
Los pacientes actuales de ES-SCLC tienen una supervivencia media libre de progresión de 5,2 meses, mientras que aquellos que reciben la terapia de mantenimiento con Tecentriq muestran 2,6 meses. La combinación de tratamientos ha recibido tanto la designación Fast Track de la FDA como la de Medicamento Huérfano. Los datos preclínicos de octubre de 2023 mostraron que la terapia combinada proporcionó un mejor control tumoral que cada agente por separado.
젠프렉스 (NASDAQ: GNPX)는 Reqorsa® 유전자 요법과 Tecentriq®를 결합한 치료법이 진행성 소세포 폐암(ES-SCLC)의 유지 요법으로 평가되는 Acclaim-3 임상 연구의 2상 확장 부분에서 첫 번째 환자에 대한 용량 투여를 발표했습니다.
2상 확장은 미국의 10-15개 사이트에서 50명의 환자를 모집할 예정이며, 초기 분석은 첫 25명의 환자가 18주 추적 관찰에 도달한 후 계획되어 있으며, 예상 시기는 2025년 하반기입니다. 연구의 주요 목표는 18주 진행 무료 생존율을 결정하는 것입니다.
현재의 ES-SCLC 환자들은 중앙 진행 무료 생존 기간이 5.2개월이며, Tecentriq 유지 요법을 받는 환자들은 2.6개월을 보이고 있습니다. 치료 조합은 FDA의 패스트트랙 및 오르판 약물 지정을 모두 받았습니다. 2023년 10월의 전임상 데이터는 조합 요법이 단일 약제보다 더 나은 종양 조절을 제공함을 보여주었습니다.
Genprex (NASDAQ: GNPX) a annoncé la dose du premier patient dans la partie d'expansion de phase 2 de son étude clinique Acclaim-3, évaluant la Thérapie Génétique Reqorsa® combinée avec Tecentriq® en tant que thérapie d'entretien pour le cancer du poumon à petites cellules en stade étendu (ES-SCLC).
La phase d'expansion de phase 2 recrutera 50 patients dans 10 à 15 sites aux États-Unis, avec une analyse intérimaire prévue après que les 25 premiers patients auront atteint 18 semaines de suivi, prévue pour la seconde moitié de 2025. L'objectif principal de l'étude est de déterminer le taux de survie sans progression de 18 semaines.
Les patients souffrant d'ES-SCLC ont actuellement une survie médiane sans progression de 5,2 mois, tandis que ceux recevant la thérapie de maintien avec Tecentriq montrent 2,6 mois. La combinaison de traitements a reçu à la fois la désignation Fast Track de la FDA et celle de médicament orphan. Les données précliniques d'octobre 2023 ont montré que la thérapie combinée offrait un meilleur contrôle tumoral que chacun des agents seuls.
Genprex (NASDAQ: GNPX) hat die Dosierung des ersten Patienten im Phase-2-Erweiterungsbereich seiner klinischen Studie Acclaim-3 bekannt gegeben, die die Reqorsa® Gentherapie in Kombination mit Tecentriq® als Erhaltungsbehandlung für das ausgedehnte kleinzellige Lungenkarzinom (ES-SCLC) evaluiert.
Die Phase-2-Erweiterung wird 50 Patienten an 10-15 Standorten in den USA einschreiben, mit einer geplanten Zwischenanalyse nach den ersten 25 Patienten, die 18 Wochen Nachbeobachtung erreicht haben, die für die zweite Jahreshälfte 2025 erwartet wird. Das primäre Ziel der Studie besteht darin, die 18-wöchige progressionsfreie Überlebensrate zu bestimmen.
Aktuelle ES-SCLC-Patienten haben ein medianes progressionsfreies Überleben von 5,2 Monaten, während diejenigen, die Tecentriq als Erhaltungsbehandlung erhalten, 2,6 Monate erreichen. Die Kombinationstherapie erhielt sowohl die FDA Fast Track- als auch die Orphan Drug-Bezeichnungen. Vorläufige Daten aus Oktober 2023 zeigten, dass die Kombinationstherapie eine bessere Tumorkontrolle als jedes Einzelmittel allein bot.
- FDA granted Fast Track and Orphan Drug Designations for the treatment
- Preclinical data shows improved tumor control with combination therapy
- Study targets an unmet medical need in ES-SCLC with poor survival rates
- Extended timeline for interim analysis (H2 2025)
- Requires enrollment of 50 patients across multiple sites, which could face recruitment challenges
Insights
This Phase 2 expansion milestone represents a significant advancement in Genprex's clinical development program for Reqorsa. The study design is particularly noteworthy, targeting an aggressive form of lung cancer with historically poor outcomes - extensive stage SCLC patients show a median progression-free survival of just 5.2 months.
The dual regulatory designations are important advantages:
- Fast Track Designation enables expedited development and review process
- Orphan Drug Designation provides market exclusivity and development incentives
The scientific approach is innovative, addressing a fundamental cancer mechanism through TUSC2 tumor suppressor gene restoration. This is particularly relevant as nearly 100% of SCLC cases show reduced TUSC2 expression, with 41% completely lacking it. The preclinical data showing enhanced tumor control with the Reqorsa-Tecentriq combination provides a strong mechanistic rationale.
The timeline for interim analysis in H2 2025 suggests careful strategic planning. While this may seem distant, it's reasonable given the complexity of patient recruitment in rare cancer trials and the need for 18-week follow-up periods. The two-stage design with an interim analysis after 25 patients allows for early efficacy assessment while managing development risks.
However, investors should note that this is still an early-stage trial and success in mouse models doesn't guarantee clinical efficacy. The key value inflection point will be the interim analysis results, which could provide important insights into the therapy's potential.
Expects to Complete Enrollment of First 25 Patients in Phase 2 Expansion Study During Second Half of 2025 for Interim Analysis
Acclaim-3 Study Has FDA Orphan Drug and Fast Track Designations
"We are excited to begin the Phase 2 expansion portion of Acclaim-3, which will determine the 18-week Progression Free Survival (PFS) rate of REQORSA and Tecentriq combination maintenance therapy," said Mark Berger, MD, Chief Medical Officer at Genprex. "ES-SCLC has a poor prognosis with a median PFS of 5.2 months. Those patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. We look forward to studying the combination of REQORSA and Tecentriq as we work to advance our innovative gene therapy."
The Phase 2 expansion portion will enroll 50 patients at approximately 10 to 15 U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 interim analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients in the second half of 2025 for interim analysis.
The combination of REQORSA and Tecentriq previously received the
Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly
Data presented at the October 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics from studies in humanized mouse models of SCLC that use human H841 SCLC cells have shown that the combination of REQORSA and Tecentriq provides significantly better control of tumor burden than either agent alone. The data from these studies also suggest that a combination treatment of REQORSA and Tecentriq can promote a significantly increased tumor cell killing effect in SCLC xenografts compared to that of Tecentriq alone.
About Acclaim-3
The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with Genentech, Inc.'s Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.
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, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, 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, 2023.
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, such as REQORSA in combination with other therapies in SCLC; the timing and success of Genprex's clinical trials and regulatory approvals, including, but not limited to, the enrollment of the Phase 2 expansion portions of the Acclaim-3 trial; 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.
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