Genprex Begins Acclaim-3 Phase 2 Trial for Gene Therapy in Lung Cancer Patients

Genprex Launches Phase 2 Expansion of Acclaim-3 Clinical Trial



Genprex, Inc., a clinical-stage gene therapy firm, has announced the commencement of the Phase 2 expansion of its groundbreaking Acclaim-3 clinical trial. This pivotal study evaluates the effectiveness of Reqorsa® Gene Therapy, also known as quaratusugene ozeplasmid, when administered alongside Tecentriq® (atezolizumab) for individuals diagnosed with extensive stage small cell lung cancer (ES-SCLC).

The excitement surrounding this development is palpable. As stated by Dr. Mark Berger, the Chief Medical Officer at Genprex, "We are thrilled to launch this Phase 2 expansion segment of Acclaim-3, aiming to assess the 18-week Progression Free Survival (PFS) rate associated with the Reqorsa and Tecentriq combination." ES-SCLC remains one of the most challenging malignancies, exhibiting a dismal prognosis with a median PFS of 5.2 months. Patients on maintenance therapy with Tecentriq alone exhibit a median PFS of just 2.6 months post-initiation.

The Phase 2 expansion program is set to involve around 50 participants, who will be treated across 10 to 15 clinical sites located throughout the United States. These patients will receive the combination therapy of Reqorsa and Tecentriq until there is noticeable disease progression or intolerable toxicity. The trial's primary objective is to confirm the 18-week PFS rate after the start of maintenance therapy. Importantly, a preliminary analysis will occur once the first 25 patients have been enrolled and followed up for 18 weeks, anticipated in the latter half of 2025.

This innovative therapeutic approach has garnered attention due to its previous accolades, including Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). These designations underscore the pressing need for more effective treatment options within the ES-SCLC patient population, who often face limited choices.

Genprex has developed a unique cancer treatment paradigm that utilizes gene therapy to revive tumor suppressor genes often lost or malfunctioning in cancer cells. REQORSA specifically aims to express TUSC2, a protein heavily involved in tumor suppression. Notably, research indicates that nearly 100% of SCLC cases exhibit diminished or absent TUSC2 protein expression.

Further, studies showcased at the October 2023 AACR-NCI-EORTC International Conference highlighted the efficacy of the Reqorsa and Tecentriq duo, demonstrating significantly improved tumor control in experimental models compared to either agent alone. This compelling data provides a strong rationale for continuing this research into human clinical trials.

Overview of Acclaim-3


The Acclaim-3 trial marks an open-label, multi-center Phase 1/2 investigation into how Reqorsa and Tecentriq function as maintenance therapy for patients with ES-SCLC, particularly following standard chemotherapy and initial treatments. Given the high stakes of advancements in this field, Genprex is focusing on developing durable treatments that not only prolong survival but also enhance quality of life for those battling advanced lung cancer.

Genprex: A Vision for Tomorrow


Genprex, Inc. firmly believes in its mission to transform treatment options for cancer and diabetes patients. By leveraging advanced technologies, including an innovative delivery system for gene therapies, the company aspires to establish its position at the forefront of gene therapy developments. Each of its oncology-focused programs, including those targeting NSCLC and SCLC, carry the FDA's Fast Track designation, highlighting their commitment to rapid and impactful clinical advancements.

Moreover, Genprex's diabetes project aims to utilize gene therapy to restore normal pancreatic function. Their approach demonstrates promising results, showcasing the potential to convert pancreatic cells into functional insulin-producing cells, thus aiming to tackle the challenges associated with Type 1 and Type 2 diabetes.

In summary, as Genprex embarks on the Phase 2 expansion of the Acclaim-3 trial, the biotechnology space watches intently. With the potential to redefine treatment for ES-SCLC patients, the company exemplifies a blend of innovation, hope, and perseverance in the face of daunting medical challenges. Investors and stakeholders keen on advancing healthcare solutions can stay updated through Genprex's official channels, ensuring they are informed of this transformational journey in cancer treatment.

Topics Health)

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