Genprex Expands Lung Cancer Trials with New Clinical Site Addition
New Clinical Trial Site Added for Clinical Studies of Reqorsa Gene Therapy to Treat Lung Cancer
Acclaim-1 and Acclaim-3 Clinical Trials Supported by FDA Fast Track Designation
Genprex, Inc. (NASDAQ: GNPX), a pioneering gene therapy company dedicated to creating impactful treatments for individuals battling cancer and diabetes, has just announced a significant development in its ongoing lung cancer research. The Company has welcomed Gabrail Cancer Center as a new clinical trial site for the Acclaim-1 and Acclaim-3 studies focused on its lead drug candidate, Reqorsa Gene Therapy. This addition aims to extend the reach of these vital trials, empowering more patients with access to innovative treatment options.
Ryan Confer, President and CEO of Genprex, expressed enthusiasm about collaborating with Gabrail Cancer Center, a respected facility devoted to patient-centered care. He stated, “This collaboration not only increases the number of trial sites but also enhances our ability to enroll more patients in these critical lung cancer trials. Accelerating patient enrollment is essential to get our gene therapy treatment into the hands of those who need it most.”
Overview of Acclaim-1 Trial
Acclaim-1 is a Phase 1/2 clinical trial that investigates the effectiveness of Reqorsa in combination with AstraZeneca’s Tagrisso (osimertinib) to treat patients suffering from advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have shown disease progression after Tagrisso treatment.
The successful completion of the initial dose escalation phase of this trial indicated that Reqorsa is generally well tolerated without any severe side effects, even at higher doses. Furthermore, noteworthy outcomes include early efficacy signals, as some participants have reported prolonged periods of stability in their disease progression, while one patient even achieved a partial response.
Upcoming plans for the Phase 2a expansion will involve enrolling around 33 patients who have previously undergone Tagrisso treatment. The study aims to determine the safety of Reqorsa and assess its effectiveness along with additional exploratory endpoints. Genprex's team is enthusiastic about conducting an interim analysis following the treatment of 19 patients, anticipated to occur in the first half of the following year.
Insights into Acclaim-3 Trial
Acclaim-3 is another Phase 1/2 clinical trial, this time evaluating the pairing of Reqorsa with Genentech’s Tecentriq (atezolizumab) as continuing therapy for patients diagnosed with extensive stage small cell lung cancer (ES-SCLC). These individuals are candidates for maintenance therapy following initial standard treatments involving Tecentriq and chemotherapy.
Like Acclaim-1, the initial phase of Acclaim-3 has shown promising results with regards to the safety of Reqorsa, leading to no reported severe toxic reactions. The second phase expects to include approximately 50 patients, focusing mainly on tracking their progression-free survival rate after they begin maintenance therapy with Reqorsa and Tecentriq.
The enrolled patients will be closely monitored for overall survival rates as well. An interim analysis is planned after 25 patients have reached 18 weeks of follow-up. The team hopes to complete this first set of patients in the early part of next year. Notably, Acclaim-3 has also received Fast Track Designation and Orphan Drug Designation from the FDA.
About Genprex, Inc.
Genprex, Inc. specializes in advancing clinical-stage gene therapies aimed at transforming the treatment landscape for patients grappling with cancer and diabetes. The company’s innovative strategies are built on delivering targeted genes that can offer solutions to large populations facing limited treatment options. Genprex collaborates with leading research institutions to develop drug candidates that aim to expand its pipeline of life-changing gene therapies.
Utilizing its unique non-viral Oncoprex Delivery System, Genprex’s technologies encapsulate therapeutic genes within lipid-based nanoparticles, which are administered intravenously, allowing tumor cells to benefit from vital tumor suppressor proteins that they previously lacked. Among Genprex’s leading product candidates is Reqorsa Gene Therapy, currently in the spotlight within both NSCLC and SCLC trials.
Investor Engagement and Company Initiatives
Genprex encourages investors and interested parties to stay updated on its milestones and research developments by registering via its official website. The Company is committed to transparency and constant communication, inviting engagement through various platforms including Twitter, Facebook, and LinkedIn.
Frequently Asked Questions
What is Reqorsa Gene Therapy?
Reqorsa Gene Therapy is Genprex's lead product candidate focused on treating lung cancer through gene therapy mechanisms.
How many patients are involved in the Acclaim trials?
The Acclaim-1 trial plans to enroll approximately 33 patients, while Acclaim-3 will include around 50 patients.
What designations have Acclaim-1 and Acclaim-3 received?
Both trials have received Fast Track Designation from the FDA, facilitating their clinical development.
What partnerships does Genprex engage in?
Genprex collaborates with top-tier institutions and organizations to develop its gene therapy candidates and enhance its drug pipeline.
What are the future plans for Genprex's trials?
Genprex aims to open more trial sites and expedite patient enrollment for the Acclaim trials, enhancing access to this innovative therapy.
