What's Happening?
Genprex, Inc., a clinical-stage gene therapy company, has announced the addition of the Gabrail Cancer Center in Canton, Ohio, as a new site for its Acclaim-1 and Acclaim-3 clinical trials. These trials are focused on evaluating Reqorsa® Gene Therapy
for treating lung cancer. The Acclaim-1 trial is a Phase 1/2 study combining Reqorsa with AstraZeneca's Tagrisso® for patients with late-stage non-small cell lung cancer (NSCLC) who have EGFR mutations. The Acclaim-3 trial, also a Phase 1/2 study, combines Reqorsa with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC). Both trials have received FDA Fast Track Designation, with Acclaim-3 also receiving Orphan Drug Designation. The expansion aims to increase patient enrollment and expedite the trials.
Why It's Important?
The expansion of Genprex's clinical trials is significant as it potentially accelerates the development of new gene therapies for lung cancer, a disease with limited treatment options. By increasing the number of trial sites, Genprex can enroll more patients, which may lead to faster data collection and analysis. This could expedite the availability of new treatments for patients with NSCLC and ES-SCLC, potentially improving survival rates and quality of life. The FDA's Fast Track and Orphan Drug Designations highlight the importance and urgency of these trials, as they address unmet medical needs in cancer treatment.
What's Next?
Genprex plans to open additional clinical trial sites in the coming months to further expand patient access. The company aims to complete enrollment for the interim analysis of the Acclaim-1 trial by the first half of 2026. Similarly, for Acclaim-3, the interim analysis is expected after the 25th patient reaches 18 weeks of follow-up. These steps are crucial for advancing the trials and potentially bringing Reqorsa to market as a new treatment option for lung cancer patients.
