Genprex Expands Clinical Trial Sites for Innovative Lung Cancer Treatment

In a significant move to enhance patient accessibility for clinical trials, Genprex, Inc., a clinical-stage gene therapy company, has announced the addition of Gabrail Cancer Center in Canton, Ohio, as a new site for its Acclaim-1 and Acclaim-3 lung cancer clinical trials. This follows the company's ongoing commitment to develop groundbreaking therapies for patients battling cancer and diabetes.

Genprex's lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is currently being investigated in these trials, which have received the FDA's Fast Track Designation, indicating the agency's recognition of their potential to meet unmet medical needs.

Collaboration with Gabrail Cancer Center

Ryan Confer, President and CEO of Genprex, expressed enthusiasm about partnering with Gabrail Cancer Center, noting that it is a well-established facility focused on patient care. This collaboration aims to expand the number of clinical trial sites, thereby increasing access for patients interested in participating in the trials for this innovative gene therapy.

Confer highlighted that the partnership is expected to accelerate patient enrollment, allowing more individuals to benefit from this promising treatment option. The intention is to initiate additional clinical sites in the coming months to further broaden the reach and expedite the enrollment process.

Overview of the Acclaim-1 and Acclaim-3 Trials

The Acclaim-1 trial is a Phase 1/2 study designed to evaluate the effectiveness of combining Reqorsa with AstraZeneca's Tagrisso® (osimertinib) for treating late-stage non-small cell lung cancer (NSCLC). This study targets patients with activating EGFR mutations who have seen disease progression after Tagrisso treatment. Early trials have shown that Reqorsa is generally well tolerated, with encouraging results regarding progression-free survival.

In contrast, the Acclaim-3 study appraises the effectiveness of Reqorsa in combination with Genentech's Tecentriq® (atezolizumab) as a maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC) candidates. It aims to determine the safety profile and efficacy of the combination until disease progression occurs. Like the Acclaim-1 trial, the Acclaim-3 trial has also seen a successful completion of its Phase 1 dose-escalation phase, with no dose-limiting toxicities identified.

Genprex's ongoing trials emphasize their commitment to developing non-viral, systemic gene therapies designed to combat cancer. Their innovative Oncoprex® Delivery System encapsulates gene-expressing plasmids in lipid-based nanoparticles, enabling intravenous administration that targets tumor cells effectively. By doing so, tumors can express tumor suppressor proteins vital for combating cancerous growths.

Future Plans and Expectations

Both trials are expected to enroll a substantial number of patients in the upcoming months, with Genprex planning interim analyses to assess the results and safety profiles of the therapies throughout the studies. The company anticipates completing enrollment of the first cohort of patients in the first half of 2026.

As a company that consistently strives to innovate in gene therapy, Genprex, which is traded on NASDAQ under the ticker GNPX, continues to work closely with leading research institutions and collaborators. The aim is to introduce new therapies to large patient populations currently facing limited treatment options, particularly in the fields of oncology and diabetes.

Investors and stakeholders are encouraged to remain updated on Genprex's advances by subscribing to their press releases and following their progress on platforms like Twitter, Facebook, and LinkedIn.

In summary, the addition of new sites for clinical trials like those at Gabrail Cancer Center not only showcases Genprex's drive to enhance patient treatment access but also represents a significant step forward in the development of effective therapies for challenging cancers. With promising early results and FDA support, there is potential for these trials to contribute greatly to the ongoing fight against lung cancer.