Genprex Shares Positive Updates from Acclaim-1 and Acclaim-3 Lung Cancer Trials

Genprex, Inc., a clinical-stage gene therapy company, has announced encouraging updates on its Acclaim-1 and Acclaim-3 clinical trials, which focus on treating non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) respectively. The trials are utilizing the company's innovative drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy, which has shown promising results in early patient responses.

The Acclaim-1 trial combines REQORSA with AstraZeneca’s Tagrisso® to treat late-stage NSCLC patients with EGFR mutations whose disease has progressed after Tagrisso treatment. Notably, two patients in the Phase 1 dose escalation portion have experienced prolonged Progression Free Survival (PFS). One patient, treated for over two years, achieved a Partial Remission (PR) after the second course of REQORSA and Tagrisso and has maintained this response since. Another patient has shown stable disease without progression for more than 15 months.

Ryan Confer, Genprex’s President and CEO, expressed optimism regarding the early patient responses, emphasizing the pressing need for new therapies for lung cancer patients, whose disease generally progresses even with advanced treatments. He highlighted the potential of REQORSA in addressing this unmet medical need, showcasing early signs of efficacy and a favorable safety profile.

The Acclaim-1 trial has received FDA Fast Track Designation for late-stage NSCLC patients whose disease has progressed after Tagrisso treatment. The Phase 2a expansion portion of the trial is being streamlined to focus on patients who have previously received only Tagrisso, aiming to enroll approximately 33 patients for interim analysis by the first half of 2025. The Phase 2b randomized portion will continue as planned, comparing REQORSA and Tagrisso combination therapy with platinum-based chemotherapy.

In the Acclaim-3 trial, REQORSA is combined with Genentech’s Tecentriq® as a maintenance therapy for extensive stage small cell lung cancer (ES-SCLC) patients whose tumors have not progressed after initial treatment with Tecentriq and chemotherapy. The FDA has granted both Fast Track and Orphan Drug Designations for this patient population.

The first patient treated in Acclaim-3’s Phase 1 dose escalation portion showed a Partial Remission (PR), with a 30% reduction in tumor size after two cycles of maintenance therapy. Although there was a progression in an unmeasurable lesion after three months, this early response suggests potential clinical benefits from REQORSA. Dr. Mark Berger, Genprex’s Chief Medical Officer, noted that such a response is rare during Tecentriq maintenance therapy alone, highlighting the promising nature of these early results. The Phase 2 expansion portion is expected to commence in the latter half of 2024.

Genprex's unique gene therapy approach aims to re-express tumor suppressor genes, which are frequently inactive in cancers. REQORSA utilizes a plasmid to reintroduce the TUSC2 gene, crucial for cancer suppression and normal cell metabolism. Nonclinical studies support the hypothesis that re-expressing TUSC2 in combination with Tecentriq could enhance clinical efficacy in SCLC.

The company is also focusing on refining its oncology clinical development program. The Acclaim-2 trial has been discontinued due to challenges in patient recruitment amidst numerous competing trials. Instead, Genprex is prioritizing resources towards the Acclaim-1 and Acclaim-3 trials. Additionally, the company is collaborating with an academic research partner to develop biomarkers that could refine patient selection and improve trial outcomes.

Genprex continues to advance its pipeline with the aim of offering new therapeutic options for cancer and diabetes patients. The company's innovative approaches leverage systemic, non-viral delivery systems to administer gene therapies, holding promise for significant clinical benefits.